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

NCT01296971 | Withdrawn Phase 3

• 1 other identifier: ML25246
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (2)

• Safety of individualized Copegus treatment in combination with Pegasys: Adverse events

  up to 96 weeks

• Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA)

  up to 96 weeks

Secondary Outcomes (1)

• Virological response/sustained virological response (serum HCV RNA levels)

  24 weeks after treatment completion

Study Arms (3)

A

EXPERIMENTAL

genotype 1, treatment-naive

Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]

B

EXPERIMENTAL

genotype 2 and 3, treatment-naive

Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]

C

EXPERIMENTAL

all genotypes, non-responders or relapses

Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]

Interventions

peginterferon alfa-2a [Pegasys] DRUG

180 mcg sc weekly

A; B; C

ribavirin [Copegus] DRUG

1'000/1'200 mg daily orally, 24 - 72 weeks

A; C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: February 16, 2011
• Study Start: December 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 2, 2016

Record last verified: 2016-11