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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00239733 |
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.
Condition | Intervention |
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Thrombocytopenia Hepatitis C HIV Infections |
Drug: Anti-D |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Safety and Efficacy of Intravenous Anti-D for the Treatment of Thrombocytopenia in Patients With HCV Infection Prior to or During Treatment With Pegylated-Interferon and Ribavirin |
Estimated Enrollment: | 20 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants 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.
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Drug: Anti-D
30-minute infusion administered in an outpatient setting
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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 make this treatment less than ideal for patients with HCV. Medications to prevent or treat serious neutropenia and anemia have been established and are commonly used. However, thrombocytopenia remains a barrier to the effective treatment of HCV infection in some patients. Developing a more effective treatment for thrombocytopenia for these patients would decrease the risk of serious bleeding events. It may also improve HCV treatment outcomes by preventing dose modifications or discontinuations of peginterferon alfa-2 and ribavirin due to thrombocytopenia.
Anti-D is an antibody to the Rh (D) antigen on red blood cells. When anti-D attaches to the Rh (D) antigen, immune-mediated destruction of platelets is prevented, helping to alleviate low platelet levels in people with thrombocytopenia. This study will investigate the safety and efficacy of anti-D for the treatment of thrombocytopenia in HCV patients currently on or starting standard HCV treatment. Both HIV infected and uninfected participants will be recruited for this study.
This study will last 12 weeks. Participants in this study must be either currently on peginterferon alfa-2 and ribavirin treatment or initiating such treatment at the start of the study; these two medications will not be provided by the study. At study entry, participants will be given anti-D over a 30-minute infusion 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. Efficacy of anti-D treatment will be assessed by absolute change in platelet count and the ability to sustain plaletet counts greater than 50,000 cells/microL during the study. Cytokine levels will also be monitored to gain insight on how anti-D may work with cytokines in platelet survival and clearance.
Generally, study visits will occur at study entry and Weeks 1, 2, 4, 8, and 12. In patients who require additional infusions of anti-D, there will be additional visits scheduled for each additional infusion and a postinfusion visit occurring 1 week after each infusion. All study visits will include medication history and blood collection. A clinical assessment and a targeted physical exam will occur at study entry, Weeks 1 and 12, and at additional infusion and postinfusion visits, if applicable.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for All Participants:
Inclusion Criteria for HIV Infected Group:
Inclusion Criteria for HIV Uninfected Group:
Exclusion Criteria:
Contact: Kristen M. Marks, MD | 212-746-7187 | markskr@med.cornell.edu |
United States, New York | |
New York Presbyterian Hospital (Cornell) | Recruiting |
New York, New York, United States, 10021 | |
Contact: Kristen M. Marks, MD 212-746-7187 markskr@med.cornell.edu | |
Principal Investigator: Kristen M. Marks, MD | |
Sub-Investigator: James Bussel, MD | |
Sub-Investigator: Andrew Talal, MD, MPH | |
Sub-Investigator: Marshall Glesby, MD, PhD | |
Sub-Investigator: Roy (Trip) Gulick, MD, MPH |
Principal Investigator: | Kristen M. Marks, MD | Weill Medical College of Cornell University |
Responsible Party: | Weill Medical College of Cornell University ( Kristen M. Marks, MD ) |
Study ID Numbers: | K23AI65319-01 |
Study First Received: | October 13, 2005 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00239733 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV HCV Hepatitis C Thrombocytopenia |
Sexually Transmitted Diseases, Viral Liver Diseases Hematologic Diseases Blood Platelet Disorders Interferons Ribavirin Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Immunologic Deficiency Syndromes |
Hepatitis Virus Diseases Thrombocytopathy Thrombocytopenia Digestive System Diseases HIV Infections Sexually Transmitted Diseases Hepatitis C Retroviridae Infections |
Communicable Diseases Liver Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Flaviviridae Infections Immune System Diseases Hematologic Diseases Blood Platelet Disorders Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human |
Infection Immunologic Deficiency Syndromes Hepatitis Virus Diseases Digestive System Diseases Thrombocytopenia HIV Infections Sexually Transmitted Diseases Lentivirus Infections Hepatitis C Retroviridae Infections |