A Phase 1/2 interventional study of CYT107+GenHevac+entecavir or tenofovir and CYT107+ entecavir or tenofovir in Chronic Hepatitis B, sponsored by Cytheris SA. Status unknown at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-18.
Sponsored by Cytheris SA · Phase 1/2, Interventional, and Treatment
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:
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 24 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Cytheris SA is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: CYT107+GenHevac+entecavir or tenofovir
Drug: CYT107+ 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
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
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
To characterize the pharmacokinetics and pharmacodynamics of CYT107 in humans chronically infected with HBV.
Time frame: 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
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
This study is status unknown, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Cytheris SA