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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00940420
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Copegus (ribavirin) Drug: peginterferon alfa-2a [Pegasys] Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2695 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Tolerability of Ribavirin (Ro 20-9963) in Combination With Peginterferon Alfa in Patients With Chronic Hepatitis C
Study Start Date : October 2002
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arm Intervention/treatment
Experimental: A Drug: Copegus (ribavirin)
800 - 1200 mg po daily for 24 weeks

Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly for 24 weeks

Experimental: B Drug: Copegus (ribavirin)
800 - 1200 mg po daily for 48 weeks

Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly for 48 weeks

Primary Outcome Measures :
  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 Outcome Measures :
  1. safety with regard to hematological parameters [ Time Frame: assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00940420

Afula, Israel, 18101
Ashkelon, Israel, 78278
Bat Yam, Israel
Beer Sheva, Israel, 84105
Hadera, Israel, 38100
Haifa, Israel, 31096
Haifa, Israel, 33394
Haifa, Israel, 34362
Holon, Israel, 58100
Jerusalem, Israel, 91120
Kfar Saba, Israel, 44281
Nahariya, Israel, 22100
Nazareth, Israel
Petach Tikva, Israel, 49100
Petach Tikva, Israel
Ramat Gan, Israel, 52621
Rehovot, Israel, 76100
Safed, Israel, 13110
Tel Aviv, Israel, 6423906
Zerifin, Israel, 6093000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00940420     History of Changes
Other Study ID Numbers: ML16837
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs