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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727311
• Other study ID #: P04538
• Status: Completed
• Phase: N/A
• First received: July 30, 2008
• Last updated: October 8, 2015
• Start date: August 2005
• Est. completion date: June 2009

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2302
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• PegIntron (peginterferon alfa-2b; SCH 54031) injector
PegIntron administered at a dose 1.5 µg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling

Drug:
• Rebetol (ribavirin; SCH 18908)
Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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)	No
Primary	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)	No