Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in HCV Genotype 1 or 4 Patients Resistant to Bitherapy Alone

NCT ID: NCT01025297

Last Updated: 2012-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2013-03-31

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

Detailed Description

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

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 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

Conditions

Hepatitis C

Keywords

interleukin-7; immune-based therapies; hepatitis C; chronic hepatitis; resistance to Peg-interferon and ribavirin bi-therapy; immune specific responses to HCV; phase 1/2a; viral disease; liver disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CYT107

Group Type: EXPERIMENTAL

Interleukin-7

Intervention Type: DRUG

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

Interventions

Interleukin-7

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Genotype 1 or 4 infected patients
• Age > 18 years
• Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin defined as:

• Absence of early viral response (EVR) with detectable HCV and with a decrease HCV RNA load < 2 logs, measured by a quantitative PCR tests after 12 weeks of treatment, as compared to baseline levels measured by a similar technique; or
• Absence of end of treatment response defined by detectable HCV RNA at the end of treatment (24 weeks or 48 weeks)
• Metavir ≤ F3 assessed by biopsy in the last 12 months or by fibroscan if Fibroscan® result < 10 kPa in the last 6 months (biopsy can be avoided)

Exclusion Criteria

• Active infection by HBV (positive HBs Ag or positive anti HBc antibodies with a detectable HBV DNA viral load).
• 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 (notably from alcoholic, metabolic or immunological origin)
• Body mass index (BMI) > 30kg/m2
• Relapse after previous response to pegylated IFN alpha and ribavirin therapy
• 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
• Prior solid organ or hematopoietic cell transplantation
• Dialyzed patient
• Inability to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytheris SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tilman Gerlach

Role: STUDY_CHAIR

Hospital of San Gallen-Switzerland

Locations

Hopital Jean Verdier

Bondy, , France

Beaujon Hospital

Clichy, , France

Hopital Kremlin Bicêtre

Le Kremlin-Bicêtre, , France

Hopital Civil

Strasbourg, , France

Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi

Bologna, , Italy

Fatebenefratelli e Oftalmico

Milan, , Italy

San Raffaele Scientific Institute

Milan, , Italy

University of Zurich

Zurich, , Switzerland

Countries

France; Italy; Switzerland

Other Identifiers

CLI-107-07

Identifier Type: -

Identifier Source: org_study_id