Trial | NCT01025596  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    il-7 ...

  • Study Participants

    10
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.
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 Started
May 31
2007
Primary Completion
Feb 28
2011
Study Completion
Mar 31
2012
Last Update
Oct 18
2012
Estimate

Drug Interleukin-7

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

CYT107 Experimental

Criteria 

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
No Results Posted