Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in Asiatic HCV Patients Resistant to Bitherapy

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with standard bi-therapy in Asiatic patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cytheris SA
• Treatments: Interferons; Ribavirin

Criteria

Main Inclusion Criteria:

• HCV Genotype 1 infected patients

• Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin

• Metavir ≤ F3 assessed by biopsy in the last 12 months

Main Exclusion Criteria:

• Active infection by HBV

• Infection by HIV-1 and /or HIV-2

• Apart from HCV infection, presence of active infection requiring a specific treatment or a hospitalization

• Other liver disease

• Body mass index (BMI) > 30kg/m2

• Relapse after previous response to pegylated IFN alpha and ribavirin therapy

• Previous bi-therapy with pegylated IFN alpha and ribavirin not well tolerated (in particular treatment discontinuation)

• Any history of malignancy apart from curatively treated basal cell carcinoma or in situ cervical carcinoma

• History of clinical autoimmune disease or active auto-immune disease

• History of severe asthma, presently on chronic medications

• Significant cardiac or pulmonary disease

• Inability to give informed consent