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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: November 3, 2014
Last verified: November 2014
  Purpose

This single arm study will investigate the predictive value of a week 4 virologi cal response on sustained virological response in patients with chronic hepatiti s 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 ha ve a virological response at week 4 will continue to be treated for 24 weeks, fo llowed by a 24 week treatment-free follow-up. Non-responders at week 4 will be e ntered 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 targe t 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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Porto Alegre, RS, Brazil, 90020-090
Campinas, SP, Brazil, 13060-803
Campinas, SP, Brazil, 13083-888
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: November 3, 2014
Health Authority: Brazil: Ministry of Health

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

ClinicalTrials.gov processed this record on November 27, 2014