Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED)

October 8, 2015 updated by: Merck Sharp & Dohme LLC

Treatment of Chronic Hepatitis C With PegIntron Injector and Rebetol (Post Marketing Surveillance Study)

The objective of the study is to assess the safety and efficacy of PegIntron injector and Rebetol administered to participants with chronic hepatitis C. Participants will be treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study will assess the rates of eradication of the hepatits C virus and the rates of serious adverse events reported with PegIntron (1.5 μg/kg/week) and Rebetol (800-1200 mg/day) in common medical practice in Germany.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2302

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with chronic hepatitis C, who are either treatment-naïve or previous relapsers after interferon monotherapy, from 500 sites in Germany

Description

Inclusion Criteria:

  • Participants with chronic hepatitis C
  • At least 18 years old
  • Treatment-naïve or relapse to interferon monotherapy
  • Platelets >= 100,000/mm^3
  • Neutrophil counts >= 1,500/ mm^3
  • Thyroid Stimulating Hormone (TSH) must be within normal limits
  • Hemoglobin >= 12 gr/dl (females); >= 13 gr/dl (males)
  • Intravenous drug abusers (Ex-IVDA) participants being under stable substitution for at least 6 months
  • Women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. Sexually active female participants of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment
  • Sexually active male participants must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment

Exclusion Criteria:

  • Contraindications as per the SPC and approved European labeling
  • Hypersensitivity to the active substance or to any inteferons or to any of the excipients
  • Pregnant woman
  • Woman who are breast-feeding
  • Existence of or history of severe psychiatric condition, in particular 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 conditions, including participants with chronic renal failure or creatinine clearance < 50 mL/min
  • Autoimmune hepatitis or history of autoimmune disease
  • Severe hepatic dysfunction or decompensated cirrhosis of the liver
  • Pre-existing thyroid disease unless it can be controlled with conventional therapy
  • Epilepsy and/or compromised central nervous system function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PegIntron + Rebetol
Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy
Biological: PegIntron (peginterferon alfa-2b; SCH 54031) injector
PegIntron administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling
Other Names:
  • SCH 54031
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling
Other Names:
  • SCH 18908

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)
Time Frame: 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6
HCV-RNA level was measured by polymerase chain reaction (PCR).
24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6
Number of Participants With Early Virologic Response (EVR)
Time Frame: Treatment Week 12

EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA

negativity from baseline to Week 12
Treatment Week 12
Number of Participants With Sustained Virologic Response (SVR)
Time Frame: 24 weeks post-treatment (Week 48 or 72, depending on genotype)
SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT
24 weeks post-treatment (Week 48 or 72, depending on genotype)
Number of HCV-RNA Negative Participants at Follow-up
Time Frame: 24 weeks post-treatment (Weeks 48 or 72, depending on genotype)
HCV-RNA was measured by PCR.
24 weeks post-treatment (Weeks 48 or 72, depending on genotype)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

July 30, 2008

First Submitted That Met QC Criteria

July 30, 2008

First Posted (Estimate)

August 1, 2008

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04538

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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