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

• ClinicalTrials.gov Identifier: NCT01340573
• Recruitment Status: Terminated
• First Posted: April 22, 2011
• Results First Posted: January 30, 2012
• Last Update Posted: February 2, 2015
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

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.

Condition or disease	Intervention/treatment
Chronic Hepatitis C	Drug: PegIntron Pen; Drug: Ribavirin

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 3 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Non-Interventional Study Evaluating The Safety and Efficacy In Patients Receiving New PegIntron Pen for Hepatitis C
• Study Start Date: March 2007
• Actual Primary Completion Date: October 2007
• Actual Study Completion Date: October 2007

Groups and Cohorts

Group/Cohort	Intervention/treatment
Genotype 1 CHC Participants	Drug: PegIntron Pen; Peginterferon alfa-2b, 1.5 microgram/kg each week, administered subcutaneously.; Other Name: pegylated interferon Pen; Drug: 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.; Other Name: Ribasphere, Vilona, Copegus, Rebetol, Virazole
Non-genotype 1 CHC participants	Drug: PegIntron Pen; Peginterferon alfa-2b, 1.5 microgram/kg each week, administered subcutaneously.; Other Name: pegylated interferon Pen; Drug: 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.; Other Name: Ribasphere, Vilona, Copegus, Rebetol, Virazole

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Secondary Outcome Measures :

1. Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment [ Time Frame: Week-24 ]
   Sustained virologic response (SVR) is the absence of detectable HCV RNA in serum after end of treatment.
2. Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up [ Time Frame: Week-24 follow-up ]
3. Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment [ Time Frame: Week-48 ]
4. Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up [ Time Frame: Week-24 follow-up ]
5. Participants' Overall Rating of Satisfaction and the Use of Training Materials for the Pegintron Pen, as Provided in a Study Questionnaire [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA

Efficacy measurements for sustained viral response HCV RNA were collected at week 24 of study treatment and at week 24 of follow-up in Non-genotype-1 participants. Efficacy measurements for Genotype-1 participants for sustained viral response HCV RNA were collected at week 24 and at week 48 of study treatment, and at week 24 of follow-up.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Indonesian participants ≥18 years of age with confirmed chronic hepatitis C with HCV RNA positive in plasma.

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT01340573
• Other Study ID Numbers: P04896
• First Posted: April 22, 2011
• Results First Posted: January 30, 2012
• Last Update Posted: February 2, 2015
• Last Verified: January 2015

Keywords provided by Merck Sharp & Dohme Corp.:

Chronic Hepatitis C; pegylated interferon; PegIntron Pen; Ribavirin

Additional relevant MeSH terms:

Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Blood-Borne Infections; Communicable Diseases; Flaviviridae Infections; Interferons; Ribavirin; Peginterferon alfa-2b; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action