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).
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.
1 other identifier
observational
262
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2008
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
June 21, 2016
CompletedJune 21, 2016
May 1, 2016
2 years
June 17, 2008
March 28, 2016
May 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virological Response at Week 48
Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).
At Week 48
Secondary Outcomes (7)
Percentage of Participants With Rapid Virological Response at Week 4
At Week 4
Percentage of Participants With Virological Response at Week 24
At Week 24
Percentage of Participants With Virological Relapse
At week 48
Percentage of Participants With Positive Predictive Value
At Week 48
Number of Participants With Any Adverse Events and Any Serious Adverse Events
Up to 48 weeks
- +2 more secondary outcomes
Study Arms (1)
Peginterferon Alfa-2a + Ribavirin
Interventions
180 micrograms/week sc for 24 weeks
Eligibility Criteria
Participants with serologically proven chronic hepatitis C and genotype 2 or 3, with or without cirrhosis and compensated liver disease (Child-Pugh A cirrhosis.)
You may qualify if:
- adult patients, \>=18 years of age;
- positive serum HCV RNA.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Unknown Facility
Vitória, Espírito Santo, 29043-260, Brazil
Unknown Facility
Brasília, Federal District, 70335900, Brazil
Unknown Facility
São Luís, Maranhão, 65020560, Brazil
Unknown Facility
Rio de Janeiro, Rio de Janeiro, 20020-022, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Unknown Facility
Campinas, São Paulo, 13060-803, Brazil
Unknown Facility
Campinas, São Paulo, 13083-888, Brazil
Unknown Facility
Ribeirão Preto, São Paulo, 14049-900, Brazil
Unknown Facility
Santo André, São Paulo, 09060-650, Brazil
Unknown Facility
São Paulo, São Paulo, 04040-003, Brazil
Unknown Facility
Sorocaba, São Paulo, 18047-600, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2008
First Posted
June 18, 2008
Study Start
November 1, 2008
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
June 21, 2016
Results First Posted
June 21, 2016
Record last verified: 2016-05