Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM2)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Boceprevir; Peginterferon alfa-2b (PEG2b); Ribavirin (RBV); Erythropoietin
Intervention description: 800 mg given three times a day (TID), orally (PO); 1.5 µg/kg/week given subcutaneously (SC); Ribavirin weight-based dosing (WBD), 600 to 1400 mg/day given twice daily (BID), orally (PO); 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
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 687.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

Eligibility 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.