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

Merck Sharp & Dohme LLC3 enrolled

Overview

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.

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

Conditions

Chronic Hepatitis C

Interventions

PegIntron PenDRUG

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

RibavirinDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Week-24 follow-up

Secondary Outcomes

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.

Time frame: Week-24

Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up

Data from ClinicalTrials.gov

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