Safety and Efficacy of MK7009 Administered With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00704405

Purpose

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

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Interferons

U.S. FDA Resources

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

Further study details as provided by Merck:

Primary Outcome Measures:

1) Safety and tolerability of MK7009 as assessed by review of accumulated safety data; 2) antiviral activity of 600 mg b.i.d. MK7009 as assessed by proportion of patients achieving SVR24 [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

1) Antiviral activity of 300 mg b.i.d. MK7009 as assessed by proportion of patients achieving SVR24 2) antiviral activity of MK7009 as assessed by proportion of patients achieving undetectable viral RNA at treatment week 12 [ Time Frame: 1) 72 weeks; 2) 12 weeks ] [ Designated as safety issue: No ]

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic Genotype 1 hepatitis C infection
Treatment experienced
No evidence of cirrhosis

Exclusion Criteria:

Has not tolerated previous course of peg-IFN and RBV
Unlikely to tolerate at least 24 weeks of continuous therapy with peg-IFN and RBV
HIV and/or active hepatitis B co-infection
Consumes more than 3 alcoholic beverages a day
Has a history of drug or alcohol abuse
If female, patient is pregnant or breastfeeding
Has been in a clinical trial with an Investigational drug in the last 30 days.
IFN/peg-IFN and RBV use in the last 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704405

Contacts

Contact: Toll Free Number

1-888-577-8839

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

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

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Flaviviridae Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009