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Peg-Ifn Dose Evaluations for Previously Untreated Subjects with Chronic Hepatitis C Infected with Genotype 1 - Article


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Hepatitis B



Clinical Trial: Peg-Ifn Dose Evaluations for Previously Untreated Subjects with Chronic Hepatitis C Infected with Genotype 1

This study is currently recruiting patients.

Sponsored by: Schering-Plough
Information provided by: Schering-Plough

Purpose

The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PEG-Intron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PEG-Intron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.

Condition Treatment or Intervention Phase
Chronic Hepatitis C
  Drug: PEG-Intron Plus REBETOL
 Drug: PEGASYS Plus COPEGUS
 Phase III

MedlinePlus related topics:  Hepatitis;   Hepatitis C

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title: Comparison of PEG-Intron 1.5µg/kg/wk Plus REBETOL vs PEG-Intron 1µg/kg/wk Plus REBETOL vs PEGASYS 180µg/wk Plus COPEGUS in Previously Untreated Adult Subjects With Chronic Hepatitis C Infected with Genotype 1

Further Study Details: 

Expected Total Enrollment:  2880

Study start: March 2004;  Expected completion: July 2006

PEG-Intron Dose: Screening 2 Weight 40-50 kg Volume to Inject (mL)0.22; Screening 2 Weight 51-60 kg Volume to Inject (mL)0.28; Screening 2 Weight 61-75 kg Volume to Inject (mL)0.33; Screening 2 Weight 76-85 kg Volume to Inject (mL)0.41; Screening 2 Weight 86-104 kg Volume to Inject (mL)0.48; Screening 2 Weight 105-125 kg Volume to Inject (mL)0.58 from two vials

REBETOL Dosage (for Use With PEG-INTRON): Screening 2 Weight 40-60 kg Daily Dose 800mg; Screening 2 Weight >65-85 kg Daily Dose 1000mg; Screening 2 Weight >85-105 kg Daily Dose 1200mg; Screening 2 Weight >105-125 kg Daily Dose 1400mg

The PEGASYS dose of 1 mL (180 µg) will be administered once weekly subcutaneously on the same day of the week

COPEGUS Dosage (for Use With PEGASYS): Screening 2 Weight <75kg Daily Dose 1000mg; Screening 2 Weight > or = 75kg Daily Dose 1200mg

NOTE: Double Blind for PEG-Intron; Open Label for REBETOL, PEGASYS and COPEGUS

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:

  • Previously untreated adults with chronic hepatitis C (HCV RNA qPCR plasma positive)
  • Individuals with HCV genotype 1 (mixed 1a/1b is acceptable)
  • Compensated liver disease
  • No significant co-existing psychiatric disease
  • Historic liver biopsy slides available
  • Adults aged 18-70
  • Individuals weighing 88-275 pounds (40-125 kg)
  • Free from substance abuse for past 2 years
  • Those suffering from diabetes and/or hypertension must have normal eye exams and retinal photographs (these will be done as part of the study before hepatitis C treatment is given)
  • Patients and partners of patients willing to use adequate contraception during the course of the study
  • Hematology laboratory results of: * Hemoglobin (HGB) > 12 g/dL for females or > 13g/dL for males * White Blood Cell Count (WBC) > 3,000 mm3 * Neutrophils > 1,500 mm3 * Platelets > 80,000 mm3
  • Chemistry laboratory results of: * Normal Thyroid Stimulating Hormone (TSH), albumin, creatinine, and direct bilirubin * Antinuclear antibody (ANA) < 1:320 * Fasting Glucose 70-140 mg/dL Note: If glucose levels are between 116-140 mg/dL or an individual has diabetes, HbA1C must be < 8.5

EXCLUSION CRITERIA:

