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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: Boceprevir (Drug); Peginterferon alfa-2b (PEG2b) (Drug); Ribavirin (RBV) (Drug); Erythropoietin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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).

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With Sustained Virologic Response (SVR)

Secondary outcome: Percentage of Participants Who Discontinued Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participant must have previously documented Chronic Hepatitis C (CHC) genotype 1

infection.

- Hemoglobin concentration at Screening must be ≤15 g/dL for both females and males.

- Participant must have a liver biopsy with histology consistent with CHC and no other

etiology.

- Participant with bridging fibrosis (F3) or cirrhosis (F4) must have an ultrasound

within 6 months of the Screening Visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma.

- Participant's weight must be ≥40 kg and ≤125 kg.

- Participant and participant's partner(s) must each agree to use acceptable methods of

contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.

- Participant must be willing to give written informed consent.

- Participant must be willing to attend frequent site visits for the duration of the

trial.

- Participant must not have any contraindications for the use of erythropoietin.

Exclusion Criteria:

- Participants known to be coinfected with the human immunodeficiency virus (HIV) or

hepatitis B virus.

- Participants who received prior treatment for hepatitis C.

- Treatment with any investigational drug within 30 days of the screening visit in this

trial.

- Participants receiving any of the following medication(s) within 2 weeks prior to the

Day 1 visit: alfuzosin, antiarrhythmics (amiodarone, bepridil, flecainide, propafenone, and quinidine), ergot derivatives, cisapride, lovastatin, simvastatin, pimozide, triazolam, and orally administered midazolam.

- Participation in any other clinical trial within 30 days of the screening visit in

this trial or intention to participate in another clinical trial during participation in this trial.

- Evidence of decompensated liver disease.

- Diabetic and/or hypertensive participants with clinically significant ocular

examination findings.

- Pre-existing psychiatric condition(s).

- Clinical diagnosis of substance abuse of specified drugs within specified timeframes.

- Any known pre-existing medical condition that could interfere with the participant's

participation in and completion of the trial.

- Evidence of active or suspected malignancy, or a history of malignancy, within the

last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin).

- Participants who are pregnant or nursing. Participants who intend to become pregnant

during the trial period. Male participants with partners who are, or intend to become, pregnant during the trial period.

- Any other condition which, in the opinion of a physician, would make the participant

unsuitable for enrollment or could interfere with the participant participating in and completing the trial.

- Participant who had a life-threatening serious adverse event during the screening

period.

- A participant must not be a member or a family member of the personnel of the

investigational or sponsor staff directly involved with this trial.

- Protocol-specified hematologic, biochemical, and serologic criteria (growth factors

may not be used to achieve trial entry requirements).

- Serum albumin below the lower limit of normal (LLN) of laboratory reference range.

- Thyroid-stimulating hormone (TSH) >1. 2 x Upper Limit of Normal (ULN) or <0. 8 x LLN of

laboratory reference.

- Serum creatinine >ULN of the laboratory reference.

- Protocol-specified serum glucose concentrations.

- Prothrombin time/partial thromboplastin time (PT/PTT) values >10% above laboratory

reference range.

- Protocol-specified alpha fetoprotein concentrations.

Locations and Contacts

Additional Information

Starting date: December 2009
Last updated: November 4, 2014

Page last updated: August 23, 2015

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