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

Merck Sharp & Dohme (MSD)

Status

Terminated

Conditions

Chronic Hepatitis C

Treatments

Drug: Ribavirin

Drug: PegIntron Pen

Study type

Observational

Funder types

Industry

Identifiers

NCT01340573

P04896

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.