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

July 30, 2008
April 28, 2014
August 2005
June 2009   (final data collection date for primary outcome measure)
  • 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.
  • Proportion of HCV-RNA negative patients at week 12 of treatment and proportion of patients showing an early virologic response [EVR] (criteria: > 2log reduction in viral load but not HCV-RNA negative at week 12 of treatment) [ Time Frame: At Treatment Week 12 ] [ Designated as safety issue: No ]
  • Sustained virologic response among patients who were already HCV-RNA negative at Treatment Week 12 and among patients who were only 2 log-responders at Treatment Week 12 [ Time Frame: Measured at 24 weeks post-treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00727311 on ClinicalTrials.gov Archive Site
Not Provided
Rate of serious adverse events [ Time Frame: From the signing of the informed consent until 30 days after the end of the study or discontinuation from the study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED)
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Hepatitis C, Chronic
  • Hepatitis C
  • 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
PegIntron + Rebetol
Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy
Interventions:
  • Biological: PegIntron (peginterferon alfa-2b; SCH 54031) injector
  • Drug: Rebetol (ribavirin; SCH 18908)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2302
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00727311
P04538
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP