POTENTE Study: A Study of Early Virological Response in Naive Patients With Chronic Hepatitis C, Genotype 2 or 3, Treated With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin).

Hepatitis C, Chronic Clinical Trial

Official title:

An Open Label Study to Investigate the Effect of PEGASYS Plus Copegus on Sustained Virological Response in Naive Patients With Chronic Hepatitis C, Genotype 2 or 3, Who Have a Virological Response at Week 4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700401
• Other study ID #: ML21543
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2008
• Last updated: January 12, 2015
• Start date: November 2008
• Est. completion date: November 2010

Study information

• Verified date: January 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180 micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• positive serum HCV RNA.

Exclusion Criteria:

• co-infection with HIV or HBV (patients with a positive HBsAg);

• previous treatment with interferon, or peginterferon and/or ribavirin;

• severe hepatic dysfunction or decompensated cirrhosis of liver.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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 micrograms/week sc for 24 weeks
• ribavirin [Copegus]
800mg po daily for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response		Week 48	No
Secondary	Sustained virological response 24 weeks after treatment completion		24 weeks after last dose of study medication	No
Secondary	Virological response at end of treatment		+/- 28 days after last dose of study medication	No
Secondary	Virological relapse		Event driven	No
Secondary	AEs, laboratory parameters.		Throughout study	No