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

Recruitment & Eligibility

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 & Design

Arm && Interventions

Group	Intervention	Description
PegIntron + Rebetol	Rebetol (ribavirin; SCH 18908)	Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy
PegIntron + Rebetol	PegIntron (peginterferon alfa-2b; SCH 54031) injector	Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy

Primary Outcome Measures

Name	Time	Method
Number of Participants With Sustained Virologic Response (SVR)	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
Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)	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).
Number of Participants With Early Virologic Response (EVR)	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
Number of HCV-RNA Negative Participants at Follow-up	24 weeks post-treatment (Weeks 48 or 72, depending on genotype)	HCV-RNA was measured by PCR.

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility