IMPROVE Study(The Individualized Management With PEGASYS and Ribavirin Offering Viral Eradication): A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Non-Genotype 2/3.

Hepatitis C, Chronic Clinical Trial

Official title:

A Randomized, Open Label Study to Evaluate the Effect of 48 or 72 Weeks of Treatment With Pegasys Plus Copegus Combination Therapy on Sustained Viral Response in Non-genotype 2/3 Patients With Chronic Hepatitis C Who Show a Response at Week 12

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483938
• Other study ID #: ML21035
• Status: Completed
• Phase: Phase 3
• First received: June 7, 2007
• Last updated: April 2, 2016
• Start date: June 2007
• Est. completion date: May 2010

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

This study will compare the efficacy and safety of 48 weeks and 72 weeks treatment with PEGASYS plus ribavirin in patients with non-genotype 2/3 chronic hepatitis C who, after 12 weeks of study treatment, have undetectable HCV-RNA or a >=2 log10 drop in HCV-RNA. Patients will be randomized to receive PEGASYS 180 micrograms sc weekly plus ribavirin (1000-1400mg) po daily for either 48 or 72 weeks, followed by 24 weeks of treatment-free follow-up. Patients with detectable HCV-RNA and <2 log10 drop in HCV-RNA at week 12 will discontinue therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• evidence of CHC;

• evidence of hepatitis C non-genotype 2 or 3;

• compensated liver disease.

Exclusion Criteria:

• infection with HCV genotype 2 or 3;

• history of having received systemic antiviral therapy with activity against CHC <=3 months prior to start of study;

• hepatitis A, hepatitis B or HIV infection;

• history or evidence of a medical condition associated with chronic liver disease other than CHC.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, 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 micrograms sc weekly for 48 weeks
• peginterferon alfa-2a [Pegasys]
180micrograms sc weekly for 72 weeks
• ribavirin
1000-1400mg po daily for 48 weeks
• ribavirin
1000-1400mg po daily for 72 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virologic response		24 weeks post-transplant	No
Secondary	SVR		At intervals post-transplant	No
Secondary	Viral kinetics		At intervals during study	No
Secondary	AEs, laboratory parameters		Throughout study	No