Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 12, 2016
Last verified: May 2016
  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
Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Drug: ribavirin [Copegus]

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Sustained Virological Response at Week 48 [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Percentage of Participants With Rapid Virological Response at Week 4 [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
    Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR.

  • Percentage of Participants With Virological Response at Week 24 [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
    Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).

  • Percentage of Participants With Virological Relapse [ Time Frame: At week 48 ] [ Designated as safety issue: No ]
    Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.

  • Percentage of Participants With Positive Predictive Value [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
    Positive predictive value is defined as participants with RVR who did not achieve SVR.

  • Number of Participants With Any Adverse Events and Any Serious Adverse Events [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.

  • Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 [ Time Frame: At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48 ] [ Designated as safety issue: No ]
    Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.

  • Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 [ Time Frame: Baseline, Week 4, Week 12, Week 24 and Week 48 ] [ Designated as safety issue: No ]
    Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of >3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance.


Enrollment: 262
Study Start Date: November 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Peginterferon Alfa-2a + Ribavirin 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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
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, 90020-090
Porto Alegre, RS, Brazil, 90035-003
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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00700401     History of Changes
Other Study ID Numbers: ML21543 
Study First Received: June 17, 2008
Results First Received: March 28, 2016
Last Updated: May 12, 2016
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016