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

Hepatitis C, Chronic Clinical Trial

— PRACTICE  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709059
• Other study ID #: P04243
• Status: Completed
• Phase: N/A
• First received: June 23, 2008
• Last updated: November 3, 2015
• Start date: December 2004
• Est. completion date: December 2009

Study information

• Verified date: November 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 538
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• PegIntron (peginterferon alfa-2b; SCH 54031)
PegIntron 1.5 ug/kg body weight per week subcutaneously for 48 weeks

Drug:
• Rebetol (ribavirin; SCH 18908)
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Study Participants Who Had a Virological Response (VR) at 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.	Treatment Week 72	No