  • Previous hepatitis C treatment
  • Pregnant women or partners of pregnant women
  • Patients or partners of patients who intend to become pregnant any time during the 48 weeks
  • Women who are breast feeding
  • People with liver disease not caused by hepatitis C
  • Individuals infected with the hepatitis B virus and/or human immunodeficiency virus (HIV)
  • Patients with a history of liver cancer (hepatocellular carcinoma)
  • Known blood disorders such as hemoglobinopathy, coagulopathy, or G6PD deficiency
  • Body organ transplant
  • Any known or suspected cancer within the past 5 years
  • Individuals who currently use EPO, G-CSF and/or GM-CSF
  • Those having a history of or active clinical gout
  • People who have chronic pulmonary disease
  • Individuals who have a medical condition that would likely require systemic steroids
  • Those with a history of central nervous system (CNS trauma) or seizure disorders
  • Current or previous use of lithium or antipsychotic drugs
  • Individuals who currently have or show signs of moderate to severe depression
  • Patients with clinically significant electrocardiogram (ECG) abnormalities
  • Individuals with serious heart problems such as those who have had a heart attack, high blood pressure, or other heart problems
  • Patients that weigh > 231-275 pounds (105-125 kg) AND have a body mass index (BMI) > 30 AND have 3 or more of the risk factors below: (a) Strong family history of coronary heart disease (CHD) which includes 2 or more first-degree relatives with CHD or family history of early CHD at age < 55 for male relatives or < 65 for female relatives (b) People with abnormal total cholesterol and/or sub fractions (uncontrolled hypercholesterolemia) (c) Diabetes (d) Hypertension (e) Smoking

Location and Contact Information


Alabama
      University of South AL, Mobile,  Alabama,  36693,  United States; Recruiting
Jorge Herrera  251-660-5553    unknown 
Emilie Barnett  251-660-5553    unknown 
Jorge Herrera,  Principal Investigator

      University of AL at Birmingham Liver Center, Birmingham,  Alabama,  35294,  United States; Recruiting
Aasim Sheikh  205-975-5676    tgwaltney@uabmc.edu 
Tracey Gwaltney  205-975-5676    tgwaltney@uabmc.edu 
Aasim Sheikh,  Principal Investigator

Arizona
      University of Arizona Liver Research Institute, Tucson,  Arizona,  85724,  United States; Recruiting
Thomas Boyer  520-626-3735    dbwebb@u.arizona.edu 
Donna Webb  520-626-3735    dbwebb@u.arizona.edu 
Thomas Boyer,  Principal Investigator

California
      Kaiser Permanente, Sacramento,  California,  95825,  United States; Recruiting
Mary Pat Pauly  916-973-7042    gayle.witt@kp.org 
Gayle Witt  916-973-5782    gayle.witt@kp.org 
Mary Pat Pauly,  Principal Investigator

      VA Medical Center - 11, Long Beach,  California,  90822,  United States; Recruiting
Timothy Morgan  562-826-5933    marlene.stjohn@med.va.gov 
Marlene St. John  562-826-5933    marlene.stjohn@med.va.gov 
Timothy Morgan,  Principal Investigator

      SCPMG, San Diego,  California,  92173,  United States; Recruiting
Lisa M Nyberg  619-662-5400    unknown 
Karen Cloutman  619-528-6550    unknown 
Lisa M. Nyberg,  Principal Investigator

      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States; Recruiting
Fred Poordad  310-423-3949    clarkej@cshs.org 
Janet Clarke  310-423-2337    clarkej@cshs.org 
Fred Poordad,  Principal Investigator

      University of California Irvine Medical Center, Orange,  California,  92868,  United States; Recruiting
Ke-Qin Hu  714-456-6745    nkyulo@uci.edu 
Namgyal Kyulo  714-456-6925    nkyulo@uci.edu 
Ke-Qin Hu,  Principal Investigator

      University of California, Davis Sacremento Medical Center (UCDMC), Sacramento,  California,  95817,  United States; Recruiting
Lorenzo Rossaro  916-734-8685    laura.lester@ucdemc.ucdavis.edu 
Laura Lester  916-734-8694    laura.lester@ucdemc.ucdavis.edu 
Lorenzo Rossaro,  Principal Investigator

