Evaluating Safety and Efficacy In Hepatitis C Patients After PegIntron Pen Treatment (Study P04896)

Non-Interventional Study Evaluating The Safety and Efficacy In Patients Receiving New PegIntron Pen for Hepatitis C

This is a non-interventional study designed to evaluate the efficacy and safety of combination study drugs in the treatment of participants diagnosed with Chronic Hepatitis C (CHC). CHC participants with confirmed positive hepatitis-C virus (HCV) RNA in plasma, and who have not been previously treated with the Pegylated interferon (PegIntron) Pen, were enrolled into study.

Study Overview

• Status: Terminated
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: PegIntron Pen; Drug: Ribavirin

Detailed Description

Participants with positive genotype-1 HCV RNA received 48 weeks of treatment of PegIntron Pen plus ribavirin and 24 weeks of follow-up. Participants who were non-genotype-1 HCV RNA positive received 24 weeks of treatment of PegIntron Pen plus ribavirin and 24 weeks of follow-up. Participants were asked to complete a questionnaire to measure the satisfaction and the use of training materials of PegIntron pen using a 1-5 score system provided in the questionnaire. The questionnaire was completed once at first follow-up visit. Efficacy measurements for sustained viral response HCV RNA was collected at week-24 of treatment and at week-24 of follow-up in positive Non-genotype-1 HCV RNA participants. Efficacy measurements for sustained viral response HCV RNA was collected at week-24 and at week-48 of treatment, and at week-24 of follow-up, for positive Genotype-1 HCV RNA participants.

• Study Type: Observational
• Enrollment (Actual): 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Indonesian participants ≥18 years of age with confirmed chronic hepatitis C with HCV RNA positive in plasma.

Description

Inclusion Criteria:

• Demonstrate willingness to participate in the study and comply with its procedures by signing a written informed consent.
• Equal to or greater than 18 years.
• Confirmed chronic hepatitis C with hepatitis C virus (HCV) RNA positive in plasma.
• No previous use of PegIntron Pen.

Exclusion Criteria:

• Hypersensitivity to the active substance or to any interferon or to any of the excipients.
• Pregnant women.
• Women who are breastfeeding.
• Existence of or a history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicide attempt.
• A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months.
• Severe debilitating medical condition, including patients with chronic renal failure or creatinine clearance < 50 ml/minute.
• Auto immune hepatitis or a history of autoimmune disease.
• Severe hepatic dysfunction or decompensated cirrhosis of the liver.
• Pre-existing thyroid disease unless it can be controlled with conventional treatment.
• Epilepsy and/or compromised central nervous system (CNS) function.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Genotype 1 CHC Participants	Drug: PegIntron Pen; Peginterferon alfa-2b, 1.5 microgram/kg each week, administered subcutaneously.; Other Names: pegylated interferon Pen; Drug: Ribavirin; Dose is based on body weight. Each tablet of ribavirin is 200mg, and given by oral administration. Participants with body weight of <65 kg were administered 800 mg of ribavirin daily, body weight of 65 kg-85 kg received 1000 mg daily, and participants with a body weight of >85 kg received 1200 mg of ribavirin daily.; Other Names: Ribasphere, Vilona, Copegus, Rebetol, Virazole
Non-genotype 1 CHC participants	Drug: PegIntron Pen; Peginterferon alfa-2b, 1.5 microgram/kg each week, administered subcutaneously.; Other Names: pegylated interferon Pen; Drug: Ribavirin; Dose is based on body weight. Each tablet of ribavirin is 200mg, and given by oral administration. Participants with body weight of <65 kg were administered 800 mg of ribavirin daily, body weight of 65 kg-85 kg received 1000 mg daily, and participants with a body weight of >85 kg received 1200 mg of ribavirin daily.; Other Names: Ribasphere, Vilona, Copegus, Rebetol, Virazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment	Collection of all safety reports (serious adverse events) from genotype-1 population at week-48 of treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.	Week-48
Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up	Collection of all safety reports (serious adverse events) from genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.	Week-24 follow-up
Number of Non-genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 of Study Treatment	Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 of study treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.	Week-24
Number of Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on Week-24 Follow-up	Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.	Week-24 follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment	Sustained virologic response (SVR) is the absence of detectable HCV RNA in serum after end of treatment.	Week-24
Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up		Week-24 follow-up
Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment		Week-48
Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up		Week-24 follow-up
Participants' Overall Rating of Satisfaction and the Use of Training Materials for the Pegintron Pen, as Provided in a Study Questionnaire	Participants will complete a single questionnaire during the first follow-up visit (Week 12). The questionnaire will measure the participant's satisfaction and the use of training materials for the PegIntron Pen during the course of study therapy, as measured by the participant using a 1- 5 score system provided in the questionnaire.	Week 12

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2007
• Primary Completion (Actual): October 29, 2007
• Study Completion (Actual): October 29, 2007

Study Registration Dates

• First Submitted: November 18, 2010
• First Submitted That Met QC Criteria: April 20, 2011
• First Posted (Estimated): April 22, 2011

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Hepatitis C; Ribavirin; pegylated interferon; PegIntron Pen
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Chronic Disease; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Antineoplastic Agents; Interferons; Ribavirin; Peginterferon alfa-2b
• Other Study ID Numbers: P04896