A Study of Vaniprevir (MK-7009) in Patients With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028 AM4) - Full Text View

Sponsor:	Merck
Information provided by (Responsible Party):	Merck
ClinicalTrials.gov Identifier:	NCT00943761

Purpose

This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon and ribavirin to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: Vaniprevir (600 mg b.i.d.) Drug: Vaniprevir (300 mg b.i.d.) Drug: Pegylated interferon (Peg-IFN) Drug: Ribavirin (RBV)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Open Label Study of MK-7009 Administered Concomitantly With Pegylated Interferon Alfa-2a and Ribavirin to Patients With Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical Trials

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a Hepatitis A Vaccines Interferons

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Number of participants with adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
Number of participants with serious adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
Number of participants achieving sustained viral response 24 weeks after the end of treatment (SVR24) [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	June 2010
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vaniprevir (600 mg b.i.d.) + peg-IFN + RBV	Drug: Vaniprevir (600 mg b.i.d.) Capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks Drug: Pegylated interferon (Peg-IFN) Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks Other Name: PEGASYS™ Drug: Ribavirin (RBV) Tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight, for 48 weeks Other Name: COPEGUS™
Experimental: Vaniprevir (300 mg b.i.d.) + peg-IFN + RBV	Drug: Vaniprevir (300 mg b.i.d.) Capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks Drug: Pegylated interferon (Peg-IFN) Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks Other Name: PEGASYS™ Drug: Ribavirin (RBV) Tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight, for 48 weeks Other Name: COPEGUS™

Arms

Assigned Interventions

Experimental: Vaniprevir (600 mg b.i.d.) + peg-IFN + RBV

Drug: Vaniprevir (600 mg b.i.d.)

Capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks

Drug: Pegylated interferon (Peg-IFN)

Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks

Other Name: PEGASYS™

Drug: Ribavirin (RBV)

Tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight, for 48 weeks

Other Name: COPEGUS™

Experimental: Vaniprevir (300 mg b.i.d.) + peg-IFN + RBV

Drug: Vaniprevir (300 mg b.i.d.)

Capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks

Drug: Pegylated interferon (Peg-IFN)

Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks

Other Name: PEGASYS™

Drug: Ribavirin (RBV)

Tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight, for 48 weeks

Other Name: COPEGUS™

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Participant has participated in a prior vaniprevir clinical trial
Participant agrees to use acceptable birth control method during treatment

Exclusion criteria:

More than one year has passed since the participant was determined to be eligible for enrollment in protocol 028
Participant discontinued vaniprevir and/or peg-IFN and/or RBV in the prior study due to a safety or tolerability issue
Participant received any investigational therapy for HCV after participating in the prior study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943761

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

Australia
Merck Sharp & Dohme (Australia) Pty Ltd.	Recruiting
South Granville, Australia, NSW 2142
Contact: Gary Jankelowitz 61 297959962
Austria
Merck Sharp & Dohme Gmbh	Recruiting
Vienna, Austria, 1220
Contact: Karl Boegl 43126044130
Belgium
Merck Sharp & Dohme B.V.	Recruiting
Bruxelles, Belgium, 1180
Contact: Danny DHulster 3223734310
Chile
Merck Sharp & Dohme (I.A.) Corp.	Recruiting
Santiago, Chile, 6761641
Contact: Maria Elena Azara Hernandez 56 2 6558958
Czech Republic
Merck Sharp & Dohme IDEA Inc.	Recruiting
Praha, Czech Republic, 162 00
Contact: Simona Martinkova 420-233-010-213
France
Laboratoires Merck Sharp & Dohme - Chibret	Recruiting
Paris Cedex 8, France, 75114
Contact: Dominique Blazy 33147548990
Germany
Msd Sharp & Dohme Gmbh	Recruiting
Haar, Germany, D-85540
Contact: Thomas Lang 49-800 67367367
Israel
Merck Sharp & Dohme Co. Ltd.	Recruiting
Petah Tikva, Israel, 49192
Contact: Baruch Weinreb 972 3 9209000
Korea, Republic of
MSD Korea Ltd.	Recruiting
Seoul, Korea, Republic of, 121-705
Contact: Yong Soo Kim 82263630241
New Zealand
Merck Sharp & Dohme (New Zealand) Ltd.,	Recruiting
Auckland, New Zealand
Contact: Gary Jankelowitz 61 297959962
Poland
MSD Polska Sp. z o.o. Dzial Medyczny	Recruiting
Warszawa, Poland, 00-867
Contact: Adam Czernik +48224784342
Sweden
Merck Sharp & Dohme (Sweden) AB	Recruiting
Sollentuna, Sweden, 192 07
Contact: Tryggve Ljung 46 070 545 2866
Taiwan
Merck Sharp & Dohme (I.A.) Corp.	Recruiting
Taipei, Taiwan, [106
Contact: Lai Hung Jeng 351214465890

Sponsors and Collaborators

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00943761 History of Changes
Other Study ID Numbers:	2009_615, MK-7009-028
Study First Received:	July 21, 2009
Last Updated:	December 2, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

hepatitis C

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
Interferons
Ribavirin
Peginterferon alfa-2a
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012