Clinical trial NCT01340573: Evaluating Safety and Efficacy In Hepatitis C Patients After PegIntron Pen Treatment (Study P04896)
Official title: Non-Interventional Study Evaluating The Safety and Efficacy In Patients Receiving New PegIntron Pen for Hepatitis C
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
pegylated interferon
PegIntron Pen
Ribavirin
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-04-22
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Indonesian participants ≥18 years of age with confirmed chronic hepatitis C with HCV RNA positive in plasma.

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.

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.

Primary outcomes:
measure: Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment
timeFrame: Week-48
measure: Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up
timeFrame: Week-24 follow-up
measure: Number of Non-genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 of Study Treatment
timeFrame: Week-24
measure: Number of Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on Week-24 Follow-up
timeFrame: Week-24 follow-up
Secondary outcomes:
measure: Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment
timeFrame: Week-24
measure: Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up
timeFrame: Week-24 follow-up
measure: Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment
timeFrame: Week-48
measure: Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up
timeFrame: Week-24 follow-up
measure: Participants' Overall Rating of Satisfaction and the Use of Training Materials for the Pegintron Pen, as Provided in a Study Questionnaire
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
References: