Trial Information

Summary: A Study of Induction Dosing With PEGASYS (Peginterferon alfa-2a (40KD)) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C.

Status: No longer recruiting

Protocol Number: NV18210

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific 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

Brief Summary: 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. Target sample size is 1140.

Study Phase: IV

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Hepatitis C, Chronic

Intervention Type: Drug

Intervention Name: peginterferon alfa-2a (40KD) [PEGASYS]

Primary Outcome: 1. SVR Time frame: Week 72

Key Secondary Outcomes: 1. SVR Time frame: 24 weeks after end of treatment 2. Virological response Time frame: Week 48 and 60, and 12 weeks after end of treatment 3. AEs, laboratory parameters, Beck Depression Inventory Time frame: Throughout study

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.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: February, 2007

Trial Registration Date: 10/30/2006

Date Last Updated: 09/19/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Birmingham, AL 35294
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: October 6, 2008 at 2:49:04 PM


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