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

NCT ID: NCT01340573

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-23
• Study Completion Date: 2007-10-29

Brief Summary

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.

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.

Conditions

Chronic Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Genotype 1 CHC Participants

PegIntron Pen

Intervention Type: DRUG

Peginterferon alfa-2b, 1.5 microgram/kg each week, administered subcutaneously.

Ribavirin

Intervention Type: DRUG

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.

Non-genotype 1 CHC participants

PegIntron Pen

Intervention Type: DRUG

Peginterferon alfa-2b, 1.5 microgram/kg each week, administered subcutaneously.

Ribavirin

Intervention Type: DRUG

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.

Interventions

PegIntron Pen

Peginterferon alfa-2b, 1.5 microgram/kg each week, administered subcutaneously.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

pegylated interferon Pen; Ribasphere, Vilona, Copegus, Rebetol, Virazole

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04896

Identifier Type: -

Identifier Source: org_study_id