Evaluating Safety and Efficacy In Hepatitis C Patients After PegIntron Pen Treatment (Study P04896)
- Registration Number
- NCT01340573
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Genotype 1 CHC Participants PegIntron Pen - Non-genotype 1 CHC participants PegIntron Pen - Genotype 1 CHC Participants Ribavirin - Non-genotype 1 CHC participants Ribavirin -
- Primary Outcome Measures
Name Time Method Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up 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.
Number of Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on Week-24 Follow-up 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.
Number of Non-genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 of Study Treatment Week-24 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.
Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment Week-48 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.
- Secondary Outcome Measures
Name Time Method Number of Non-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 Week 12 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.
Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment Week-24 Sustained virologic response (SVR) is the absence of detectable HCV RNA in serum after end of treatment.
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