Dose Escalation Study of IL-7 and Bi-therapy in HCV Patients Resistant After 12 Weeks of Bi-therapy (ECLIPSE 1)
This study will evaluate the safety of a new experimental drug, IL-7, in people with HCV infection resistant after 12 weeks of bi-therapy.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PHASE I/IIa DOSE ESCALATION STUDY IN ASIA OF REPEATED ADMINISTRATION OF "CYT107" (Glyco-r-hIL-7) ADDED ON TREATMENT IN GENOTYPE 1 HCV INFECTED PATIENTS RESISTANT TO PEGYLATED INTERFERON-ALPHA AND RIBAVIRIN|
- Safety of biologically active doses of CYT107 added to a standard bi-therapy in patients with a chronic infection by a genotype 1 Hepatitis C Virus (HCV) not responding to this combination therapy 12 weeks after its initiation. [ Time Frame: 8 weeks after start of CYT107 ] [ Designated as safety issue: Yes ]
- Pharmacokinetics and pharmacodynamics of CYT107 in this patients population. [ Time Frame: As primary ] [ Designated as safety issue: No ]
- potential anti-viral effect of CYT107 [ Time Frame: As primary ] [ Designated as safety issue: No ]
- immune specific response to HCV [ Time Frame: As primary ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||March 2012|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
4dose levels: 3, 10, 20 and 30µg/kg. 4 administrations, 1 per week
This is a Phase I inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in adult patients infected by Genotype 1 Virus of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (biotherapy)after 12 weeks of this standard bi-therapy.
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 a subcutaneous administration of CYT107 per week for a total of 4 administrations.
Groups of 3 to 6 patients will be entered at each dose level of CYT107. Four dose levels are planned.
Eligible patients will a cycle of four weekly injections at a defined dose level in addition to the bi-therapy. Standard bi-therapy will continue 4 weeks after CYT107 treatment discontinuation. The duration of study is approximately 11 weeks including screening period.
Participants have 1 hospitalization overnight and 8 clinic visits. The four administrations are sub-cutaneous and are given as a shot under the skin in the arm or abdomen or leg.
During the study visits the following may be done:
- Medical history, physical examination, blood tests every visit.
- Electrocardiogram (EKG)
- Chest x-ray study
- Liver/spleen imaging
- Blood sample collections at frequent intervals
- Urine tests several times during the study.
|Hopital Jean Verdier|
|Hopital Kremlin Bicêtre|
|Kremlin Bicêtre, France|
|Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi|
|San Raffaele Scientific Institute|
|University of Zurich|
|Study Chair:||Tilman Gerlach||University of Zurich / Saint Gallen|