Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in HCV Genotype 1 or 4 Patients Resistant to Bitherapy Alone

• Status: Unknown status
• Trial end date: 2013-03-01
• 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 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

Inclusion Criteria:

• Genotype 1 or 4 infected patients

• Age > 18 years

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

• Absence of early viral response (EVR) with detectable HCV and with a decrease HCV RNA load < 2 logs, measured by a quantitative PCR tests after 12 weeks of treatment, as compared to baseline levels measured by a similar technique; or

• Absence of end of treatment response defined by detectable HCV RNA at the end of treatment (24 weeks or 48 weeks)

• Metavir ≤ F3 assessed by biopsy in the last 12 months or by fibroscan if Fibroscan® result < 10 kPa in the last 6 months (biopsy can be avoided)

Exclusion Criteria:

• Active infection by HBV (positive HBs Ag or positive anti HBc antibodies with a detectable HBV DNA viral load).

• 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 (notably from alcoholic, metabolic or immunological origin)

• Body mass index (BMI) > 30kg/m2

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

• 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

• Prior solid organ or hematopoietic cell transplantation

• Dialyzed patient

• Inability to give informed consent