Trials / Completed
CompletedNCT01023035
Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM2)
Boceprevir and Peginterferon/Ribavirin for the Treatment of Chronic Hepatitis C in Treatment-Naive Subjects: A Comparison of Erythropoietin Use Versus Ribavirin Dose Reduction for the Management of Anemia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 687 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The current trial is designed to prospectively explore the safety of erythropoietin use for the treatment of anemia during boceprevir plus peginterferon alfa-2b/Ribavirin (PEG2b/RBV) therapy and to assess its relationship to efficacy. All participants in this trial will be treated with the triple combination of boceprevir plus PEG2b/RBV. If a participant becomes anemic during treatment, the participant will be randomized to one of two therapeutic strategies for management of anemia (erythropoietin use versus RBV dose reduction).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Boceprevir | 800 mg given three times a day (TID), orally (PO) |
| DRUG | Peginterferon alfa-2b (PEG2b) | 1.5 µg/kg/week given subcutaneously (SC) |
| DRUG | Ribavirin (RBV) | Ribavirin weight-based dosing (WBD), 600 to 1400 mg/day given twice daily (BID), orally (PO) |
| DRUG | Erythropoietin | Initial dose of 40,000 Units given subcutaneously (SC) once weekly (QW), with dose adjustment as necessary to achieve and maintain serum hemoglobin levels of 10-12 g/dL |
Timeline
- Start date
- 2009-12-07
- Primary completion
- 2011-10-26
- Completion
- 2011-10-26
- First posted
- 2009-12-01
- Last updated
- 2021-02-08
- Results posted
- 2012-11-15
Source: ClinicalTrials.gov record NCT01023035. Inclusion in this directory is not an endorsement.