A Study of Mericitabine in Combination With Telaprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C - Full Text View

Purpose

This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with telaprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: mericitabine Drug: Placebo Drug: Pegasys Drug: Copegus Drug: telaprevir	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A PHASE II, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PARALLEL GROUP STUDY TO EVALUATE THE SUSTAINED VIROLOGIC RESPONSE OF THE HCV POLYMERASE INHIBITOR PRODRUG RO5024048 IN COMBINATION WITH TELAPREVIR AND PEGASYS®/COPEGUS® IN PATIENTS WITH CHRONIC HEPATITIS C GENOTYPE 1 VIRUS INFECTION WHO WERE PRIOR NULL RESPONDERS TO TREATMENT WITH PEGYLATED INTERFERON/RIBAVIRIN

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a Telaprevir

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Sustained virological response 12 weeks after treatment (SVR-12) [ Time Frame: up to 60 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sustained virological response 4 weeks after treatment (SVR-4) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
Virologic response over time [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
Proportion of patients who develop treatment resistance [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
Safety (incidence of adverse events) [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
Pharmacokinetics: trough concentration of RO4995855 [ Time Frame: Day 1 and Week 8 ] [ Designated as safety issue: No ]
Pharmacokinetics: trough concentration of RO5012433 [ Time Frame: Day 1 and Week 8 ] [ Designated as safety issue: No ]
Pharmacokinetics: trough concentration of telaprevir [ Time Frame: Day 1 and Week 8 ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	December 2011
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: mericitabine 1000 mg twice daily for 24 weeks Drug: Pegasys 180 microgram subcutaneous once weekly for 24 weeks Drug: Copegus total daily dose of 1000 mg or 1200 mg for 24 weeks Drug: telaprevir 750 mg three times daily for 12 weeks
Experimental: B	Drug: mericitabine 1000 mg twice daily for 24 weeks Drug: Pegasys 180 microgram subcutaneous once weekly for 48 weeks Drug: Copegus total daily dose of 1000 mg or 1200 mg for 48 weeks Drug: telaprevir 750 mg three times daily for 12 weeks
Experimental: C	Drug: mericitabine 1000 mg twice daily for 12 weeks Drug: Placebo Placebo to RO5024048 for 12 weeks (weeks 12-24) Drug: Pegasys 180 microgram subcutaneous once weekly for 48 weeks Drug: Copegus total daily dose of 1000 mg or 1200 mg for 48 weeks Drug: telaprevir 750 mg three times daily for 12 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Adult patients, >/=18 years of age
Chronic hepatitis C infection for at least 6 months duration
Hepatitis C genotype 1a or 1b
Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
Patients showed a previous null response to therapy as defined by < 2 log10 IU/ml decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Exclusion Criteria:

Hepatitis C infection with a genotype other than genotype 1a or 1b
Body mass index <18 or >/=36
Hepatitis A, hepatitis B, or HIV infection
Herbal remedies </=1 month prior to the first dose of study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482390

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Locations

United States, Alabama

Birmingham, Alabama, United States, 35209
United States, California

Long Beach, California, United States, 90822

Sacramento, California, United States, 95825

San Diego, California, United States, 92103
United States, Connecticut

New Haven, Connecticut, United States, 06510
United States, Florida

Naples, Florida, United States, 34102
United States, Maryland

Lutherville, Maryland, United States, 21093
United States, Massachusetts

Framingham, Massachusetts, United States, 01702
United States, Missouri

St. Louis, Missouri, United States, 63104
United States, New York

New York, New York, United States, 10021
United States, North Carolina

Statesville, North Carolina, United States, 28677
United States, Ohio

Cincinnati, Ohio, United States, 45267-0595
United States, Texas

Dallas, Texas, United States, 75246
United States, Virginia

Richmond, Virginia, United States, 23249
United States, Washington

Seattle, Washington, United States, 98104
Canada, British Columbia

Vancouver, British Columbia, Canada, V6Z 2K5

Vancouver, British Columbia, Canada, V5Z 1M9

Victoria, British Columbia, Canada, V8V 3P9
Canada, Manitoba

Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario

Toronto, Ontario, Canada, M5G 1L7

Woodbridge, Ontario, Canada, L4L 4Y7
Canada, Quebec

Montreal, Quebec, Canada, H2X2P4
France

Lille, France, 59037

Marseille, France, 13285

Toulouse, France, 31059
Germany

Frankfurt Am Main, Germany, 60590

Freiburg, Germany, 79106

Kiel, Germany, 24105
Italy

Bologna, Italy, 40138

Milano, Italy, 20162

Pisa, Italy, 56124
Spain

La Laguna, Tenerife, Spain, 38320

Barcelona, Spain, 08035

Barcelona, Spain, 08036

Madrid, Spain, 28029
United Kingdom

Dorset, United Kingdom, BH7 7DW

London, United Kingdom, SE5 9RS

London, United Kingdom, SW17 0QT

London, United Kingdom, W2 1NY

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01482390 History of Changes
Other Study ID Numbers:	NV27779, 2011-002715-28
Study First Received:	November 28, 2011
Last Updated:	June 18, 2013
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013