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

Sponsor

Cytheris SA (Industry)

Overall Status

Completed

CT.gov ID

NCT01025596

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

1.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 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 :

May 1, 2007

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CYT107	Drug: Interleukin-7 4dose levels: 3, 10, 20 and 30µg/kg. 4 administrations, 1 per week

Arm

Intervention/Treatment

Experimental: CYT107

Drug: Interleukin-7

4dose levels: 3, 10, 20 and 30µg/kg. 4 administrations, 1 per week

Outcome Measures

Primary Outcome Measures

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. [8 weeks after start of CYT107]

Secondary Outcome Measures

Pharmacokinetics and pharmacodynamics of CYT107 in this patients population. [As primary]
potential anti-viral effect of CYT107 [As primary]
immune specific response to HCV [As primary]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Main Inclusion Criteria:

Genotype I infected patients
Age > 18 years
Absence of early viral response to a first treatment with PEG-interferon-alpha plus ribavirin given for at least 12 weeks. Absence of early viral response (EVR) will be defined as detectable HCV with a decrease HCV RNA load < 2 logs, measured by a quantitative PCR tests, as compared to baseline levels measured by a similar technique
Ongoing treatment by PEG-interferon-alpha plus ribavirin at study entry

Main Exclusion Criteria:

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
Cirrhosis (Metavir F4) assessed by biopsy or FibroScan® or by liver biopsy within the last 6 months prior CYT107 treatment initiation. If assessed by Fibroscan® patients with a result > 10 KPa will be excluded
Other liver disease (notably from alcoholic, metabolic or immunological origin)
Body mass index (BMI) > 30kg/m2
Inability to give informed consent
Administration of growth factors (G-CSF, EPO) within the 12 weeks of the combination therapy

Contacts and Locations

Locations

	Site	City	Country
1	Hopital Jean Verdier	Bondy	France
2	Beaujon Hospital	Clichy	France
3	Hopital Kremlin Bicêtre	Kremlin Bicêtre	France
4	Hopital Civil	Strasbourg	France
5	Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi	Bologna	Italy
6	San Raffaele Scientific Institute	Milano	Italy
7	University of Zurich	Zurich	Switzerland