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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PegIntron (peginterferon alfa-2b; SCH 54031) injector

Biological

PegIntron administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling

Other names: SCH 54031

REBETOL (ribavirin; SCH 18908)

Drug

Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling

Other names: SCH 18908

Primary outcomes

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 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 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2009
Study completion: 2009
First posted: Aug 1, 2008
Registry last updated: Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed