Dose Escalation of Interleukin-1 (IL-7) Added on Antiviral Treatment and Vaccination in HBeAg-negative Chronic Hepatitis B Virus (HBV) Infected Patients

• 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 anti viral therapy and vaccine in patients with Hepatitis B chronic infection.

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

Details

• Lead Sponsor: Cytheris SA
• Treatments: Antiviral Agents; Entecavir; Tenofovir; Vaccines

Criteria

Inclusion Criteria:

• Chronic HBV-infected patients

• HBeAg-negative patients

• Age > 18 years

• Patients with active chronic hepatitis at the start of the antiviral treatment

• Patient with a HBV DNA undetectable (<70 copies/ml) stable for at least 3 months under entecavir or tenofovir treatment.

• Ongoing treatment by entecavir or tenofovir at screening Note: previous treatment with pegylated IFN monotherapy, before the start of entecavir or tenofovir, is acceptable

Exclusion Criteria:

• Infection by HCV

• Infection by HIV-1 and /or HIV-2

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

• Previous treatment by lamivudine and/or nucleosides analogues

• Inactive carrier

• Cirrhosis

• Other liver disease (notably from alcoholic, metabolic or immunological origin)

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

• Type I diabetes mellitus

• Severe asthma, presently on chronic medications