      Kaiser Permanente, Santa Clara,  California,  95051,  United States; Recruiting
Joanna Ready  408-236-4149    unknown 
Lynne Sugimoto  408-236-4989    unknown 
Joanna Ready,  Principal Investigator

      San Francisco General Hospital, San Francisco,  California,  94110,  United States; Recruiting
Mandana Khalili  415-206-4766    asharabidze@meds.fgh.ucsf.edu 
Annie Sharabidze  415-206-4061    asharabidze@meds.fgh.ucsf.edu 
Khalili Mandana,  Principal Investigator

      Southern California Kaiser Permanente Medical Group, San Marcos,  California,  92069,  United States; Recruiting
Anders Nyberg  619-662-5410    unknown 
Nancy Crowe  619-662-5410    unknown 
Anders Nyberg,  Principal Investigator

Colorado
      South Denver Gastroenterology, PC, Englewood,  Colorado,  80110,  United States; Recruiting
Marcelo Kugelmas  303-788-8888    unknown 
Lu Antronica  303-788-8888  Ext. 139    unknown 
Marcelo Kugelmas,  Principal Investigator

Connecticut
      Connecticut Gastroenterology & Medical Associates, Hartford,  Connecticut,  06106,  United States; Recruiting
Jonathan Israel  860-246-2571    swardla@harthosp.org 
Michele Wardlaw  610-524-4328    swardla@harthosp.org 
Jonathan Israel,  Principal Investigator

      GI Division UConn Health Center, Farmington,  Connecticut,  06030,  United States; Recruiting
George Wu  860-679-3878    unknown 
Martha Schwartz  860-679-3878    unknown 
George Wu,  Principal Investigator

District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307,  United States; Recruiting
Maria Sjogren  202-782-6389    brooke.huntley@na.amedd.army.mil 
Brooke Huntley  202-782-6390    brooke.huntley@na.amedd.army.mil 
Maria Sjogren,  Principal Investigator

Florida
      South Florida Center of Gastroenterology, P.A., Wellington,  Florida,  33414,  United States; Recruiting
Mitchell Davis  561-798-2425    sslctrgi@bellsouth.net 
Viola Kauthen  561-798-9025    sslctrgi@bellsouth.net 
Mitchell Davis,  Principal Investigator

      Bach and Godofsky, MD PA, Bradenton,  Florida,  34205,  United States; Recruiting
Eliot Godofsky  941-746-2711    minursenp@aol.com 
Michele Mays  941-746-2711  Ext. 24    minursenp@aol.com 
Eliot Godofsky,  Principal Investigator

      Miami Research Associates, Miami,  Florida,  33173,  United States; Recruiting
Lawrence Rothman  305-913-0666    lrothman@gicarecenter.com 
Margarita Mederos  305-279-0015  Ext. 4208    lrothman@gicarecenter.com 
Lawrence Rothman,  Principal Investigator

      University of Miami Center for Liver Diseases, Miami,  Florida,  33136,  United States; Recruiting
Eugene Schiff  305-243-2854    unknown 
Johanna Stamates  305-243-2854    unknown 
Eugene Schiff,  Principal Investigator

Georgia
      Digestive Healthcare of Georgia, PC, Atlanta,  Georgia,  30309,  United States; Recruiting
Raymond Rubin  404-355-3200    jewett_deborah@piedmont.org 
Deborah Jewett  404-355-3200  Ext. 158    jewett_deborah@piedmont.org 
Raymond Rubin,  Principal Investigator

      Northwest Georgia Gastroenterology Associates, Marietta,  Georgia,  30060,  United States; Recruiting
Robert Strauss  770-429-0031    cathym@nwgagastro.com 
Cathy Maffei  678-819-4237    cathym@nwgagastro.com 
Robert Strauss,  Principal Investigator

      Kaiser Permanente, Atlanta,  Georgia,  30328,  United States; Recruiting
Christine Bruno  770-677-6261    jeanine.bernstein@kp.org 
Jeanine Bernstein  770-677-6261    jeanine.bernstein@kp.org 
Christine Bruno,  Principal Investigator

