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

Hepatitis C Clinical Trial

— ECLIPSE 1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025596
• Other study ID #: CLI-107-05
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 1, 2009
• Last updated: October 17, 2012
• Start date: May 2007
• Est. completion date: March 2012

Study information

• Verified date: October 2012
• Source: Cytheris SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: The Italian Medicines AgencySwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• Interleukin-7
4dose levels: 3, 10, 20 and 30µg/kg. 4 administrations, 1 per week

Locations

Country	Name	City	State
France	Hopital Jean Verdier	Bondy
France	Beaujon Hospital	Clichy
France	Hopital Kremlin Bicêtre	Kremlin Bicêtre
France	Hopital Civil	Strasbourg
Italy	Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi	Bologna
Italy	San Raffaele Scientific Institute	Milano
Switzerland	University of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Cytheris SA

Countries where clinical trial is conducted

France,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pharmacokinetics and pharmacodynamics of CYT107 in this patients population.		As primary	No
Secondary	potential anti-viral effect of CYT107		As primary	No
Secondary	immune specific response to HCV		As primary	No