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

NCT01027065 | Unknown Phase 1 DMC

• 2 other identifiers: CLI-107-102009-010709-35
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 8

Brief 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.

Conditions

Chronic Hepatitis B

Keywords

interleukin-7; immune-based therapies; hepatitis B; HBe negative; HBV vaccination; entecavir; tenofovir; chronic hepatitis; immune specific responses to HBV; phase 1/2a; viral disease; liver disease

Outcome Measures

Primary Outcomes (1)

• To determine the short and long-term safety and biological activity of CYT107 in patients with a HBeAg-negative chronic hepatitis B who have, at screening a HBV DNA undetectable stable for at least 3 months with antiviral treatment.

  Week 12

Secondary Outcomes (3)

• To characterize the pharmacokinetics and pharmacodynamics of CYT107 in humans chronically infected with HBV.

  Week 12

• To assess the effects of the tri-therapy (CYT107 + HBV vaccine + antiviral treatment) versus bi-therapy (CYT107 + antiviral treatment) versus control (antiviral treatment) on the markers of the HBV infection (antiviral activity)at W16 weeks and W52

  Week 12 and Week 52

• To quantify the effects of the tri-therapy (CYT107 + HBV vaccine + antiviral treatment) versus bi-therapy (CYT107 + antiviral treatment) versus control (antiviral treatment) on the immune system at W16 weeks

  Week 16

Study Arms (2)

Tritherapy: CYT107+ vaccine+ antiviral

EXPERIMENTAL

Drug: CYT107+GenHevac+entecavir or tenofovir

Bitherapy: CYT107 + antiviral

EXPERIMENTAL

Drug: CYT107+ entecavir or tenofovir

Interventions

CYT107+GenHevac+entecavir or tenofovir DRUG

4 patients per arm for each dose level. 3 patients receiving experimental treatment (CYT107 and vaccine) in addition to current antiviral treatment and 1 control patient only the current antiviral treatment

Tritherapy: CYT107+ vaccine+ antiviral

CYT107+ entecavir or tenofovir DRUG

4 patients per arm for each dose level. 3 patients receiving experimental treatment (CYT107) in addition to current antiviral treatment and 1 control patient only the current antiviral treatment

Bitherapy: CYT107 + antiviral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytheris SA: lead

Study Sites (8)

Hopital Henri Mendor-Service d'HepatoGastroEnterologie

Créteil, France

Location

Hopital Michallon

Grenoble, France

Location

Hopital de l'Hotel Dieu

Lyon, France

Location

Hopital Saint Joseph

Marseille, France

Location

CHU l'Archet

Nice, France

Location

Hopital Tenon

Paris, France

Location

Hopital Civil

Strasbourg, France

Location

Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi

Bologna, Italy

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B; Hepatitis, Chronic; Virus Diseases; Liver Diseases

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Christophe Hezode

  Hopital Henri Mondor-Créteil-France

  STUDY CHAIR

• Pietro Andreone

  S. Orsola Malpighi- Bologna-Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 7, 2009
• Study Start: December 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: March 1, 2013
• Last Updated: October 18, 2012

Record last verified: 2012-10

Locations

FR (7); IT (1)