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

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ClinicalTrials.gov Identifier: NCT00239733
Recruitment Status : Terminated (failure to enroll additional subjects)
First Posted : October 17, 2005
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Kristen Marks, National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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. 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 or disease Intervention/treatment Phase
Thrombocytopenia Hepatitis C HIV Infections Drug: Anti-D Phase 4

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2005
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
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.
 Drug: Anti-D
30-minute infusion administered in an outpatient setting
Other Name: WinRho


Outcome Measures
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Primary Outcome Measures :
  1. Frequency and Severity of Adverse Events [ Time Frame: Throughout study, for up to 12 weeks ]
  2. Absolute Change in Platelet Count From Baseline [ Time Frame: Through Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239733


Locations
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United States, New York
New York Presbyterian Hospital (Cornell)
New York, New York, United States, 10021
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Kristen M. Marks, MD Weill Medical College of Cornell University
More Information
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Publications:

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Responsible Party: Kristen Marks, Assistant Professor, National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00239733    
Other Study ID Numbers: K23AI065319-01 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2005    Key Record Dates
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kristen Marks, National Institute of Allergy and Infectious Diseases (NIAID):
HIV
HCV
Hepatitis C
Thrombocytopenia
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis
Thrombocytopenia
Disease Attributes
Pathologic Processes
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Flaviviridae Infections
Blood Platelet Disorders
Hematologic Diseases