Illinois
      Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting
Steven Flamm  312-695-1681    Kspich@aol.com 
Kim Sipich  312-469-4168    Kspich@aol.com 
Steven Flamm,  Principal Investigator

      Digestive Health Services, Downers Grove,  Illinois,  60515,  United States; Recruiting
Rockford Yapp  630-434-9312    unknown 
JoAnn Sandstrom  630-434-9312    unknown 
Rockford Yapp,  Principal Investigator

Indiana
      Indiana University School of Medicine, Indianapolis,  Indiana,  46202,  United States; Recruiting
Paul Kwo  317-274-3090    pasander@iupui.edu 
Patricia Anderson  317-278-2586    pasander@iupui.edu 
Paul Kwo,  Principal Investigator

Iowa
      VA Medical Center Iowa City, Iowa City,  Iowa,  52246-2208,  United States; Recruiting
Warren Schmidt  319-353-7048    donna.evans2@med.va.gov 
Donna Evans  319-338-0581  Ext. 7699    donna.evans2@med.va.gov 
Warren Schmidt,  Principal Investigator

Kentucky
      University of Kentucky, Lexington,  Kentucky,  40536,  United States; Recruiting
Alvaro Koch  859-323-6017    kmmeek0@uky.edu 
Karen Meekins  859-323-6423    kmmeek0@uky.edu 
Alvaro Koch,  Principal Investigator

      University of Louisville, HSC, Louisville,  Kentucky,  40202,  United States; Recruiting
Luis Marsano  502-852-5251    jackie@louisville.edu 
Jackie Stich  502-852-5547    jackie@louisville.edu 
Luis Marsano,  Principal Investigator

Louisiana
      LSU Health Sciences Center, Shreveport,  Louisiana,  71130,  United States; Recruiting
John King  318-675-5902    unknown 
Dana Favrot  318-675-5902    unknown 
John King,  Principal Investigator

      Ochsner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States; Recruiting
Robert Perrillo  504-842-4895    dbaudy@ochsner.org 
Deborah Baudy  (504) 842-4985    dbaudy@ochsner.org 
Robert Perrillo,  Principal Investigator

      Louisiana State University, New Orleans,  Louisiana,  70115,  United States; Recruiting
Luis Balart  504-891-8311    rnorma1@lsuhsc.edu 
Rochelle Norman  (504) 891-8311    rnorma1@lsuhsc.edu 
Luis Balart,  Principal Investigator

      Tulane University Health Science Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Shobha Joshi  504-988-1103    delainna.bartholomew@hcahealthcare.com 
Delainna Bartholomew  504-585-6902    delainna.bartholomew@hcahealthcare.com 
Shobha Joshi,  Principal Investigator

      Louisiana State University, Health Sciences Center, Baton Rouge,  Louisiana,  70805,  United States; Recruiting
William Cassidy  225-358-1065    anicho@lsuhsc.edu 
Amy Lambert  225-358-1287    anicho@lsuhsc.edu 
William Cassidy,  Principal Investigator

Maine
      Hepatitis Treatment Service, Maine Medical Center, Portland,  Maine,  04102,  United States; Recruiting
Alan Kilby  207-871-2099  Ext. 2    unknown 
Virginia Field  207-871-2099  Ext. 2    unknown 
Alan Kilby,  Principal Investigator

Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21287,  United States; Recruiting
Mark Sulkowski  410-614-0454    drosebr1@jhmi.edu 
Danyelle Rosebrough  (410) 614-0454    drosebr1@jhmi.edu 
Mark Sulkowski,  Principal Investigator

      University of Maryland School of Medicine, Baltimore,  Maryland,  21201,  United States; Recruiting
David Oldach  410-706-4609    leeper@umbi.umd.edu 
Rick Leeper  410-706-4601    leeper@umbi.umd.edu 
David Oldach,  Principal Investigator

