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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis C, Hepatitis C, Chronic

Intervention / Treatment
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* Biological: PegIntron (peginterferon alfa-2b; SCH 54031) injector
* Drug: Rebetol (ribavirin; SCH 18908)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PegIntron + Rebetol<br>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<br>* PegIntron administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling<br>* Other names: SCH 54031;Drug: Rebetol (ribavirin; SCH 18908)<br>* Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling<br>* Other names: SCH 18908;|

What is the study measuring?
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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) | 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) | 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) | 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 | HCV-RNA was measured by PCR. | 24 weeks post-treatment (Weeks 48 or 72, depending on genotype) |