A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3

Hepatitis C, Chronic Clinical Trial

Official title:

Randomized, Multicenter Study to Compare Pegylated Interferon Alfa (PEG-IFN) in Combination With Two Different Doses of Ribavirin in Patients With Chronic Hepatitis C and Subtype 2/3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258101
• Other study ID #: ML17087
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2010
• Last updated: October 1, 2015
• Start date: May 2003
• Est. completion date: December 2010

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial Summary

This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients, 18-65 years of age

• Chronic hepatitis C, genotype 2 or 3

• Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test)

• Abdominal sonography within 3 months prior to study start

Exclusion Criteria:

• Previous interferon and/or pegylated interferon and ribavirin therapy

• Liver cirrhosis, class B or C (Child-Pugh)

• Systemic anti-neoplastic or immunomodulatory treatment <=6 months before study drug

• History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C

• Decompensated liver disease

• Positive for HIV

Study Design

Allocation: 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, 24 weeks
• peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 16 weeks
• ribavirin
800 mg orally daily
• ribavirin
400 mg orally daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virologic response rate (Hepatitis C Virus-RNA determined by AMPLICOR HCV test)		40 weeks	No
Primary	Hepatitis C Virus-RNA determined by AMPLICOR HCV test)		48 weeks	No
Secondary	Virologic response rates (Hepatitis C Virus-RNA determined by AMPLICOR HCV test)		16 weeks	No
Secondary	Virologic response rates (Hepatitis C Virus-RNA determined by AMPLICOR HCV test)		24 weeks	No
Secondary	Safety: incidence of adverse events		48 weeks	No
Secondary	Hemoglobin levels at end of treatment		16 weeks	No
Secondary	Hemoglobin levels at end of treatment		48 weeks	No
Secondary	Health Survey (Short Form 36)		48 weeks	No
Secondary	Fatigue Severity Scale		48 weeks	No