Hepatitis C Clinical Trial
Official title:
A Phase I/IIa Dose Escalation Study of Repeated Administration of "CYT107" (Glyco-r-hIL-7) Add-On Treatment in Genotype 1 or 4 Hcv Infected Patients Resistant to Pegylated Interferon-Alpha and Ribavirin
This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with standard bi-therapy in patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone.
This is a Phase I/IIa inter-patient dose-escalation study assessing weekly doses of
Interleukin-7 (CYT107) in adult patients infected by virus genotype 1 or 4 of Hepatitis C
and resistant to standard treatment with Peg-Interferon and Ribavirin (bitherapy).
The dose escalation is aimed at establishing the safety of a biologically active doses of
CYT107 added to the combination therapy of pegylated interferon-alpha and ribavirin. At each
dose level, study patients will receive one subcutaneous administration of CYT107 per week
for a total of 4.
Groups of 6 patients will be entered at each dose level of CYT107. Three dose levels are
planned.
Eligible patients initially receive bi-therapy for 6-10 weeks. Thereafter, CYT107 is added
for a cycle of four weekly injections at a defined dose level while standard bi-therapy
continues for 9 weeks after CYT107 treatment discontinuation. The patients are then followed
on a regular basis until reaching 48 weeks after the CYT107 treatment. The duration of study
is approximatively 60 weeks with 20-25 weeks of bi-therapy.
Participants will have 1 overnight hospitalization and 15 clinic visit on a period of 60
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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