Cingles Info

Anti-D for Treating Thrombocytopenia in Adults Infected With Hepatitis C Virus
With or Without HIV Co-Infection
This study is currently recruiting patients.
Verified by National Institute of Allergy and Infectious Diseases (NIAID)
December 2005
Sponsored by: National Institute of Allergy and Infectious Diseases
(NIAID)
Information provided by: National Institute of Allergy and
Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00239733
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
MedlinePlus related topics: AIDS; Bleeding Disorders; Hepatitis C
Genetics Home Reference related topics: Bleeding Disorders
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
Further study details as provided by National Institute of Allergy and
Infectious Diseases (NIAID):
Primary Outcomes: Frequency and severity of adverse events; Absolute change in
platelet count from baseline to Weeks 1, 4, and 12 after initiating treatment
Expected Total Enrollment: 20
Study start: March 2005
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 above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria for All Participants:
a.. HCV infected
b.. Currently on treatment for HCV OR plan to begin treatment for HCV at the
start of this study
c.. Platelet count less than 50,000 cells/microl
d.. Hemoglobin greater than 10 g/dl OR greater than 11 g/dl if peginterferon
treatment-naive
e.. Red blood cells are Rh (D) antigen-positive
f.. Negative Coombs direct antibody test
Inclusion Criteria for HIV Infected Group:
a.. HIV infected
Inclusion Criteria for HIV Uninfected Group:
a.. HIV uninfected
Exclusion Criteria:
a.. Prior treatment with intravenous immunoglobulin (IVIG), anti-D, or other
medication for the treatment of thrombocytopenia within 30 days of study entry
b.. Prior serious reaction to plasma products
c.. Absence of spleen
d.. Evidence of thrombotic thrombocytopenic purpura (TTP) OR cause of
thrombocytopenia other than HCV infection, HCV treatment, or HIV infection
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00239733
Kristen M. Marks, MD 212-746-7187 markskr@...
New York
New York Presbyterian Hospital (Cornell), New York, New York, 10021,
United States; Recruiting
Kristen M. Marks, MD 212-746-7187 markskr@...
Kristen M. Marks, MD, Principal Investigator
James Bussel, MD, Sub-Investigator
Andrew Talal, MD, MPH, Sub-Investigator
Marshall Glesby, MD, PhD, Sub-Investigator
Roy (Trip) Gulick, MD, MPH, Sub-Investigator
Study chairs or principal investigators
Kristen M. Marks, MD, Principal Investigator, Weill Medical College of Cornell
University
More Information
Click here for more information about peginterferon alfa-2
Click here for more information about ribavirin
Publications
Ware RE, Zimmerman SA. Anti-D: mechanisms of action. Semin Hematol. 1998
Jan;35(1 Suppl 1):14-22. Review.
Study ID Numbers: K23AI65319-01; K23AI65319-01
Last Updated: December 6, 2005
Record first received: October 13, 2005
ClinicalTrials.gov Identifier: NCT00239733
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-04-03
http://www.clinicaltrials.gov/ct/show/NCT00239733