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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00727311
First received: July 30, 2008
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Hepatitis C, Chronic
Hepatitis C
Biological: PegIntron (peginterferon alfa-2b; SCH 54031) injector
Drug: Rebetol (ribavirin; SCH 18908)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Treatment of Chronic Hepatitis C With PegIntron Injector and Rebetol (Post Marketing Surveillance Study)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    HCV-RNA level was measured by polymerase chain reaction (PCR).

  • Number of Participants With Early Virologic Response (EVR) [ Time Frame: Treatment Week 12 ] [ Designated as safety issue: No ]

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

    negativity from baseline to Week 12


  • Number of Participants With Sustained Virologic Response (SVR) [ Time Frame: 24 weeks post-treatment (Week 48 or 72, depending on genotype) ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT

  • Number of HCV-RNA Negative Participants at Follow-up [ Time Frame: 24 weeks post-treatment (Weeks 48 or 72, depending on genotype) ] [ Designated as safety issue: No ]
    HCV-RNA was measured by PCR.


Enrollment: 2302
Study Start Date: August 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: SCH 18908

  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

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00727311     History of Changes
Other Study ID Numbers: P04538
Study First Received: July 30, 2008
Results First Received: December 22, 2010
Last Updated: April 28, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 16, 2014