Anti-D for Treating Thrombocytopenia in Adults Infected With Hepatitis C Virus With or Without HIV Co-Infection

• Status: Terminated
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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. Thrombocytopenia commonly occurs with hepatitis C virus (HCV) infection or as a result of standard HCV treatment. Anti-D is an antibody approved by the Food and Drug Administration (FDA) for the treatment of HIV-related thrombocytopenia. The purpose of this study is to determine the safety and effectiveness of intravenous anti-D for the treatment of thrombocytopenia in patients with HCV infection who are starting or already undergoing treatment with peginterferon alfa-2 and ribavirin. This study will recruit HCV patients both with and without HIV co-infection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

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