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 (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg 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 Drug: Ribavirin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Randomized, Multicenter, Double-blinded, Phase IV Study Evaluating the Efficacy (as Measured by Sustained Virological Response) and Safety of 360 μg Induction Dosing of Pegasys® in Combination With Higher Copegus® Doses in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater Than or Equal to 85 kg

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A 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:

Sustained Virological Response (SVR)-24 (Scheduled Treatment Period) [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 68 (ie, on or after study day 477).

Secondary Outcome Measures:

SVR-24 (Actual Treatment Period) [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]
SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug.
SVR-12 (Scheduled Treatment Period) [ Time Frame: 12 weeks after end of treatment ] [ Designated as safety issue: No ]
SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 60).
SVR-12 (Actual Treatment Period) [ Time Frame: 12 weeks after end of treatment ] [ Designated as safety issue: No ]
SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug.

Enrollment:	1175
Study Start Date:	February 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PEG-IFN 180 µg + Ribavirin 1200 mg	Drug: peginterferon alfa-2a 180 µg sc weekly for 48 weeks Other Name: Pegasys Drug: Ribavirin 1200 mg po daily for 48 weeks Other Name: Copegus
Experimental: PEG-IFN 180 µg + Ribavirin 1400/1600 mg	Drug: peginterferon alfa-2a 180 µg sc weekly for 48 weeks Other Name: Pegasys Drug: Ribavirin 1400-1600 mg po daily for 48 weeks Other Name: Copegus
Experimental: PEG-IFN 360/180 µg + Ribavirin 1200 mg	Drug: Ribavirin 1200 mg po daily for 48 weeks Other Name: Copegus Drug: peginterferon alfa-2a 360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks Other Name: Pegasys
Experimental: PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg	Drug: peginterferon alfa-2a 360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks Other Name: Pegasys Drug: Ribavirin 1400-1600 mg po daily 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:

Adult patients, ≥18 years of age
CHC infection, genotype 1
Hepatitis C virus (HCV) RNA ≥400,000 IU/mL
Baseline body weight ≥85 kg
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 184 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

Additional Information:

Clinical Study Report Synopsis This link exits the ClinicalTrials.gov site

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Reddy KR, Shiffman ML, Rodriguez-Torres M, Cheinquer H, Abdurakhmanov D, Bakulin I, Morozov V, Silva GF, Geyvandova N, Stanciu C, Rabbia M, McKenna M, Thommes JA, Harrison SA; PROGRESS Study Investigators. Induction pegylated interferon alfa-2a and high dose ribavirin do not increase SVR in heavy patients with HCV genotype 1 and high viral loads. Gastroenterology. 2010 Dec;139(6):1972-83. Epub 2010 Sep 30.

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00394277 History of Changes
Other Study ID Numbers:	NV18210
Study First Received:	October 30, 2006
Results First Received:	May 27, 2010
Last Updated:	July 30, 2010
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
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012