A Phase 1/2 interventional study of Interleukin-7 in Hepatitis C, sponsored by Cytheris SA. Status unknown at 8 sites in 3 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 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:
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's planned enrollment of 18 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Cytheris SA is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin defined as:
Exclusion Criteria:
Drug: Interleukin-7
3 dose levels: 3, 10 \& 20 µg/kg. 4 administrations, 1 per week
To evaluate at W 12 the safety of biologically active doses of CYT107 added to a combination therapy by pegylated interferon-alpha and ribavirin
Time frame: 12 weeks after the start of IL-7
To characterize pharmacokinetics and pharmacodynamics of CYT107
Time frame: 12 weeks after the start of IL-7
To evaluate in the context of a dose escalation strategy the potential anti-viral effect of CYT107
Time frame: 12 weeks after the start of IL-7
To evaluate the immune specific response to HCV
Time frame: 12 weeks after the start of IL-7
To document the long-term safety and viral load variations
Time frame: 48 weeks after the start of IL-7
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