      Digestive Disease Associates, PA, Baltimore,  Maryland,  21229,  United States; Recruiting
Natarajan Ravendhran  410-247-7500    e.hoverson@ddamd.com / s.shahi@ddamd.com 
Ellen Hoverson  410-737-0053    e.hoverson@ddamd.com / s.shahi@ddamd.com 
Natarajan Ravendhran,  Principal Investigator

Massachusetts
      Lahey Clinic Medical Center, Burlington,  Massachusetts,  01805,  United States; Recruiting
Fredric Gordon  781-744-5330    agnes.trabucco@lahey.org 
Agnes Trabucco  781-744-5330    agnes.trabucco@lahey.org 
Fredric Gordon,  Principal Investigator

      Boston Medical Center, Boston,  Massachusetts,  02118,  United States; Recruiting
Nezam Afdhal  617-638-8330    unknokwn 
Tiffany Geahigan  617-632-1072    unknown 
Nezam Afdhal,  Principal Investigator

      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
Raymond Chung  617-724-7562    rnuzzo1@PARTNERS.ORG 
Rebecca Nuzzo  617-724-3836    rnuzzo1@PARTNERS.ORG 
Raymond Chung,  Principal Investigator

Michigan
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States; Recruiting
Kimberly A Brown  313-916-8865    Aleyson1@hfhs.org 
Anna Leyson-Fiel  313-916-3369    Aleyson1@hfhs.org 
Kimberly A. Brown,  Principal Investigator

      William Beaumont Hospital, Royal Oaks,  Michigan,  48073,  United States; Terminated

Minnesota
      Hennepin County Medical Center, Minneapolis,  Minnesota,  55415,  United States; Recruiting
Craig Peine  612-347-8582    tricia@123mail.net 
Patricia Wanzek  612-347-7683    tricia@123mail.net 
Craig Peine,  Principal Investigator

      Minnesota Clinical Research Center, Plymouth,  Minnesota,  55443,  United States; Recruiting
Coleman Smith  612-870-5570    jwalters@mngastro.com 
Janet Walters  612-870-5596    jwalters@mngastro.com 
Coleman Smith,  Principal Investigator

      VA Medical Center, Minneapolis,  Minnesota,  55417,  United States; Recruiting
Samuel Ho  612-467-4109    lori.tetrick@med.va.gov 
Lori Tetrick  612-467-4149    lori.tetrick@med.va.gov 
Samuel Ho,  Principal Investigator

      Mayo Clinic, Rochester,  Minnesota,  55905,  United States; Recruiting
John Gross  507-284-4823    unknown 
Stephanie Johnson  507-284-9709    unknown 
John Gross,  Principal Investigator

Missouri
      VA Medical Center, Kansas City,  Missouri,  64128,  United States; Recruiting
Prashant Pandya  816-861-4700    karen.luken@med.va.gov 
Karen Luken  816-861-4700    karen.luken@med.va.gov 
Prashant Pandya,  Principal Investigator

      St. Louis University, St. Louis,  Missouri,  36110,  United States; Recruiting
Bruce Bacon  314-577-8764    rauscher@slu.edu 
Judy Thompson  314-977-9388    rauscher@slu.edu 
Bruce Bacon,  Principal Investigator

      University of Missouri-Columbia, Columbia,  Missouri,  65212,  United States; Terminated

      Bradley Freilich, M.D., LLC, Kansas City,  Missouri,  64131,  United States; Recruiting
Bradley Freilich  816-361-0055    unknown 
Erin Downs  816-361-0055    unknown 
Bradley Freilich,  Principal Investigator

      Washington University School of Medicine, St. Louis,  Missouri,  63110,  United States; Recruiting
Jeffrey Crippin  314-454-8160    unknown 
Janet Riley  314-454-8160    unknown 
Jeffrey Crippin,  Principal Investigator

      Mercy St. John's, Springfield,  Missouri,  65804,  United States; Recruiting
Allan Weston  417-820-5200    kweaver@sprg.mercy.net 
Kelly Weaver  417-889-6674  Ext. 264    kweaver@sprg.mercy.net 
Allan Weston,  Principal Investigator

