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Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C; Hepatitis C; HIV Infections

Intervention: PEG-IFN alfa-2b (Biological); RBV (Drug)

Phase: N/A

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

The objective of the study was to assess the safety and efficacy of peginterferon alfa-2b (PEG-IFN alfa-2b) and ribavirin (RBV) administered to participants coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Participants were treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study assessed the rates of eradication of the HCV and the rates of serious adverse events reported with PEG-IFN alfa-2b (1. 5 ug/kg/week) and RBV (800-1200 mg/day) in common medical practice in Germany.

Clinical Details

Official title: Treatment of Chronic Hepatitis C in HIV-infected Patients With PegIntron Pen and Rebetol According to German Law (§ 67 Abs 6 AMG)

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Number of Participants With Sustained Virologic Response (SVR)

Secondary outcome:

Number of Participants With Rapid Virologic Response (RVR)

Number of Participants With Early Virologic Response (EVR)

Participant Study Status at End of Follow-up (EOF)

Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment

Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment

Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment

Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment

Detailed description: In this observational, non-interventional study, the time of enrollment and start of treatment was the sole decision of the physician. No investigational medicinal product was provided by the sponsor.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- ≥ 18 years of age eligible for treatment according to the Summary of Product

Characteristics (SmPC)

- Presence of chronic Hepatitis C (with elevated liver enzymes and without

decompensation)

- Presence of HCV-RNA and known genotype of the infecting hepatitis C virus

- HIV infection confirmed by positive Enzyme Linked Immunosorbent Assay (ELISA) and

Western blot and Cluster of differentiation (CD) 4 cell count >200/mL

- Treatment-naïve

- Platelets ≥ 75,000/mm^3

- Neutrophil counts ≥ 1,500/mm^3

- Thyroid Stimulating Hormone (TSH) must be within normal limits

- Hemoglobin ≥ 10 g/dL (females); ≥ 11 g/dL (males)

- 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 according to the European approval and to the SmPC

- Pretreatment of chronic hepatitis C

- Liver decompensation

- Hypersensitivity to the active substance or to any interferons or to any of the

excipients

- Pregnant woman

- Women who are breast feeding

- Existence of or history of psychiatric condition, particular 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

Locations and Contacts

Additional Information

Starting date: December 2005
Last updated: February 2, 2015

Page last updated: August 23, 2015

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