Phase 3 N=236 Randomized Treatment

The Individualized Management With Pegylated-interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Offering Viral Eradication: A Study of Pegylated-interferon Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C (CHC) Non-genotype 2/3 (IMPROVE)

Hepatitis C, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT00483938 ↗

Enrolled (actual)

236

Serious AEs

11.0%

Results posted

Jan 2017

Primary outcome: Primary: Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B) — 48.8; 39.5 percentage of participants — p=0.510

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Pegylated-interferon Alfa-2a (Drug); Ribavirin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)	48.8; 39.5	0.510
SECONDARY Percentage of Participants With SVR (Groups C, D, E, and F)	73.3; 74.2; 84.0; 84.0	1.000
SECONDARY Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)	80.5; 76.7; 96.7; 90.3; 92.0; 100.0	0.792

Summary

This study will compare the efficacy and safety of treatment with pegylated-interferon alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than or equal to (>=) 2 log10 drop in HCV-RNA. Participants will be randomized to receive pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400 milligram [mg]) orally daily for the specified duration, followed by 24 weeks of treatment-free follow-up. Participants with detectable HCV-RNA and less than (<) 2 log10 drop in HCV-RNA at week 12 will discontinue therapy.

Eligibility Criteria

Inclusion Criteria

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 human immunodeficiency virus (HIV) infection;
history or evidence of a medical condition associated with chronic liver disease other than CHC.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00483938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.