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With Chronic Hepatitis C Undergoing Treatment With PegIntron and Rebetol in Clinical Practice in Belgium (Study P05494)(WITHDRAWN)

NCT00704756 | Withdrawn

• 1 other identifier: P05494
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Hepatitis C, Chronic; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• 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

• Predictors of response at End-of-Treatment

  Assessed at the End-of-Treatment

Study Arms (1)

Arm 1

Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium.

Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908)

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031) BIOLOGICAL

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)

Also known as: SCH 54031

Arm 1

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

Also known as: SCH 18908

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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 combination with ribavirin for treatment of chronic hepatitis C: the PegIntrust study. Acta Gastroenterol Belg. 2010 Jan-Mar;73(1):5-11.

  PMID: 20458844 RESULT

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 25, 2008
• Study Start: January 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 11, 2014

Record last verified: 2014-08