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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394277
• Other study ID #: NV18210
• Status: Completed
• Phase: Phase 4
• First received: October 30, 2006
• Last updated: July 30, 2010
• Start date: February 2007
• Est. completion date: April 2009

Study information

• Verified date: July 2010
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1175
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• peginterferon alfa-2a
180 µg sc weekly for 48 weeks
• Ribavirin
1200 mg po daily for 48 weeks
• peginterferon alfa-2a
360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks
• Ribavirin
1400-1600 mg po daily for 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  Denmark,  France,  Germany,  Hungary,  Netherlands,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)	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).	Week 72	No
Secondary	SVR-24 (Actual Treatment Period)	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.	24 weeks after end of treatment	No
Secondary	SVR-12 (Scheduled Treatment Period)	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).	12 weeks after end of treatment	No
Secondary	SVR-12 (Actual Treatment Period)	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.	12 weeks after end of treatment	No

External Links

•   Clinical Study Report Synopsis