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). - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00700401

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 (40KD) [PEGASYS] Drug: ribavirin [Copegus]	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	100
Study Start Date:	September 2008
Estimated Study Completion Date:	July 2010

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [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

Contacts

Contact: Please reference Study ID Number: ML21543	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Brazil
	Not yet recruiting
SOROCABA, Brazil
	Not yet recruiting
CAMPINAS, Brazil, 13012-970
	Not yet recruiting
SAO LUIS, Brazil, 78048-790
	Recruiting
PORTO ALEGRE, Brazil, 90035-003
	Not yet recruiting
SAO PAULO, Brazil, 04023-900
	Not yet recruiting
VITORIA, Brazil, 29043-260
	Recruiting
BRASILIA, Brazil, 70335-000
	Not yet recruiting
RIO DE JANEIRO, Brazil, 20020
	Not yet recruiting
RIO DE JANEIRO, Brazil
	Not yet recruiting
CAMPINAS, Brazil, 13083-888
	Not yet recruiting
SANTO ANDRE, Brazil, 09060-650
	Not yet recruiting
RIBEIRÃO PRETO, Brazil, 14049-900
	Not yet recruiting
CURITIBA, Brazil, 80060-150
	Recruiting
PORTO ALEGRE, Brazil, 90020-090

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML21543
Study First Received:	June 17, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00700401
Health Authority:	Brazil: Ministry of Health

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Ribavirin
Interferons
Hepatitis, Viral, Human
Hepatitis

Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009