A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C. - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00394277

Purpose

This 4 arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus,and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C genotype 1 infection of high viral titer, and baseline body weight >=85kg, will be randomized to one of 4 groups, to receive a)PEGASYS 180 micrograms sc weekly plus Copegus 1200mg po daily, b)PEGASYS 180 micrograms sc weekly plus Copegus 1400-1600mg po daily, c)PEGASYS 360 micrograms sc weekly (induction) followed by 180 micrograms sc weekly (maintenance) plus Copegus 1200mg po daily or d)PEGASYS 360 micrograms sc weekly (induction) followed by 180 micrograms sc weekly (maintenance) plus Copegus 1400-1600mg po daily. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-blind Study of the Effect on Sustained Viral Response, and the Safety, of Standard or 360 ug PEGASYS Induction Dosing in Combination With Standard or Higher Dose Copegus in Treatment-naive Chronic Hepatitis C Patients Weighing >85kg With Genotype 1 High Viral Titer Infection

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: Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SVR [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]
Virological response [ Time Frame: Week 48 and 60, and 12 weeks after end of treatment ] [ Designated as safety issue: No ]
AEs, laboratory parameters, Beck Depression Inventory [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	1175
Study Start Date:	February 2007
Estimated Study Completion Date:	March 2009

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc weekly for 48 weeks Drug: Copegus 1200mg po daily for 48 weeks
2: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc weekly for 48 weeks Drug: Copegus 1400-1600mg po daily for 48 weeks
3: Experimental	Drug: Copegus 1200mg po daily for 48 weeks Drug: peginterferon alfa-2a (40KD) [PEGASYS] 360 micrograms sc weekly decreasing to 180 micrograms sc weekly for 48 weeks
4: Experimental	Drug: Copegus 1400-1600mg po daily for 48 weeks Drug: peginterferon alfa-2a (40KD) [PEGASYS] 360 micrograms sc weekly decreasing to 180 micrograms sc weekly for 48 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;
CHC infection, genotype 1;
HCV RNA >=400,000 IU/mL;
baseline body weight >=85kg;
liver biopsy (within 24 months of first dose) with results consistent with CHC.

Exclusion Criteria:

previous treatment with interferon, ribavirin, viramidine, levovirin, HCV polymerase or protease inhibitors;
other forms of liver disease, including liver cancer;
human immunodeficiency virus infection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394277

Show 185 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NV18210
Study First Received:	October 30, 2006
Last Updated:	September 16, 2009
ClinicalTrials.gov Identifier:	NCT00394277 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 27, 2009