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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00239733
First received: October 13, 2005
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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
Thrombocytopenia
Hepatitis C
HIV Infections
Drug: Anti-D

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Frequency and severity of adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Absolute change in platelet count from baseline [ Time Frame: Through Week 12 ] [ Designated as safety issue: No ]

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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239733

Contacts
Contact: Kristen M. Marks, MD 212-746-7187 markskr@med.cornell.edu

Locations
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         
Sponsors and Collaborators
Investigators
Principal Investigator: Kristen M. Marks, MD Weill Medical College of Cornell University
  More Information

Additional Information:
Publications:
Responsible Party: Kristen M. Marks, MD, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00239733     History of Changes
Other Study ID Numbers: K23AI65319-01
Study First Received: October 13, 2005
Last Updated: September 25, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV
HCV
Hepatitis C
Thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Infection
Communicable Diseases
Hepatitis
Hepatitis A
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Flaviviridae Infections
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014