Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00239733
Status:
TERMINATED
Last Update Posted:
2017-05-16
First Post:
2005-10-13
Brief Title:
Anti-D for Treating Thrombocytopenia in Adults Infected With Hepatitis C Virus With or Without HIV Co-Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
failure to enroll additional subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Thrombocytopenia occurs when a persons 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
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 50000 cellsmicroL 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
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 50000 cellsmicroL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None