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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 |
|
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 |