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Completed

NCT Number: NCT00940420

A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C

This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Afula, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients >/= 18 years of age
  • serologic evidence of chronic hepatitis C infection
  • compensated liver disease
  • negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment

Exclusion criteria

  • history or other evidence of a medical condition associated with chronic liver disease other than HCV
  • hepatitis A, hepatitis B or HIV infection
  • hepatocellular carcinoma
  • severe concomitant disease

Treatment and study plan

Copegus (ribavirin)

Drug

800 - 1200 mg po daily for 24 weeks

peginterferon alfa-2a [Pegasys]

Drug

180 mcg sc once weekly for 24 weeks

Primary outcomes

  1. safety and tolerability with regard to clinical AEs and laboratory parameters

    Time frame: assessed every 2 weeks throughout study and after 8 weeks follow-up

Secondary outcomes

  1. safety with regard to hematological parameters

    Time frame: assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Safety and Tolerability of Ribavirin (Ro 20-9963) in Combination With Peginterferon Alfa in Patients With Chronic Hepatitis C

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Jul 16, 2009
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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