A Phase 4 interventional study of Anti-D in Thrombocytopenia, Hepatitis C and HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-16.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 4, Interventional, and Treatment
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.
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.
703 studies on the registry are indexed under Thrombocytopenia; 150 are open to participants now.
This study's enrollment of 6 is below the median of 55 across 475 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,445 studies on the registry; 182 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 300 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for All Participants:
Inclusion Criteria for HIV Infected Group:
Inclusion Criteria for HIV Uninfected Group:
Exclusion Criteria:
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
Also known as: WinRho
Frequency and Severity of Adverse Events
Time frame: Throughout study, for up to 12 weeks
Absolute Change in Platelet Count From Baseline
Time frame: Through Week 12
| Milestone | Anti-D |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
| Participants | Anti-D |
|---|---|
| Any SAE | 3 |
| Post infusion reactions | 2 |
| Hepatic decompensation | 1 |
| Any Hyperbilirubinemia | 6 |
| Gr 3-4 Hyperbilrubinemia | 1 |
| Anemia (all grade 1) | 5 |
| Fatigue | 4 |
| Fever | 2 |
| Dyspnea on exertion | 3 |
| Headache (all grade 1) | 2 |
| Depression (mild) | 1 |
| hypothyroidism | 1 |
| Neutropenia (likely sec to IFN) | 4 |
| Hospitalized | 3 |
| Death | 1 |
| Participants | Anti-D |
|---|---|
| Platelet response >50,000/ul week 1 | 1 |
| Platelet response >50,000/ul week 2 | 2 |
| Platelet response >50,000/ul week 4 | 2 |
| Platelet response >50,000/ul week 8 | 3 |
| Platelet response >50,000/lu week 12 | 0 |
| Tp-related dose interruption peginterferon/ribavir | 1 |
| Anemia-related dose interruption peginterferon | 2 |
| Anemia-related dose interruption ribavirin | 5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anti-D | — | 3/6 (50%) | 6/6 (100%) |
| Event | Anti-D |
|---|---|
| Hepatic decompensationHepatobiliary disorders | 1/6 |
| GastroenteritisGastrointestinal disorders | 1/6 |
| Seixzure/meningitisNervous system disorders | 1/6 |
| Death (sepsis_Infections and infestations | 1/6 |
| Event | Anti-D |
|---|---|
| Anemia Gr 1Blood and lymphatic system disorders | 5/6 |
| Dyspnea on exertionCardiac disorders | 3/6 |
| Post infusion reactionsVascular disorders | 2/6 |
| Hyperbilirubinemia Gr 3-4Hepatobiliary disorders | 1/6 |
| HeadacheNervous system disorders | 1/6 |
| HypothyroidismEndocrine disorders | 1/6 |
| Age, Continuous(years) | Anti-D |
|---|---|
| Median | 51 (32 to 66) |
| Sex: Female, Male(Participants) | Anti-D |
|---|---|
| Female | 1 |
| Male | 5 |
| Region of Enrollment(participants) | Anti-D |
|---|---|
| United States | 6 |
| Other baseline characteristics(Participants) | Anti-D |
|---|---|
| HIV coinfected | 1 |
| Cirrhosis | 5 |
| Decompensated Cirrhosis | 3 |
Plan to share: No
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Studies of the drug tested here: RHO(D) antibody
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