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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00880763 |
The study evaluates safety and efficacy of MK7009, when administered with Pegylated-Interferon and Ribavirin, in Japanese patients with Hepatitis C infection.
Condition | Intervention | Phase |
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Hepatitis C |
Drug: MK7009 Drug: Pegylated Interferon Drug: Ribavirin Drug: Comparator: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Randomized Study to Evaluate Safety and Efficacy of MK7009 Administered With Pegylated-Interferon and Ribavirin in Japanese Treatment-Experienced Patients With Chronic Hepatitis C Infection |
Estimated Enrollment: | 120 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
MK7009 (200 mg) + Pegylated Interferon + Ribavirin
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Drug: MK7009
MK7009 Oral , twice daily (200, 600 or 1200 mg/day) for 28 days
Drug: Pegylated Interferon
Pegylated Interferon Subcutaneous injection, 180 micrograms weekly, for 28 days
Drug: Ribavirin
Ribavirin Oral, twice daily, 600 mg/day to 1000 mg /day, for 28 days
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2: Experimental
MK7009 (600 mg) + Pegylated Interferon + Ribavirin
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Drug: MK7009
MK7009 Oral , twice daily (200, 600 or 1200 mg/day) for 28 days
Drug: Pegylated Interferon
Pegylated Interferon Subcutaneous injection, 180 micrograms weekly, for 28 days
Drug: Ribavirin
Ribavirin Oral, twice daily, 600 mg/day to 1000 mg /day, for 28 days
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3: Experimental
MK7009 (1200 mg) + Pegylated Interferon + Ribavirin
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Drug: MK7009
MK7009 Oral , twice daily (200, 600 or 1200 mg/day) for 28 days
Drug: Pegylated Interferon
Pegylated Interferon Subcutaneous injection, 180 micrograms weekly, for 28 days
Drug: Ribavirin
Ribavirin Oral, twice daily, 600 mg/day to 1000 mg /day, for 28 days
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4: Placebo Comparator
Placebo + Pegylated Interferon + Ribavirin
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Drug: Pegylated Interferon
Pegylated Interferon Subcutaneous injection, 180 micrograms weekly, for 28 days
Drug: Ribavirin
Ribavirin Oral, twice daily, 600 mg/day to 1000 mg /day, for 28 days
Drug: Comparator: Placebo
Placebo to MK7009 Oral, twice daily for 28 days
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Ages Eligible for Study: | 20 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2009_576, MK7009-016 |
Study First Received: | April 10, 2009 |
Last Updated: | September 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00880763 History of Changes |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Antimetabolites Anti-Infective Agents Liver Diseases Hepatitis, Chronic Ribavirin Interferons Hepatitis, Viral, Human |
Antiviral Agents Hepatitis Virus Diseases Digestive System Diseases Hepatitis C Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents Liver Diseases RNA Virus Infections Molecular Mechanisms of Pharmacological Action Hepatitis, Chronic Flaviviridae Infections Antineoplastic Agents Interferons Ribavirin |
Hepatitis, Viral, Human Antiviral Agents Pharmacologic Actions Hepatitis Virus Diseases Digestive System Diseases Therapeutic Uses Hepatitis C Hepatitis C, Chronic |