CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 687 enrolled
Drug / intervention
Boceprevir +3 moredrug
Likely dose
Boceprevir 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01023035
NCT01023035Phase 3Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Dec 1, 2009·Updated Feb 8, 2021

In Brief

A Phase 3 clinical trial evaluating Boceprevir, Peginterferon alfa-2b (PEG2b), and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 687 participants.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 1, 2009
Enrollment StartDec 7, 2009
Primary CompletionOct 26, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.6 years ago

Interventions

Boceprevirdrug

800 mg given three times a day (TID), orally (PO)

Peginterferon alfa-2b (PEG2b)drug

1.5 µg/kg/week given subcutaneously (SC)

Ribavirin (RBV)drug

Ribavirin weight-based dosing (WBD), 600 to 1400 mg/day given twice daily (BID), orally (PO)

Erythropoietindrug

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