Dose Escalation of Interleukin-1 (IL-7) Added on Antiviral Treatment and Vaccination in HBeAg-negative Chronic Hepatitis B Virus (HBV) Infected Patients
NCT ID: NCT01027065
Last Updated: 2012-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2009-12-31
2013-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tritherapy: CYT107+ vaccine+ antiviral
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
Bitherapy: CYT107 + antiviral
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Cytheris SA
INDUSTRY
Responsible Party
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Principal Investigators
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Christophe Hezode
Role: STUDY_CHAIR
Hopital Henri Mondor-Créteil-France
Pietro Andreone
Role: PRINCIPAL_INVESTIGATOR
S. Orsola Malpighi- Bologna-Italy
Locations
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Hopital Henri Mendor-Service d'HepatoGastroEnterologie
Créteil, , France
Hopital Michallon
Grenoble, , France
Hopital de l'Hotel Dieu
Lyon, , France
Hopital Saint Joseph
Marseille, , France
CHU l'Archet
Nice, , France
Hopital Tenon
Paris, , France
Hopital Civil
Strasbourg, , France
Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Countries
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Other Identifiers
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2009-010709-35
Identifier Type: OTHER
Identifier Source: secondary_id
CLI-107-10
Identifier Type: -
Identifier Source: org_study_id