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OpenTrials
Completed

NCT Number: NCT00709059

Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)

The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antiviral therapy prior to the current study. Only patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will also explore the influence of liver fibrosis stage on the chances of achieving a sustained virologic response.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Previously untreated ('treatment naïve') adults (18 year or more) for whom the treating physician has decided to start treatment with PegIntron and Rebetol
  • Detectable Hepatitis C Virus - Ribonucleic Acid (HCV-RNA) in serum by Polymerase Chain Reaction (PCR)
  • Repeated (with at least a 1 month interval) serum transaminase (alanine aminotransferase [ALT]) levels above the upper normal limit for gender
  • Documented chronic hepatitis C (CHC) of genotype 1/4/5/6
  • A representative liver biopsy within 1 year prior to inclusion, allowing fibrosis grading into METAVIR score F0, F1, F2, F3 or F4

Exclusion criteria

  • Known hypersensitivity for any active ingredient or constituent
  • Pregnancy or lactation
  • Medically documented history of severe psychiatric disturbance, including severe depression, suicidal ideation or suicide attempt
  • Medically documented history of severe heart disease, including unstable or uncontrolled cardiac disease, within the last 6 months
  • Severely weakening medical condition, including chronic renal insufficiency or creatinine clearance <50 mL/minute
  • Hepatitis of immunologic origin or medically documented history of auto-immune disease
  • Severe hepatic disorder or decompensated cirrhosis
  • Pre-existing thyroid disorder, except if under control with classical treatment
  • Epilepsy or central nervous system disorder
  • Hemoglobin pathology, eg, thalassaemia, sickle cell anemia

Treatment and study plan

PegIntron (peginterferon alfa-2b; SCH 54031)

Biological

PegIntron 1.5 ug/kg body weight per week subcutaneously for 48 weeks

Other names: SCH 54031

REBETOL (ribavirin; SCH 18908)

Drug

Rebetol administered based on body weight 800-1200 mg/day (<65 kg: 800 mg; 65 - 85 kg: 1000 mg; >85 kg: 1200 mg) orally for 48 weeks

Other names: SCH 18908

Primary outcomes

  1. Number of Study Participants Who Had a Virological Response (VR) at Week-72

    Time frame: Treatment Week 72

    VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test.

    Participants who dropped out or were withdrawn from treatment were considered not to respond.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Non-interventional Phase IV Survey to Assess the Antiviral Effectiveness of PegIntron® and Rebetol® Treatment According to the Stage of Liver Fibrosis in Previously Untreated Patients With Genotype 1/4/5/6 Chronic Hepatitis C (CHC) (PRACTICE)

Acronym: PRACTICE

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Jul 3, 2008
Registry last updated
Nov 4, 2015

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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