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

Chronic Hepatitis C Clinical Trial

Official title:

Non-Interventional Study Evaluating The Safety and Efficacy In Patients Receiving New PegIntron Pen for Hepatitis C

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01340573
• Other study ID #: P04896
• Status: Terminated
• Phase: N/A
• First received: November 18, 2010
• Last updated: January 20, 2015
• Start date: March 2007
• Est. completion date: October 2007

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• PegIntron Pen
Peginterferon alfa-2b, 1.5 microgram/kg each week, administered subcutaneously.
• Ribavirin
Dose is based on body weight. Each tablet of ribavirin is 200mg, and given by oral administration. Participants with body weight of <65 kg were administered 800 mg of ribavirin daily, body weight of 65 kg-85 kg received 1000 mg daily, and participants with a body weight of >85 kg received 1200 mg of ribavirin daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment	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.	Week-48	Yes
Primary	Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at 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.	Week-24 follow-up	Yes
Primary	Number of Non-genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 of Study Treatment	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.	Week-24	Yes
Primary	Number of Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on 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.	Week-24 follow-up	Yes
Secondary	Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment	Sustained virologic response (SVR) is the absence of detectable HCV RNA in serum after end of treatment.	Week-24	No
Secondary	Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up		Week-24 follow-up	No
Secondary	Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment		Week-48	No
Secondary	Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up		Week-24 follow-up	No
Secondary	Participants' Overall Rating of Satisfaction and the Use of Training Materials for the Pegintron Pen, as Provided in a Study Questionnaire	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.	Week 12	No