An Observational Study of Patients With Chronic Hepatitis C Undergoing Treatment With PegIntron and Rebetol in Clinical Practice in Belgium (Study P05494)(WITHDRAWN)

Hepatitis C Clinical Trial

— PEGIMPACT  

Official title:

An Observational Multi-Center Study Exploring the Association of Safety, Patient Characteristics, Virological, and Histological Parameters With Patient Outcome (Relapse Rate, Achievement of Sustained Viral Response in Daily Clinical Practice in Belgium- PEGIMPACT

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00704756
• Other study ID #: P05494
• Status: Withdrawn
• Phase: N/A
• First received: June 23, 2008
• Last updated: August 8, 2014
• Start date: January 2009
• Est. completion date: March 2010

Study information

• Verified date: August 2014
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Central Ethics Committee
• Study type: Observational

Clinical Trial Summary

This is an observational study of patients undergoing treatment with PegIntron and Rebetol for chronic hepatitis C in clinical practice in Belgium. Treatment will not be administered as part of the study. Safety parameters will be assessed retrospectively. Efficacy parameters, such as relapse rates and sustained virologic response rates, will be assessed prospectively. The objective of the study is to examine any associations between safety, virologic, histologic, demographic parameters and patient outcome (relapse rates and sustained virologic response rates).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female adult (18 years or older) subjects for whom the treating physician has decided to start treatment with PegIntron® and Rebetol® and reaching the End-of-Treatment time point.

• For the prospective component, evidence of treatment response at EOT after a complete course of therapy as per SmPC.

• Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.

• Subjects must be diagnosed with chronic hepatitis C (genotypes 1, 2, 3, 4, 5 or 6).

• Subjects must be free of any clinically significant disease that would interfere with study participation.

Exclusion Criteria:

• For prospective component of the study: patients not achieving End-of-Treatment response after a complete course of therapy as per SmPC.

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

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

Intervention

Biological:
• PegIntron (peginterferon alfa-2b; SCH 54031)
PegIntron administered at 1.5 µg/kg body weight/week subcutaneously for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5)

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 up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Van Vlierberghe H, Adler M, Bastens B, Colle I, Delwaide J, Henrion J, Horsmans Y, Michielsen P, Golstein P, Mulkay JP, Van Steenbergen W, Yap P, Nevens F, Denys AM, Brasseur JP. Effectiveness and tolerability of pegylated interferon alfa-2b in combinatio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety parameters: common adverse events [AEs], drug-to-drug interaction AEs, and dose modifications		Assessed retrospectively in patients treated for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5) and reaching End-of-Treatment.	Yes
Secondary	Relapse rates and Sustained Virologic Response (SVR) rates and their association with demographic, virologic, histological, and safety parameters		Assessed prospectively at End-of-Treatment (EOT) and 24 weeks post-treatment	No
Secondary	Predictors of response at End-of-Treatment		Assessed at the End-of-Treatment	No