A Study of Combination Therapy With PEGASYS (Peginterferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response. - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00623428

Purpose

This study will evaluate the efficacy and safety of PEGASYS + Copegus combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3. Patients receiving PEGASYS (180 micrograms sc weekly) + Copegus (800-1200mg po daily) who do not achieve a rapid viral response at week 4 will enter the study between treatment week 6 and 8, and will receive study medication. Those who have an early virological response at week 12, and are still taking medication at week 24, will then be randomized to one of 2 study groups. Group 1 will stop treatment at this point and will have a 48 week post-treatment observation period, and Group 2 will stay on medication for a further 24 weeks, followed by a 24 week post-treatment observation period. The anticipated time on study treatment is 6-12 months, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: peginterferon alfa-2a (40KD) [PEGASYS] Drug: peginterferon alfa-2a [PEGASYS] Drug: Copegus	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-label Study of the Effects of 24 vs 48 Weeks of Combination Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) Plus COPEGUS (Ribavirin) on Sustained Virological Response in Patients With Chronic Hepatitis C, Genotype 2 or 3 Who do Not Achieve a Rapid Viral Response.

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

SVR [ Time Frame: 24 weeks post-treatment (week 48 for Group 1, and week 72 for Group 2). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients with non-detectable HCV-RNA [ Time Frame: End of treatment (week 24 for Group 1 and week 48 for Group 2) ] [ Designated as safety issue: No ]
Percentage of patients with >=2 log10 drop in HCV-RNA [ Time Frame: Treatment week 12 ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	April 2008
Estimated Study Completion Date:	May 2011

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc weekly for 24 weeks (18 weeks on study) Drug: Copegus 800-1200mg po daily for 24 weeks (18 on study)
2: Active Comparator	Drug: peginterferon alfa-2a [PEGASYS] 180 micrograms sc weekly for 48 weeks (42 on study) Drug: Copegus 800-1200mg po daily for 48 weeks (42 on study)

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;
serological evidence of chronic hepatitis C (CHC);
CHC genotype 2 or 3;
receiving PEGASYS + Copegus according to local standard of care and no RVR;
compensated liver disease.

Exclusion Criteria:

pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
coinfection with hepatitis A or B, or HIV;
history or other evidence of decompensated liver disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623428

Contacts

Contact: Please reference Study ID Number: MV21371

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Show 106 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Disclosures Group )
Study ID Numbers:	MV21371, 2007-004993-15
Study First Received:	February 18, 2008
Last Updated:	October 15, 2009
ClinicalTrials.gov Identifier:	NCT00623428 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Liver Diseases
Flaviviridae Infections
Hepatitis, Chronic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Ribavirin
Physiological Effects of Drugs
Hepatitis, Viral, Human
Therapeutic Uses
Hepatitis C
Angiogenesis Modulating Agents

Growth Inhibitors
RNA Virus Infections
Growth Substances
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Peginterferon alfa-2a
Interferon Alfa-2a
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on November 05, 2009