Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043 AM3) - Full Text View

Purpose

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (peg-IFN alfa-2b) and ribavirin (RBV) versus treatment with peg-IFN alfa-2b and RBV alone in Japanese treatment-naïve participants with chronic hepatitis C (CHC) genotype (GT)1.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: vaniprevir Drug: Placebo to vaniprevir Biological: peg-IFN alfa-2b Drug: ribavirin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase III Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Japanese Treatment-Naïve Patients With Chronic Hepatitis C Infection

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin Interferon Alfa-2a Interferon Alfa-2b Peginterferon Alfa-2b

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Proportion of patients achieving sustained virologic response (SVR)24 [ Time Frame: 24 weeks after 24 or 48 weeks of study therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients achieving SVR12 [ Time Frame: 12 weeks after 24 or 48 weeks of study therapy ] [ Designated as safety issue: No ]
Proportion of participants achieving rapid virologic response (RVR) [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
Proportion of participants achieving complete early virologic response (cEVR) [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
Proportion of participants achieving undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (EOT) [ Time Frame: At Week 24 or 48 ] [ Designated as safety issue: No ]

Estimated Enrollment:	285
Study Start Date:	June 2011
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vaniprevir 12 Week Arm Participants on this arm receive 12 weeks of vaniprevir and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN alfa-2b and RBV	Drug: vaniprevir Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 weeks Other Name: MK-7009 Drug: Placebo to vaniprevir Placebo to vaniprevir, capsules, orally, bid for 12 weeks or 24 weeks Biological: peg-IFN alfa-2b peg-IFN α-2b 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks Other Name: PegIntron Drug: ribavirin Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight, for 24 or 48 weeks Other Name: REBETOL®
Experimental: Vaniprevir 24 Week Arm Participants on this arm receive 24 weeks of vaniprevir along with 24 weeks of treatment with peg-IFN alfa-2b and RBV	Drug: vaniprevir Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 24 weeks Biological: peg-IFN alfa-2b peg-IFN α-2b 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks Other Name: PegIntron Drug: ribavirin Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight, for 24 or 48 weeks Other Name: REBETOL®
Active Comparator: Control Arm Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN alfa-2b and RBV	Drug: Placebo to vaniprevir Placebo to vaniprevir, capsules, orally, bid for 12 weeks or 24 weeks Biological: peg-IFN alfa-2b peg-IFN α-2b 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks Other Name: PegIntron Drug: ribavirin Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight, for 24 or 48 weeks Other Name: REBETOL®

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Japanese participant diagnosed with compensated CHC GT 1
Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
IFN treatment naive
No evidence of cirrhosis

Exclusion criteria:

Co-infection with human immunodeficiency virus (HIV)
Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
Any other condition that is contraindicated or for which caution is required for treatment with peg IFN alfa-2b or RBV
Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg IFN alfa-2b and RBV, to the patient.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01370642 History of Changes
Other Study ID Numbers:	MK-7009-043
Study First Received:	June 8, 2011
Last Updated:	May 24, 2012
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

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
Interferon Alfa-2a
Interferon-alpha

Interferon Alfa-2b
Ribavirin
Peginterferon alfa-2b
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors

ClinicalTrials.gov processed this record on June 17, 2013