Clinical trial NCT00700401: 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).
Official title: A Prospective, Observational Study to Assess the Virological Response at Week 4 to the Therapy With PEGASYS® (Peginterferon Alfa 2a) Plus COPEGUS® (Ribavirin) in a Population of Treatment Naïve Patients With Chronic Hepatitis C, Genotype 2 or 3.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with serologically proven chronic hepatitis C and genotype 2 or 3, with or without cirrhosis and compensated liver disease (Child-Pugh A cirrhosis.)

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virological Response at Week 48
timeFrame: At Week 48
Secondary outcomes:
measure: Percentage of Participants With Rapid Virological Response at Week 4
timeFrame: At Week 4
measure: Percentage of Participants With Virological Response at Week 24
timeFrame: At Week 24
measure: Percentage of Participants With Virological Relapse
timeFrame: At week 48
measure: Percentage of Participants With Positive Predictive Value
timeFrame: At Week 48
measure: Number of Participants With Any Adverse Events and Any Serious Adverse Events
timeFrame: Up to 48 weeks
measure: Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
timeFrame: At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48
measure: Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
timeFrame: Baseline, Week 4, Week 12, Week 24 and Week 48
Other outcomes:
Locations:
city: Brasilia
country: Brazil
state: DF
city: Vitoria
country: Brazil
state: ES
city: Sao Luis
country: Brazil
state: MA
city: Rio de Janeiro
country: Brazil
state: RJ
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Campinas
country: Brazil
state: SP
city: Campinas
country: Brazil
state: SP
city: Ribeirao Preto
country: Brazil
state: SP
city: Santo Andre
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sorocaba
country: Brazil
state: SP
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: