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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by (Responsible Party): | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT01023035 |
Purpose
The current trial is designed to prospectively explore the safety of erythropoietin use for the treatment of anemia during boceprevir plus 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).
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: Boceprevir Drug: Peginterferon alfa-2b (Peg2b) Drug: Ribavirin (RBV) Drug: Erythropoietin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/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: | 687 |
| Study Start Date: | December 2009 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pending Randomization Arm
All participants will begin treatment in the Pending Randomization Arm and will be treated with 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV. Participants will continue in the Pending Randomization Arm if their serum hemoglobin remains >10 g/dL throughout the 28- or 48-week treatment period.
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Drug: Boceprevir
800 mg given three times a day (TID), orally (PO)
Other Name: SCH 503034
Drug: Peginterferon alfa-2b (Peg2b)
1.5 µg/kg/week given subcutaneously (SC)
Other Name: SCH 54031
Drug: Ribavirin (RBV)
Ribavirin weight-based dosing (WBD), 600 to 1400 mg/day given twice daily (BID), orally (PO)
Other Name: SCH 18908, Rebetol
|
|
Experimental: Ribavirin Dose Reduction
Participants who become anemic (serum hemoglobin of approximately ≤10 g/dL) within the 28- or 48-week treatment period will be randomized to the ribavirin (RBV) dose reduction arm or the erythropoietin use arm for management of the anemia.
|
Drug: Boceprevir
800 mg given three times a day (TID), orally (PO)
Other Name: SCH 503034
Drug: Peginterferon alfa-2b (Peg2b)
1.5 µg/kg/week given subcutaneously (SC)
Other Name: SCH 54031
Drug: Ribavirin (RBV)
Ribavirin weight-based dosing (WBD), 600 to 1400 mg/day given twice daily (BID), orally (PO)
Other Name: SCH 18908, Rebetol
|
|
Experimental: Erythropoietin Use
Participants who become anemic (serum hemoglobin of approximately ≤10 g/dL) within the 28- or 48-week treatment period will be randomized to the ribavirin (RBV) dose reduction arm or the erythropoietin use arm for management of the anemia.
|
Drug: Boceprevir
800 mg given three times a day (TID), orally (PO)
Other Name: SCH 503034
Drug: Peginterferon alfa-2b (Peg2b)
1.5 µg/kg/week given subcutaneously (SC)
Other Name: SCH 54031
Drug: Ribavirin (RBV)
Ribavirin weight-based dosing (WBD), 600 to 1400 mg/day given twice daily (BID), orally (PO)
Other Name: SCH 18908, Rebetol
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
Other Name: Procrit, Eprex
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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: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT01023035 History of Changes |
| Other Study ID Numbers: | P06086, 2009-012782-63 |
| Study First Received: | November 24, 2009 |
| Last Updated: | November 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Epoetin Alfa |
Ribavirin Peginterferon alfa-2b Interferon-alpha Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |