Overview

This trial is active, not recruiting.

Condition hepatitis c
Treatment interleukin-7
Phase phase 1/phase 2
Sponsor Cytheris SA
Start date July 2008
End date December 2012
Trial size 18 participants
Trial identifier NCT01025297, CLI-107-07

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
interleukin-7
3 dose levels: 3, 10 & 20 µg/kg. 4 administrations, 1 per week

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Genotype 1 or 4 infected patients - Age > 18 years - Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin defined as: - Absence of early viral response (EVR) with detectable HCV and with a decrease HCV RNA load < 2 logs, measured by a quantitative PCR tests after 12 weeks of treatment, as compared to baseline levels measured by a similar technique; or - Absence of end of treatment response defined by detectable HCV RNA at the end of treatment (24 weeks or 48 weeks) - Metavir ≤ F3 assessed by biopsy in the last 12 months or by fibroscan if Fibroscan® result < 10 kPa in the last 6 months (biopsy can be avoided) Exclusion Criteria: - Active infection by HBV (positive HBs Ag or positive anti HBc antibodies with a detectable HBV DNA viral load). - Infection by HIV-1 and /or HIV-2 - Apart from HCV infection, presence of active infection requiring a specific treatment or a hospitalization - Other liver disease (notably from alcoholic, metabolic or immunological origin) - Body mass index (BMI) > 30kg/m2 - Relapse after previous response to pegylated IFN alpha and ribavirin therapy - Any history of malignancy apart from curatively treated basal cell carcinoma or in situ cervical carcinoma - History of clinical autoimmune disease or active auto-immune disease - History of severe asthma, presently on chronic medications - Significant cardiac or pulmonary disease - Prior solid organ or hematopoietic cell transplantation - Dialyzed patient - Inability to give informed consent

Additional Information

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
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Cytheris SA.