The objective of this study is to compare the efficacy of the combination of standard dose Pegasys and Copegus given for 72 weeks (including a 12-week high dose induction) versus the standard doses of Pegasys and Copegus given for 48 weeks in patients that did not respond to previous treatment with PEG-Intron in combination with Rebetol/Ribavirin.

Condition	Treatment or Intervention	Phase
Hepatitis	Drug: Pegylated Interferon alfa-2a in combination with Ribavirin	Phase IV

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age >= 18 years
• Infected with Hepatitis C virus
• Non-responders to previous therapy with PEG-Intron in combination with Rebetol/Ribavirin given for at least 12 weeks
• Termination of PEG-Intron/Rebetol at least 12 weeks prior to enrollment in study

Exclusion Criteria:

• Pregnant, breast-feeding or male partners of those who are pregnant
• Patients who were discontinued from previous PEG-Intron/Rebetol treatment due to hematological (blood) adverse events

Alabama
      Mobile,  Alabama,  36693,  United States
Arizona
      Phoenix,  Arizona,  85054,  United States
California
      San Diego,  California,  92123,  United States
      Ukiah,  California,  95482,  United States
      Pasadena,  California,  91105,  United States
      Long Beach,  California,  90822,  United States
      Los Angeles,  California,  90033,  United States
Connecticut
      Farmington,  Connecticut,  06030,  United States
Florida
      Bradenton,  Florida,  34205,  United States
      Hollywood,  Florida,  33021,  United States
      Jacksonville,  Florida,  32256,  United States
Georgia
      Atlanta,  Georgia,  30308,  United States
      Atlanta,  Georgia,  30309,  United States
      Savannah,  Georgia,  31404,  United States
Illinois
      Chicago,  Illinois,  60612,  United States
      Evanston,  Illinois,  60208,  United States
Iowa
      Des Moines,  Iowa,  50312,  United States
Maryland
      Baltimore,  Maryland,  21205,  United States
      Baltimore,  Maryland,  21201,  United States
Massachusetts
      Boston,  Massachusetts,  02114,  United States
      Boston,  Massachusetts,  02115,  United States
Minnesota
      Rochester,  Minnesota,  55905,  United States
      Plymouth,  Minnesota,  55446,  United States
Missouri
      Kansas City,  Missouri,  64131,  United States
      St. Louis,  Missouri,  63110,  United States
      St. Louis,  Missouri,  63110,  United States
New Jersey
      Florham Park,  New Jersey,  07932,  United States
New Mexico
      Albuquerque,  New Mexico,  87131,  United States
Ohio
      Cleveland,  Ohio,  44195,  United States
Pennsylvania
      Philadelphia,  Pennsylvania,  19104,  United States
      Lancaster,  Pennsylvania,  17604,  United States
Rhode Island
      Cranston,  Rhode Island,  02920,  United States
Tennessee
      Nashville,  Tennessee,  37211,  United States
      Memphis,  Tennessee,  38120,  United States
Texas
      Houston,  Texas,  77054,  United States
Utah
      Salt Lake City,  Utah,  84121,  United States
Vermont
      Burlington,  Vermont,  05401,  United States
Virginia
      Richmond,  Virginia,  23298,  United States
Washington
      Bellevue,  Washington,  98004,  United States

Study ID Numbers:  MV17150
Record last reviewed:  April 2005
Last Updated:  April 6, 2005
Record first received:  July 12, 2004
ClinicalTrials.gov Identifier:  NCT00087646
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08