A Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (MASTER)

Hepatitis C, Chronic Clinical Trial

Official title:

Open-label, Multicenter, Non-Comparative Prospective Study to Assess the Safety of Individualized Combination Therapy With Ribavirin And Peginterferon Alfa-2a (40 kD) in Patients With Chronic Hepatitis C (CHC) (MASTER Study)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01296971
• Other study ID #: ML25246
• Status: Withdrawn
• Phase: Phase 3
• First received: December 21, 2010
• Last updated: November 1, 2016
• Start date: December 2009
• Est. completion date: December 2009

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

This open-label, non-comparative study will assess the safety and tolerability of individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype 1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks. For patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48 weeks. Patients who had previously received standard or pegylated interferons but were non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week follow-up.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Chronic hepatitis C

• Measurable serum HVC RNA levels

• Compensated liver disease (Child-Pugh class A)

• Treatment-naive for standard or pegylated interferons, or non-responder or relapsing

Exclusion Criteria:

• Concomitant hepatitis A or B

• History of chronic liver disease not caused by hepatitis C virus

• Hepatocellular carcinoma

• History or signs of esophageal varices haemorrhage or other conditions indicative of decompensated liver disease

• Treatment with any systemic anti-tumor or immunomodulatory agent (including steroids at doses exceeding physiological ones, and radiotherapy) within 6 months prior to first dose of study drug

• Pregnant or lactating women, or men whose partners are pregnant

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• peginterferon alfa-2a [Pegasys]
180 mcg sc weekly
• ribavirin [Copegus]
1'000/1'200 mg daily orally, 24 - 72 weeks
• ribavirin [Copegus]
800 mg daily orally, 16 - 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of individualized Copegus treatment in combination with Pegasys: Adverse events		up to 96 weeks	No
Primary	Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA)		up to 96 weeks	No
Secondary	Virological response/sustained virological response (serum HCV RNA levels)		24 weeks after treatment completion	No