Trial ID Number: CLI-107-10
Title: Phase I/IIa Randomized Open Label 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
Trial Name: CONVERT (Combination Of InterleukiN-7 and Vaccine with nEw anti-viRals in HBV Treatment)
Countries: France, Italy
Status: Ongoing
Link to Clinical Trial: Clinical Trials.gov
About the CONVERT Study
CONVERT is a randomized open label, controlled multicentre Phase I inter-patient dose escalation study, followed by a Phase IIa extension of 1 or 2 dose levels of CYT107 which have demonstrated safety and sufficient immunological or antiviral activity.
The primary objective of the study is to determine the short and long-term safety and biological activity of CYT107 in patients with a HBeAg-negative chronic hepatitis B virus who have, at screening, undetectable HBV DNA and who have been stable for at least 3 months with antiviral treatment.
At each dose level, two treatment groups will be run in parallel by including cohorts of 4 patients, 3 treated with CYT107 and 1 control patient (not receiving CYT107). The two treatment groups are characterized by the following:
- Tri-therapy group (Group 1): patients will receive HBV vaccine (GenHevac B Pasteur®) + antiviral treatment [BARACLUDE® (entecavir) or VIREAD® (tenofovir)] + CYT107 and one control patient will receive only antiviral treatment (entecavir or tenofovir)
- Bi-therapy group (Group 2): patients will receive antiviral treatment (entecavir or tenofovir) + CYT107 and one control patient will receive antiviral treatment (entecavir or tenofovir) only.
Patients with chronic HBeAg-negative hepatitis will be assessed for study participation if they have undetectable HBV DNA for at least 3 months when treated with entecavir or tenofovir. The antiviral therapy will be continued during the full duration of the study for both groups. All included patients will be followed up to Week 48. The mid-term evaluation of the biological activity will be performed at Week 16.