Nebraska
      Gastroenterology Specialists, PC, Lincoln,  Nebraska,  68503,  United States; Recruiting
Douglas Dalke  402-465-4545    unknown 
Janet Griffin  402-465-4545    unknown 
Douglas Dalke,  Principal Investigator

      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-2000,  United States; Recruiting
Mark Mailliard  402-559-4015    mcapadano@unmc.edu 
Mary Capadano  (402) 559-3652    mcapadano@unmc.edu 
Mark Malliard,  Principal Investigator

New Jersey
      Affiliates in Gastroenterology, PA, Florham Park,  New Jersey,  07932,  United States; Recruiting
Lawrence Stein  973-410-0960    unknown 
Donna J Fanelli  973-410-1800  Ext. 19    unknown 
Lawrence Stein,  Principal Investigator

New York
      North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
David Bernstein  516-562-4281    mchhua@nshs.edu 
Maly Tiev  516-562-1364    mchhua@nshs.edu 
David Bernstein,  Principal Investigator

      University Hospital-SUNY Upstate Medical University, Syracuse,  New York,  13210,  United States; Recruiting
Robert Levine  315-464-5804    kushnerk@upstate.edu 
Karyn Kushner  315-464-5794    kushnerk@upstate.edu 
Robert Levine,  Principal Investigator

      Bronx VA Medical Center, Bronx,  New York,  10468,  United States; Recruiting
Norbert Brau  718-584-9000    unknown 
Norbert Brau,  Principal Investigator

      VA New York Harbor Healthcare System, New York,  New York,  10010,  United States; Recruiting
Edmund Bini  212-686-7500    stanley.john@med.va.gov 
Stanley John  212-686-7500  Ext. 4477    stanley.john@med.va.gov 
Edmund Bini,  Principal Investigator

      Weill Medical College of Cornell University, New York,  New York,  10021,  United States; Recruiting
Ira Jacobson  212-746-2115    pms2002@med.cornell.edu 
Piali Samanta  212-746-2114    pms2002@med.cornell.edu 
Ira Jacobson,  Principal Investigator

      Beth Israel Medical Center, New York,  New York,  10003,  United States; Recruiting
David Clain  212-420-4034    dlatorre@chpnet.org 
Dave Latorre  212-420-4034    dlatorre@chpnet.org 
David Clain,  Principal Investigator

      New York Medical College, Valhalla,  New York,  10595,  United States; Recruiting
Edward Lebovics  914-493-7337    ana_casellas@nymc.edu 
Ana Casellas  914-594-3439    ana_casellas@nymc.edu 
Edward Lebovics,  Principal Investigator

      Huntington Medical Group, Huntington,  New York,  11746,  United States; Recruiting
Myron Tong  626-397-5820    unknown 

      Mount Sinai Medical Center, New York,  New York,  10029,  United States; Recruiting
Efsevia Albanis  212-241-0034    debora.goldman@msnyuhealth.org 
Debora Goldman  212-241-2060    debora.goldman@msnyuhealth.org 
Efsevia Albanis,  Principal Investigator

      Columbia Presbyterian Medical Center, New York,  New York,  10032,  United States; Recruiting
Robert Brown  212-305-0662    kcm2103@columbia.edu 
Kate McLean  212-305-3839    kcm2103@columbia.edu 
Robert Brown,  Principal Investigator

North Carolina
      Duke University Medical School, Durham,  North Carolina,  27710,  United States; Recruiting
John McHutchison  919-668-7177    bixby001@mc.duke.edu 
Patricia Bixby  919-681-6819    bixby001@mc.duke.edu 
John McHutchison,  Principal Investigator

      Carolina Center for Liver Disease, Charlotte,  North Carolina,  28203,  United States; Recruiting
Robert Reindollar  704-378-4371    hroberts@ccldhepatology.com 
Heather Roberts  704-524-5478  Ext. 108    hroberts@ccldhepatology.com 
Robert Reindollar,  Principal Investigator

