Status:
TERMINATED
Anti-D for Treating Thrombocytopenia in Adults Infected With Hepatitis C Virus With or Without HIV Co-Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Thrombocytopenia
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Thrombocytopenia occurs when a person's blood has a decreased number of platelets, which are cells involved in blood clotting. This condition may lead to uncontrolled bleeding and can be fatal. Thromb...
Detailed Description
Peginterferon alfa-2 with ribavirin is the current standard of care for the treatment of HCV infection; however, severe hematologic effects, including anemia, leukopenia, and thrombocytopenia, may mak...
Eligibility Criteria
Inclusion
- Inclusion Criteria for All Participants:
- HCV-infected
- Currently on treatment for HCV OR plan to begin treatment for HCV at the start of this study
- Platelet count less than 50,000 cells/microl
- Hemoglobin greater than 10 g/dl OR greater than 11 g/dl if peginterferon treatment-naive
- Red blood cells are Rh (D) antigen-positive
- Negative Coombs direct antibody test
- Inclusion Criteria for HIV Infected Group:
- HIV-infected
- Inclusion Criteria for HIV Uninfected Group:
- HIV-uninfected
- Exclusion Criteria:
- Prior treatment with intravenous immunoglobulin (IVIG), anti-D, or other medication for the treatment of thrombocytopenia within 30 days of study entry
- Prior serious reaction to plasma products
- Absence of spleen
- Evidence of thrombotic thrombocytopenic purpura (TTP) OR cause of thrombocytopenia other than HCV infection, HCV treatment, or HIV infection
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00239733
Start Date
March 1 2005
End Date
February 1 2010
Last Update
May 16 2017
Active Locations (1)
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1
New York Presbyterian Hospital (Cornell)
New York, New York, United States, 10021