NCT01025596

Dose Escalation Study of IL-7 and Bi-therapy in HCV Patients Resistant After 12 Weeks of Bi-therapy (ECLIPSE 1)

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Cytheris SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Interleukin-7	4dose levels: 3, 10, 20 and 30µg/kg. 4 administrations, 1 per week

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-02-01
• Completion: 2012-03-01
• First posted: 2009-12-03
• Last updated: 2012-10-18

Locations

7 sites across 3 countries: France, Italy, Switzerland