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.

This study has been completed.

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00483938

First received: June 7, 2007

Last updated: October 15, 2010

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 7, 2007

Last Updated Date

October 15, 2010

Start Date ^ICMJE

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sustained virologic response [ Time Frame: 24 weeks post-transplant ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Sustained virological response (SVR) at 24 weeks post-treatment.

Change History

Complete list of historical versions of study NCT00483938 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

SVR [ Time Frame: At intervals post-transplant ] [ Designated as safety issue: No ]
Viral kinetics [ Time Frame: At intervals during study ] [ Designated as safety issue: No ]
AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Efficacy: SVR at 24 wks after 32 vs 48 wks t'ment in pts with undetectable viral load at wk 8, and 24 vs 48 wks t'ment in pts with undetectable viral load at wk 4. Viral kinetics. Safety: AEs, lab parameters. PK: Ribavirin conc. at weeks 1-12

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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.

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hepatitis C, Chronic

Intervention ^ICMJE

Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks
Drug: peginterferon alfa-2a [Pegasys]
180micrograms sc weekly for 72 weeks
Drug: ribavirin
1000-1400mg po daily for 48 weeks
Drug: ribavirin
1000-1400mg po daily for 72 weeks

Study Arm (s)

Experimental: 1
Interventions:
- Drug: peginterferon alfa-2a [Pegasys]
- Drug: ribavirin
Active Comparator: 2
Interventions:
- Drug: peginterferon alfa-2a [Pegasys]
- Drug: ribavirin

Publications *

Lee SS, Sherman M, Ramji A, Greenbloom S, Elkashab M, Pluta H, Hilzenrat N, Balshaw R, Usaty C, Myers RP. Randomised clinical trial: the efficacy of treatment, guided by a shorter duration of response, using peginterferon alfa-2a plus ribavirin for hepatitis C virus other than genotypes 2 or 3. Aliment Pharmacol Ther. 2012 Jan;35(1):37-47. Epub 2011 Nov 2.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

226

Completion Date

June 2010

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00483938

Other Study ID Numbers ^ICMJE

ML21035

Has Data Monitoring Committee

Responsible Party

Disclosures Group, Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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