ECLIPSE 3: Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in Asiatic HCV Patients Resistant to Bitherapy

Sponsor

Cytheris SA (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01024894

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

3.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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 Asiatic patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: Interleukin-7	Phase 1/Phase 2

Detailed Description

This is a Phase I/IIa inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in Asiatic adult patients infected by virus of genotype 1 of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (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 one subcutaneous administration of CYT107 per week for a total of 4.

Groups of 3 to 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2009

Anticipated Primary Completion Date :

Nov 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CYT107	Drug: Interleukin-7 3 dose levels: 3, 10 & 20 µg/kg. 4 administrations, 1 per week

Arm

Intervention/Treatment

Experimental: CYT107

Drug: Interleukin-7

3 dose levels: 3, 10 & 20 µg/kg. 4 administrations, 1 per week

Outcome Measures

Primary Outcome Measures

safety of biologically active doses of CYT107 added to a combination therapy by pegylated interferon-alpha and ribavirin in Asian patients with a chronic infection by a genotype 1 HCV not responding to this combination therapy [12 weeks after start of CYT107]

Secondary Outcome Measures

Pharmacokinetics and pharmacodynamics of CYT107 in this patients population. [At short and mid terms follow-ups]
potential anti-viral effect of CYT107 [4 weeks and 12 weeks after start of CYT107]
long-term safety and viral load variations [24 and 48 weeks after the start of CYT107]
immune specific response to HCV [8 and 12 weeks after start of CYT107]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Main Inclusion Criteria:

HCV Genotype 1 infected patients
Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin
Metavir ≤ F3 assessed by biopsy in the last 12 months

Main Exclusion Criteria:

Active infection by HBV
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
Body mass index (BMI) > 30kg/m2
Relapse after previous response to pegylated IFN alpha and ribavirin therapy
Previous bi-therapy with pegylated IFN alpha and ribavirin not well tolerated (in particular treatment discontinuation)
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
Inability to give informed consent

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Kaohsiung Medical University Hospital	Kaohsiung	Taiwan	807
2	Chi Mei Medical Center	Tainan	Taiwan
3	Cathay General Hospital	Taipe	Taiwan	10650
4	Chang Gung Memorial Hospital	Taipe	Taiwan	33305