Study 6 of 10 for search of: boceprevir
Previous Study Return to Search Results Next Study

Full Text View
Tabular View
No Study Results Posted
Related Studies
Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM1)
This study is ongoing, but not recruiting participants.
First Received: November 24, 2009   Last Updated: August 18, 2010   History of Changes
Sponsor: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT01023035
  Purpose

This study involves treatment with boceprevir in combination with PegIntron (PEG2b) + ribavirin (RBV) (weight-based dosing [WBD]) in previously untreated adult subjects with chronic hepatitis C (CHC) genotype 1. All subjects will begin treatment in the Pending Randomization Arm and will be treated with 4 weeks of PEG2b/RBV followed by 44 weeks of boceprevir plus PEG2b/RBV. Subjects will continue in the Pending Randomization Arm if their serum hemoglobin remains >10 g/dL throughout the 48 week treatment period. Subjects who become anemic (serum hemoglobin of approximately <=10 g/dL) within the 48-week treatment period will be randomized to Arm 1 (RBV dose reduction) or Arm 2 (erythropoietin use) for management of the anemia. The total duration of therapy for all subjects will be 48 weeks.

The primary objective of this trial is to compare the effect on efficacy of erythropoietin use versus RBV dose reduction for the management of anemia in subjects who become anemic during the treatment of CHC genotype 1 infection with boceprevir plus PEG2b/RBV therapy. It is suggested that an appropriate anemia management strategy may allow subjects to remain on optimal therapy and increase their ability to achieve SVR


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Boceprevir (SCH 503034)
Drug: erythropoietin
Biological: Peginterferon alfa-2b (SCH 54031)
Drug: Ribavirin (SCH 18908)
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Active Control
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Sustained virologic response (SVR), defined as undetectable plasma HCV-RNA at Follow-up Week 24, after treatment with boceprevir and PegIntron plus ribavirin in previously untreated subjects with chronic hepatitis C genotype 1 [ Time Frame: At Follow-up Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability as defined by the difference in the cumulative discontinuation rates for Arm 1 (ribavirin dose reduction) and Arm 2 (erythropoietin use). [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 685
Study Start Date: December 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pending Randomization Arm: Experimental
All subjects will begin treatment in the Pending Randomization Arm and will be treated with 4 weeks of PEG2b/RBV followed by 44 weeks of boceprevir plus PEG2b/RBV. Subjects will continue in the Pending Randomization Arm if their serum hemoglobin remains >10 g/dL throughout the 48 week treatment period.
Drug: Boceprevir (SCH 503034)
Boceprevir, 200-mg capsules, 800 mg three times a day (TID) orally (PO).
Biological: Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b 1.5 µg/kg/week subcutaneously (SC)
Drug: Ribavirin (SCH 18908)
Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID).
Arm 1 (ribavirin dose reduction): Experimental
Subjects who become anemic (serum hemoglobin of approximately <=10 g/dL) within the 48-week treatment period will be randomized to Arm 1 (RBV dose reduction) or Arm 2 (erythropoietin use) for management of the anemia.
Drug: Boceprevir (SCH 503034)
Boceprevir, 200-mg capsules, 800 mg three times a day (TID) orally (PO).
Biological: Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b 1.5 µg/kg/week subcutaneously (SC)
Drug: Ribavirin (SCH 18908)
Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID).
Arm 2 (erythropoietin use): Experimental
Subjects who become anemic (serum hemoglobin of approximately <=10 g/dL) within the 48-week treatment period will be randomized to Arm 1 (ribavirin dose reduction) or Arm 2 (erythropoietin use) for management of the anemia.
Drug: Boceprevir (SCH 503034)
Boceprevir, 200-mg capsules, 800 mg three times a day (TID) orally (PO).
Drug: erythropoietin
40,000 Units subcutaneously (SC) once weekly (QW).
Biological: Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b 1.5 µg/kg/week subcutaneously (SC)
Drug: Ribavirin (SCH 18908)
Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have previously documented CHC genotype 1 infection.
  • Hemoglobin concentration at Screening must be <=15 g/dL for both females and males.
  • Subject must have a liver biopsy with histology consistent with CHC and no other etiology.
  • Subjects 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.
  • Subject must be >=18 years of age.
  • Subject's weight must be >=40 kg and <=125 kg.
  • Subject and subject'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.
  • Subjects must be willing to give written informed consent.
  • Subjects must be willing to attend frequent site visits for the duration of the trial.
  • Subjects must not have any contraindications for the use of erythropoietin.

Exclusion Criteria:

  • Subjects known to be coinfected with the human immunodeficiency virus (HIV) or hepatitis B virus.
  • Subjects who received prior treatment for hepatitis C.
  • Treatment with any investigational drug within 30 days of the screening visit in this trial.
  • Subjects 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 subjects 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 subject'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).
  • Subjects who are pregnant or nursing. Subjects who intend to become pregnant during the trial period. Male subjects 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 subject unsuitable for enrollment or could interfere with the subject participating in and completing the trial.
  • Subjects who had a life-threatening serious adverse event during the screening period.
  • A subject 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 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp ( Vice President of Late Stage Development )
ClinicalTrials.gov Identifier: NCT01023035     History of Changes
Other Study ID Numbers: P06086, EudraCT No. 2009-012782-63
Study First Received: November 24, 2009
Last Updated: August 18, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Epoetin Alfa
Ribavirin
Peginterferon alfa-2b
Interferon Alfa-2b
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 01, 2010