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).

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]

• Registration Number: NCT00700401
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Study Start: 2008-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2016-03-28
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-12
• Last Update Submitted: 2016-05-12
• Results First Posted: 2016-06-21
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

Inclusion Criteria

• adult patients, >=18 years of age;
• positive serum HCV RNA.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peginterferon Alfa-2a + Ribavirin	peginterferon alfa-2a [Pegasys]	-
Peginterferon Alfa-2a + Ribavirin	ribavirin [Copegus]	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virological Response at Week 48	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 Outcome Measures

Name	Time	Method
Percentage of Participants With Rapid Virological Response at Week 4	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.
Percentage of Participants With Virological Response at Week 24	At Week 24	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	At week 48	Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.
Percentage of Participants With Positive Predictive Value	At Week 48	Positive predictive value is defined as participants with RVR who did not achieve SVR.
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48	At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48	Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.
Number of Participants With Any Adverse Events and Any Serious Adverse Events	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.
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48	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.