A Study of Safety and Efficacy of MK7009 Administered With Pegylated-Interferon and Ribavirin in Japanese Patients With Chronic Hepatitis C Infection - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00880763

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Interferons

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Proportion of patients achieving viral response [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of MK7009 as assessed by review of the accumulated safety data [ Time Frame: 42 Days ] [ Designated as safety issue: Yes ]

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
1: Experimental MK7009 (200 mg) + Pegylated Interferon + Ribavirin	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
2: Experimental MK7009 (600 mg) + Pegylated Interferon + Ribavirin	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
3: Experimental MK7009 (1200 mg) + Pegylated Interferon + Ribavirin	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
4: Placebo Comparator Placebo + Pegylated Interferon + Ribavirin	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

Eligibility

Ages Eligible for Study:	20 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient Has Chronic Genotype 1 Hepatitis C Infection

Exclusion Criteria:

Patient Has Not Tolerated Previous Course Of Peg-IFN And Ribavirin
Patient Has HIV
Patient Has Hepatitis B
Patient Has A History Of Clinically Significant Medical Condition That May Interfere With The Study (e.g., Stroke Or Chronic Seizures Or Major Neurological Disorder) Or Is Contraindicated For Treatment With Peg-IFN And Ribavirin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880763

Locations

Japan, Chiyodaku
Merck Ltd., Japan	Recruiting
Tokyo, Chiyodaku, Japan, 102-8667
Contact: Tadaaki Taniguchi 81-3-6272-1547

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 04, 2009