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

October 17, 2012 updated by: Cytheris SA

A Phase Randomized Open Labelled Controlled Dose Escalation Study of Repeated Administration of "CYT107" (Glyco-r-hIL-7) Added on Antiviral Treatment and Vaccination in HBeAg-negative Chronic Hepatitis B-infected Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a Phase I/IIa inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in HBeAg-negative chronic hepatitis B infected adult patients. The dose escalation is aimed at establishing the safety of a biologically active doses of CYT107 added to the current antiviral therapy with entecavir or tenofovir and vaccination or not. At each dose level, study patients will receive one subcutaneous administration of CYT107 per week for a total of 4.

Groups of 8 patients will be entered at each dose level of CYT107. Three dose levels are planned.

At each dose level, patients are randomized between 2 arms of treatment: tritherapy (CYT107, vaccine and antiviral treatment) or bitherapy (CYT107 and vaccine). Each treatment group is composed of 4 patients, 3 receiving experimental treatments, 1 just the current antiviral treatment (control patient).

According to the treatment arm, eligible patients initially receive a vaccine if in treatment group of tritherapy, thereafter, CYT107 is added for a cycle of four weekly injections (if not a control patient) at a defined dose level. If in treatment group of tritherapy, patients will receive 2 additional doses of vaccine.

The treatment phase for the tritherapy group is from first vaccine D0 to last vaccine W12 and includes CYT107 administration from W4 to W7.

The treatment phase for the bitehrapy group is from W4 to W7 corresponding to CYT104 injections.

The patients are then followed on a regular basis until reaching 52 weeks after the D0.

Participants will have 1 overnight hospitalization and 12 clinic visit on a period of 55 weeks.

During the visits the following may be done:

  • medical history, physical examination, blood tests
  • electrocardiograms (ECG)
  • chest X-Ray
  • liver/spleen imaging
  • urine tests

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France
        • Hopital Henri Mendor-Service d'HepatoGastroEnterologie
      • Grenoble, France
        • Hôpital Michallon
      • Lyon, France
        • Hopital de l'Hotel Dieu
      • Marseille, France
        • Hopital Saint Joseph
      • Nice, France
        • CHU L'Archet
      • Paris, France
        • Hopital Tenon
      • Strasbourg, France
        • Hôpital Civil
  • Italy
      • Bologna, Italy
        • Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tritherapy: CYT107+ vaccine+ antiviral
Drug: CYT107+GenHevac+entecavir or tenofovir
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
EXPERIMENTAL: Bitherapy: CYT107 + antiviral
Drug: CYT107+ entecavir or tenofovir
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
To characterize the pharmacokinetics and pharmacodynamics of CYT107 in humans chronically infected with HBV.
Time Frame: Week 12
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
Time Frame: Week 12 and Week 52
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
Time Frame: Week 16
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytheris SA

Investigators

  • Study Chair: Christophe Hezode, Hôpital Henri Mondor-Créteil-France
  • Principal Investigator: Pietro Andreone, S. Orsola Malpighi- Bologna-Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ANTICIPATED)

November 1, 2012

Study Completion (ANTICIPATED)

March 1, 2013

Study Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

December 4, 2009

First Posted (ESTIMATE)

December 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 18, 2012

Last Update Submitted That Met QC Criteria

October 17, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLI-107-10
  • 2009-010709-35 (OTHER: EUDRACT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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