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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00940420
First received: July 6, 2009
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety with regard to hematological parameters [ Time Frame: assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up ] [ Designated as safety issue: No ]

Enrollment: 2695
Study Start Date: October 2002
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly for 24 weeks
Drug: Copegus (ribavirin)
800 - 1200 mg po daily for 24 weeks
Experimental: B Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly for 48 weeks
Drug: Copegus (ribavirin)
800 - 1200 mg po daily for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940420

Locations
Israel
Afula, Israel, 18101
Ashkelon, Israel, 78278
Bat Yam, Israel
Beer Sheva, Israel, 84105
Hadera, Israel, 38100
Haifa, Israel, 33394
Haifa, Israel, 31096
Haifa, Israel, 34362
Holon, Israel, 58100
Jerusalem, Israel, 91120
Kfar Saba, Israel, 44281
Nahariya, Israel, 22100
Nazareth, Israel
Petach Tikva, Israel
Petach Tikva, Israel, 49100
Ramat Gan, Israel, 52621
Rehovot, Israel, 76100
Safed, Israel, 13110
Tel Aviv, Israel, 6423906
Zerifin, Israel, 70300
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00940420     History of Changes
Other Study ID Numbers: ML16837
Study First Received: July 6, 2009
Last Updated: April 7, 2014
Health Authority: Israel: Israeli Ministry of Health

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

ClinicalTrials.gov processed this record on April 17, 2014