MedTrace Logo

Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM2)

NCT01023035 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 687

Last updated 2021-02-08

Study results available
· View outcomes & findings →

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

  • Hepatitis C, Chronic

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-07
Primary Completion
2011-10-26
Completion
2011-10-26

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01023035 on ClinicalTrials.gov