Treatment of Chronic Hepatitis C With PegIntron Injector and Rebetol (Post Marketing Surveillance Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 2,302
- Primary Endpoint
- Number of Participants With Sustained Virologic Response (SVR)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
PegIntron + Rebetol
Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy
Intervention: PegIntron (peginterferon alfa-2b; SCH 54031) injector (Biological)
PegIntron + Rebetol
Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy
Intervention: Rebetol (ribavirin; SCH 18908) (Drug)
Outcomes
Primary Outcomes
Number of Participants With Sustained Virologic Response (SVR)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 24 weeks post-treatment (Weeks 48 or 72, depending on genotype)
HCV-RNA was measured by PCR.
Secondary Outcomes
No secondary outcomes reported