Not Signed In -
Idiopathic Thrombocytopenia Purpura |
ITP |
Clinical Trial: SB497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo in Adults with Refractory Immune Thrombocytopenic Purpura
This study is currently recruiting patients.
|
Purpose
SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 as a treatment for patients with ITP (immune thrombocytopenic purpura) who have failed prior therapy. Following identification of the optimal dose, the study will randomize 150 additional patients to either SB497115 or placebo (for every 2 patients who receive SB497115, 1 patient will receive placebo). The study is designed to determine the proportion of patients with a platelet count greater than or equal to 50,000 platelets/microliter after 42 days.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Purpura, Thrombocytopenic, Idiopathic | Drug: SB497115 | Phase II Phase III |
MedlinePlus related topics: Autoimmune Diseases; Bleeding Disorders; Blood and Blood Disorders; Immune System and Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion criteria:
- Written informed consent
- At least 18 years old
- Chronic low platelet count (less than 30,000 platelets/microliter) for 6 months.
- Failed at least one treatment for chronic low platelet count.
- Patients receiving chronic maintenance steroid therapy must have received a stable dose for at least 1 month.
- No history of heart attack or abnormal heart function.
- No history of clotting disorder, normal prothrombin time (PT) and activated partial thromboplastin time (aPTT).
- Use of acceptable contraceptives.
Exclusion criteria:
- History of thrombosis within 1 year.
- Females who are pregnant.
- Females receiving hormone replacement therapy or systemic contraceptives.
- History of alcohol/drug abuse or dependence within 1 year of starting the study.
- Treatment with an investigational drug within 30 days of starting the study.
- Use of aspirin, aspirin-containing compounds, salicylates, milk of magnesia, non-steroidal anti-inflammatory drugs during the study and within 3 weeks prior to starting the study.
- Use of herbal/dietary supplements (excluding vitamins and mineral supplements) within 1 week of study start.
- Abnormal laboratory values (other than platelet count).
- History of platelet aggregation that would prevent measurement of platelet counts.
- History of HIV infection; active infection with Hepatitis B or C.
Location and Contact Information
Arizona
Tucson, Arizona, 85715, United States; Not yet recruiting
Study Coordinator 520-290-2510
California
Los Angeles, California, 90033, United States; Not yet recruiting
Study Coordinator 323-865-3928
Los Angeles, California, 90995, United States; Not yet recruiting
Study Coordinator 310-794-6892
Colorado
Colorado Springs, Colorado, 80907, United States; Not yet recruiting
Study Coordinator 719-444-4807
Florida
Boca Raton, Florida, 33428, United States; Not yet recruiting
Study Coordinator 561-883-7503
Ocala, Florida, 34474, United States; Recruiting
Study Coordinator 352-732-4938
Georgia
Tucker, Georgia, 30084, United States; Not yet recruiting
Study Coordinator 770-496-9403
Illinois
Chicago, Illinois, 60612, United States; Not yet recruiting
Study Coordinator 312-413-8750
Louisiana
New Orleans, Louisiana, 70115, United States; Not yet recruiting
Study Coordinator 504-894-7115 Ext. 221
Maryland
Baltimore, Maryland, 21205, United States; Not yet recruiting
Study Coordinator 410-502-0033
Michigan
Grosse Pointe Woods, Michigan, 48236, United States; Not yet recruiting
Study Coordinator 313-884-5522
Minnesota
Minneapolis, Minnesota, 55455, United States; Not yet recruiting
Study Coordinator 612-624-6692
Missouri
St. Louis, Missouri, 63110, United States; Not yet recruiting
Study Coordinator 314-362-9270
Jefferson City, Missouri, 65109, United States; Not yet recruiting
Study Coordinator 573-442-6800
Nebraska
Omaha, Nebraska, 68114, United States; Not yet recruiting
Study Coordinator 402-354-5144
Nevada
Las Vegas, Nevada, 89102, United States; Not yet recruiting
Study Coordinator 702-471-7779
New Mexico
Albuquerque, New Mexico, 87109, United States; Not yet recruiting
Study Coordinator 505-243-4039
Santa Fe, New Mexico, 87505, United States; Not yet recruiting
Study Coordinator 505-955-7910
New York
New York, New York, 10021, United States; Not yet recruiting
Study Coordinator 212-746-3474
Rochester, New York, 14642, United States; Not yet recruiting
Study Coordinator 585-275-2224
North Carolina
Cary, North Carolina, 27511, United States; Not yet recruiting
Study Coordinator 919-785-4908
Durham, North Carolina, 27710, United States; Not yet recruiting
Study Coordinator 919-681-9564
Ohio
Cleveland, Ohio, 44195, United States; Not yet recruiting
Study Coordinator 216-444-6823
Pennsylvania
Philadelphia, Pennsylvania, 19104, United States; Not yet recruiting
Study Coordinator 215-662-8848
Texas
Temple, Texas, 76508, United States; Not yet recruiting
Study Coordinator 254-724-4206
Utah
Salt Lake City, Utah, 84106, United States; Not yet recruiting
Study Coordinator 801-269-0231
Virginia
Richmond, Virginia, 23230, United States; Not yet recruiting
Study Coordinator 804-288-7159
France
Lille Cedex, 59037, France; Not yet recruiting
Study Coordinator 011-33 3 20 44 42 95
Strasbourg Cedex, 67091, France; Not yet recruiting
Study Coordinator 011-33 3 88 11 50 66
Paris, 75743, France; Not yet recruiting
Study Coordinator 011-33 1 44 49 52 82
Suresnes, 92150, France; Not yet recruiting
Study Coordinator 011-33 1 46 25 23 08
Bondy Cedex, 93143, France; Not yet recruiting
Study Coordinator 011-33 1 48 02 63 96
Creteil cedex, 94010, France; Not yet recruiting
Study Coordinator 011-33 1 49 81 29 00
Hungary
Budapest, 01125, Hungary; Not yet recruiting
Study Coordinator 011-36(1)3551122
Budapest, 01135, Hungary; Not yet recruiting
Study Coordinator 011-36(1)3504760
Debrecon, 04012, Hungary; Not yet recruiting
Study Coordinator 011-36(5)2432281
Szeged, 06720, Hungary; Not yet recruiting
Study Coordinator 011-36(6)2545226
Pecs, 07624, Hungary; Not yet recruiting
Study Coordinator 011-36(7)2536449
Gyor, 09024, Hungary; Not yet recruiting
Study Coordinator 011-36(9)6507944
Miskolc, H-3501, Hungary; Not yet recruiting
Study Coordinator 011-
Korea, Republic of
Seoul, 136-705, Korea, Republic of; Not yet recruiting
Study Coordinator 011-82 2 920-5488
Seoul, 138-736, Korea, Republic of; Not yet recruiting
Study Coordinator 011-82 2 30103218
Seoul, 140-743, Korea, Republic of; Not yet recruiting
Study Coordinator 011-82 (2) 7099114
Mexico
Mexico, 01090, Mexico; Not yet recruiting
Study Coordinator 011-52(55)506422 Ext. 27305
Mexico, 06720, Mexico; Not yet recruiting
Study Coordinator 011-52 (55) 56276900
Mexico, 06726, Mexico; Not yet recruiting
Study Coordinator 011-52(55)56276900 Ext. 21803
Netherlands
Leiden, 2333 ZA, Netherlands; Not yet recruiting
Study Coordinator 011-31(71)5685054
Nijmegen, 6525 GA, Netherlands; Not yet recruiting
Study Coordinator 011-31(24)3668143
Poland
Bialystok, 15-276, Poland; Not yet recruiting
Study Coordinator 011-
Lublin, 20-954, Poland; Not yet recruiting
Study Coordinator 011-48(81)7244701
Szczecin, 71-242, Poland; Not yet recruiting
Study Coordinator 011-48(91)4253347
Lodz, 93-510, Poland; Not yet recruiting
Study Coordinator 011-48(42)6895191
Russian Federation
Moscow, 105229, Russian Federation; Not yet recruiting
Study Coordinator 011-7 (095) 2630739
Moscow, 125167, Russian Federation; Not yet recruiting
Study Coordinator 011-7(095)2124402
Moscow, 125167, Russian Federation; Not yet recruiting
Study Coordinator 011-7(095)2125571
Moscow, 129110, Russian Federation; Not yet recruiting
Study Coordinator 011-7 (095) 6310573
St Petersburg, 193024, Russian Federation; Not yet recruiting
Study Coordinator 011-7 (812) 2775857
United Kingdom
London, E1 1BB, United Kingdom; Not yet recruiting
Study Coordinator 011-44(0)207 377717
More Information
Study ID Numbers: TRA100773
Record last reviewed: February 2005
Last Updated: February 1, 2005
Record first received: February 1, 2005
ClinicalTrials.gov Identifier: NCT00102739
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: February 2005
Last Updated: February 1, 2005
Record first received: February 1, 2005
ClinicalTrials.gov Identifier: NCT00102739
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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