Ohio
      University of Cincinnati, Cincinnati,  Ohio,  45267,  United States; Recruiting
Kenneth Sherman  513-558-7200    unknown 
Susan Sibert  513-584-2363    unknown 
Kenneth Sherman,  Principal Investigator

      Summa Health System, Akron,  Ohio,  44304,  United States; Recruiting
Hector Bonilla  330-375-3894    unknown 
Hector Bonilla,  Principal Investigator

      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States; Recruiting
Anthony Post  216-844-5387    madeleine.murphy@uhhs.com 
Madeleine Murphy  216-844-5379    madeleine.murphy@uhhs.com 
Anthony Post,  Principal Investigator

Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97201,  United States; Recruiting
Atif Zaman  503-494-8577    rutledgr@ohsu.edu 
Renee Rutledge  503-494-0876    rutledgr@ohsu.edu 
Atif Zaman,  Principal Investigator

Pennsylvania
      Regional Gastroenterology Associates of Lancaster, Lancaster,  Pennsylvania,  17603,  United States; Recruiting
Alexandra Gibas  717-544-3400    porter@rgal.com 
Margaret Porter  717-544-3404    porter@rgal.com 
Alexandra Gibas,  Principal Investigator

      Thomas Jefferson University, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
Steven Herrine  215-955-5247    unknown 
Deborah Moretti  215-955-5247    unknown 
Steven Herrine,  Principal Investigator

      Pennsylvania Hospital, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
Frederick Nunes  215-829-3561    unknown 
Frederick Nunes,  Principal Investigator

      Penn State University Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States; Recruiting
Thomas McGarrity  717-531-3834    lpeiffer@psu.edu 
Laurie Peiffer  (717) 531-8259    lpeiffer@psu.edu 
Thomas McGarrity,  Principal Investigator

      Temple University Hospital, Philadelphia,  Pennsylvania,  19140,  United States; Recruiting
Martin Black  215-707-3434    unknown 
Monika Burke  215-707-3434    unknown 
Martin Black,  Principal Investigator

      Albert Einstein Medical Center, Philadelphia,  Pennsylvania,  19141,  United States; Recruiting
Santiago Munoz  215-456-3376    jakemand@einstein.edu 
Donna McGill  215-456-3376    jakemand@einstein.edu 
Santiago Munoz,  Principal Investigator

      University of Pittsburgh Medical Center, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Mordechai Rabinovitz  412-802-3158    unknown 
Trudy Cross  412-802-3158    unknown 
Mordechai Rabinovitz,  Principal Investigator

      Drexel University College of Medicine, Philadelphia,  Pennsylvania,  19103,  United States; Recruiting
Gillian Zeldin  215-762-3900    unknown 
Tammy McKay  215-762-3900    unknown 
Gillian Zeldin,  Principal Investigator

Rhode Island
      University Gastroenterology, Providence,  Rhode Island,  02905,  United States; Recruiting
Thomas Sepe  401-421-8800    unknown 
Brandie Milovitsch  401-421-8800    unknown 
Thomas Sepe,  Principal Investigator

South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting
Adrian Reuben  843-792-6901    unknown 
Nancy Huntley  843-792-6901    unknown 
Adrian Reuben,  Principal Investigator

Tennessee
      Premier Quality Research Consultants, Nashville,  Tennessee,  37211,  United States; Recruiting
Robert Herring  615-832-5530    unknown 
Cindy Drolsum  615-832-5530    unknown 
Robert Herring,  Principal Investigator

Texas
      The Liver Institute at Methodist Dallas, Dallas,  Texas,  75208,  United States; Recruiting
Reem Ghalib  214-947-4400    devinholt@mhd.com 
Devin Holt  214-947-4419    devinholt@mhd.com 
Reem Ghalib,  Principal Investigator

      Alamo Medical Research, San Antonio,  Texas,  78215,  United States; Recruiting
Eric Lawitz  210-253-3422    mfrance@alamomedicalresearch.com 
Michael France  210-253-3422    mfrance@alamomedicalresearch.com 
Eric Lawitz,  Principal Investigator

