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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Cytheris SA.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Cytheris SA
ClinicalTrials.gov Identifier:
NCT01027065
First received: December 4, 2009
Last updated: October 17, 2012
Last verified: October 2012

December 4, 2009
October 17, 2012
December 2009
November 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01027065 on ClinicalTrials.gov Archive Site
  • To characterize the pharmacokinetics and pharmacodynamics of CYT107 in humans chronically infected with HBV. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose Escalation of Interleukin-1 (IL-7) Added on Antiviral Treatment and Vaccination in HBeAg-negative Chronic Hepatitis B Virus (HBV) Infected Patients
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.

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
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
  • 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
  • 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
  • Experimental: Tritherapy: CYT107+ vaccine+ antiviral
    Intervention: Drug: CYT107+GenHevac+entecavir or tenofovir
  • Experimental: Bitherapy: CYT107 + antiviral
    Intervention: Drug: CYT107+ entecavir or tenofovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
March 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy,   France
 
NCT01027065
CLI-107-10, 2009-010709-35
Yes
Cytheris SA
Cytheris SA
Not Provided
Study Chair: Christophe Hezode Hopital Henri Mondor-Créteil-France
Principal Investigator: Pietro Andreone S. Orsola Malpighi- Bologna-Italy
Cytheris SA
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP