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Completed

NCT Number: NCT00700401

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 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vitória, Espírito Santo, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

peginterferon alfa-2a [Pegasys]

Drug

180 micrograms/week sc for 24 weeks

ribavirin [Copegus]

Drug

800mg po daily for 24 weeks

Primary outcomes

  1. Percentage of Participants With Sustained Virological Response at Week 48

    Time frame: 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).

Secondary outcomes

  1. Percentage of Participants With Rapid Virological Response at Week 4

    Time frame: At Week 4

    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.

  2. Percentage of Participants With Virological Response at Week 24

    Time frame: At Week 24

    Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).

  3. Percentage of Participants With Virological Relapse

    Time frame: At week 48

    Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.

  4. Percentage of Participants With Positive Predictive Value

    Time frame: At Week 48

    Positive predictive value is defined as participants with RVR who did not achieve SVR.

  5. Number of Participants With Any Adverse Events and Any Serious Adverse Events

    Time frame: Up to 48 weeks

    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.

  6. 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

    Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.

  7. 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

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 18, 2008
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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