Thrombocytopenia | Anti-D for Treating Thrombocytopenia in Adults Infected With Hepatitis C Virus With or Without HIV Co-Infection
Thrombocytopenia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Anti-D30-minute infusion administered in an outpatient setting
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.
Start Date: March 2005
Completed Date: February 2010
Phase: Phase 4
Primary Outcome: Frequency and Severity of Adverse Events
Study sponsors, principal investigator, and references
Principal Investigator: Kristen M. Marks, MD
Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Ware RE, Zimmerman SA. Anti-D: mechanisms of action. Semin Hematol. 1998 Jan;35(1 Suppl 1):14-22. Review.