      University of Texas, Dallas,  Texas,  75390,  United States; Recruiting
William Lee  214-648-3323    Rivka.Elbein@UTSouthwestern.edu 
Rivka Elbein  214-648-4811    Rivka.Elbein@UTSouthwestern.edu 
William Lee,  Principal Investigator

      Liver Specialists of Texas, P.A., Houston,  Texas,  77030,  United States; Recruiting
Joseph Galati  713-794-0700    lstwen@sbcglobal.net 
Wen Tung  713-794-0700    lstwen@sbcglobal.net 
Joseph Galati,  Principal Investigator

      Kelsey-Seybold Clinic, Houston,  Texas,  77025,  United States; Recruiting
Greg Wayne Galler  713-442-0362    jsmarvel@kelsey-seybold.com 
Jennifer Marel  713-442-1212    jsmarvel@kelsey-seybold.com 
Greg Wayne Galler,  Principal Investigator

Utah
      Mountain West Gastroenterology, Salt Lake City,  Utah,  84121,  United States; Recruiting
Terry Box  801-944-3165    unknown 
Amanda McCaffrey  801-944-3165    unknown 
Terry Box,  Principal Investigator

Vermont
      University Of Vermont, Burlington,  Vermont,  05405,  United States; Recruiting
Edward Krawitt  802-897-8215    unknown 
Mary Ann Ray  802-847-8215    unknown 
Edward Krawitt,  Principal Investigator

Virginia
      University of Virginia, Dept. of GI/Hepatology, Charlottesville,  Virginia,  22908,  United States; Terminated

      Mount Vernon Endoscopy Center, Alexandria,  Virginia,  22306,  United States; Recruiting
Jonathan McCone  703-780-0994    unknown 
Bonnie McCone  703-780-0994    unknown 
Jonathan McCone,  Principal Investigator

      Digestive & Liver Disease Specialists, Norfolk,  Virginia,  23502,  United States; Recruiting
Michael Ryan  757-466-0165    beckym@dlds.org 
Rebecca Mosconi  757-466-0165  Ext. 29    beckym@dlds.org 
Michael Ryan,  Principal Investigator

      Medical College Of Virginia, Richmond,  Virginia,  23298,  United States; Recruiting
Mitchell Shiffman  804-828-4060    Carolyn.Frey@med.va.gov 
Carolyn Frey  804 828 9163    Carolyn.Frey@med.va.gov 
Mitchell Shiffman,  Principal Investigator

      Kaiser Permanente Medical Center, Falls Church,  Virginia,  22046,  United States; Recruiting
ROBERT SJOGREN  703-237-4442    sally.j.makay@kp.org 
Sally Makay  703-531-1661    sally.j.makay@kp.org 
Robert Sjogren,  Principal Investigator

Wisconsin
      Dean Medical Center, Madison,  Wisconsin,  53715,  United States; Recruiting
James Levin  608-252-8020    leana.guelzow@deancare.com 
Leana Guelzow  608-252-7406    leana.guelzow@deancare.com 
James Levin,  Principal Investigator

      Froedtert Memorial Lutheran Hospital, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
Jose Franco  414-456-6850    sthierf@mcw.edu 
Sheila Thierfelder  414-259-3823    sthierf@mcw.edu 
Jose Franco,  Principal Investigator

      University of Wisconsin Hospital and Clinics, Madison,  Wisconsin,  53792-5124,  United States; Recruiting
Michael Lucey  608-263-7322    kmm@medicine.wisc.edu 
Kathy Massoth  608-263-4185    kmm@medicine.wisc.edu 
Michael Lucey,  Principal Investigator

More Information

http://www.idealstudy.com

Study ID Numbers:  P03471; 2552898
Record last reviewed:  March 2005
Last Updated:  March 31, 2005
Record first received:  April 20, 2004
ClinicalTrials.gov Identifier:  NCT00081770
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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