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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).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00700401
First received: June 17, 2008
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: peginterferon alfa-2a [Pegasys]
Drug: ribavirin [Copegus]
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virological response [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sustained virological response 24 weeks after treatment completion [ Time Frame: 24 weeks after last dose of study medication ] [ Designated as safety issue: No ]
  • Virological response at end of treatment [ Time Frame: +/- 28 days after last dose of study medication ] [ Designated as safety issue: No ]
  • Virological relapse [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 266
Study Start Date: November 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms/week sc for 24 weeks
Drug: ribavirin [Copegus]
800mg po daily for 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700401

Locations
Brazil
Brasilia, DF, Brazil, 70335900
Vitoria, ES, Brazil, 29043-260
Sao Luis, MA, Brazil, 65020560
Rio de Janeiro, RJ, Brazil, 20020-022
Porto Alegre, RS, Brazil, 90035-003
Campinas, SP, Brazil, 13083-888
Campinas, SP, Brazil, 13060-803
Ribeirao Preto, SP, Brazil, 14049-900
Santo Andre, SP, Brazil, 09060-650
Sao Paulo, SP, Brazil, 04040-003
Sorocaba, SP, Brazil, 18047-600
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00700401     History of Changes
Other Study ID Numbers: ML21543
Study First Received: June 17, 2008
Last Updated: May 23, 2013
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013