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Sponsored by: |
Merck |
---|---|
Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00704405 |
A study to test the safety, tolerability, and efficacy of 4 regimens of MK7009 + Peg-IFN and RBV as compared to placebo + Peg-IFN and RBV.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis C Virus Infection |
Drug: Comparator: Peg-INF Drug: Comparator: RBV Drug: Comparator: MK7009; Drug: Comparator: Placebo. Drug: Comparator: MK7009. Drug: Comparator: MK7009 Drug: Comparator: Placebo; Drug: Comparator: Peg-INF. Drug: Comparator: RBV. |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Experienced Patients With Chronic Genotype 1 Hepatitis C Virus Infection |
Estimated Enrollment: | 200 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
MK7009 600 mg b.i.d. + peg-IFN + ribavirin (24 weeks)
|
Drug: Comparator: MK7009;
MK7009 600 mg b.i.d.; duration of treatment: 24 weeks.
Drug: Comparator: Peg-INF.
Peg-INF; duration of treatment: 24 weeks
Drug: Comparator: RBV.
RBV; duration of treatment: 24 weeks
|
2: Experimental
MK7009 600 mg b.i.d. + peg-IFN + ribavirin (24 weeks) followed by placebo + peg-IFN + ribavirin (24 weeks)
|
Drug: Comparator: Peg-INF
Peg-INF; duration of treatment: 48 Weeks
Drug: Comparator: RBV
RBV; duration of treatment: 48 Weeks
Drug: Comparator: MK7009;
MK7009 600 mg b.i.d.; duration of treatment: 24 weeks.
Drug: Comparator: Placebo.
Matching placebo to MK7009; duration of treatment: 24 weeks
|
3: Experimental
MK7009 300 mg b.i.d. + peg-IFN + ribavirin (48 weeks)
|
Drug: Comparator: Peg-INF
Peg-INF; duration of treatment: 48 Weeks
Drug: Comparator: RBV
RBV; duration of treatment: 48 Weeks
Drug: Comparator: MK7009.
MK7009 300 mg b.i.d.; duration of treatment: 48 weeks
|
4: Experimental
MK7009 600 mg b.i.d. + peg-IFN + ribavirin (48 weeks)
|
Drug: Comparator: Peg-INF
Peg-INF; duration of treatment: 48 Weeks
Drug: Comparator: RBV
RBV; duration of treatment: 48 Weeks
Drug: Comparator: MK7009
MK7009 600 mg b.i.d.; duration of treatment: 48 weeks
|
5: Placebo Comparator
placebo + peg-IFN + ribavirin (48 weeks)
|
Drug: Comparator: Peg-INF
Peg-INF; duration of treatment: 48 Weeks
Drug: Comparator: RBV
RBV; duration of treatment: 48 Weeks
Drug: Comparator: Placebo;
Matching placebo to MK7009; duration of treatment: 48 weeks
|
Ages Eligible for Study: | 18 Years to 65 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: | 2007_659, MK7009-009 |
Study First Received: | June 23, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00704405 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Interferons Ribavirin Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
Communicable Diseases RNA Virus Infections Flaviviridae Infections Infection |