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.
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2007 |
| End Date: | May 2010 |
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
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.
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.
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.
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