Text Size

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

This study has been terminated.
(Terminated early due to low enrollment.)
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT01340573
First received: November 18, 2010
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Chronic Hepatitis C
 Drug: PegIntron Pen
Drug: Ribavirin
 Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment [ Time Frame: Week-48 ] [ Designated as safety issue: Yes ]
    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.

  • Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up [ Time Frame: Week-24 follow-up ] [ Designated as safety issue: Yes ]
    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) at Week-24 of Study Treatment [ Time Frame: Week-24 ] [ Designated as safety issue: Yes ]
    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 Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on Week-24 Follow-up [ Time Frame: Week-24 follow-up ] [ Designated as safety issue: Yes ]
    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:
  • Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment [ Time Frame: Week-24 ] [ Designated as safety issue: No ]
    Sustained virologic response (SVR) is the absence of detectable HCV RNA in serum after end of treatment.

  • Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up [ Time Frame: Week-24 follow-up ] [ Designated as safety issue: No ]
  • Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment [ Time Frame: Week-48 ] [ Designated as safety issue: No ]
  • Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up [ Time Frame: Week-24 follow-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 3
Study Start Date: March 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01340573     History of Changes
Other Study ID Numbers: P04896
Study First Received: November 18, 2010
Results First Received: October 4, 2011
Last Updated: December 22, 2011
Health Authority: Indonesia: Departement Kesehatan (Department of Health)

Keywords provided by Schering-Plough:
Chronic Hepatitis C
pegylated interferon
PegIntron Pen
Ribavirin

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Interferons
Ribavirin
Peginterferon alfa-2b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013