Non-Interventional Study Evaluating The Safety and Efficacy In Patients Receiving New PegIntron Pen for Hepatitis C
Overview
- Phase
- Not Applicable
- Intervention
- PegIntron Pen
- Conditions
- Chronic Hepatitis C
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 3
- Primary Endpoint
- Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
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.
Arms & Interventions
Non-genotype 1 CHC participants
Intervention: PegIntron Pen
Genotype 1 CHC Participants
Intervention: Ribavirin
Genotype 1 CHC Participants
Intervention: PegIntron Pen
Non-genotype 1 CHC participants
Intervention: Ribavirin
Outcomes
Primary Outcomes
Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment(Week-24)
- 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)