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

• Status: Terminated
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon-alpha; Interferons; Peginterferon alfa-2b; Ribavirin

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.