Clinical trial NCT00727311: Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED)
Official title: Treatment of Chronic Hepatitis C With PegIntron Injector and Rebetol (Post Marketing Surveillance Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-01
Enrollment: 2302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)
timeFrame: 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6
measure: Number of Participants With Early Virologic Response (EVR)
timeFrame: Treatment Week 12
measure: Number of Participants With Sustained Virologic Response (SVR)
timeFrame: 24 weeks post-treatment (Week 48 or 72, depending on genotype)
measure: Number of HCV-RNA Negative Participants at Follow-up
timeFrame: 24 weeks post-treatment (Weeks 48 or 72, depending on genotype)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: