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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01025596
• Date of registration: 01/12/2009
• Prospective Registration: No
• Primary sponsor: Cytheris SA
• Public title: Dose Escalation Study of IL-7 and Bi-therapy in HCV Patients Resistant After 12 Weeks of Bi-therapy (ECLIPSE 1) ECLIPSE 1
• Scientific 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
• Date of first enrolment: May 2007
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01025596
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

France, Italy, Switzerland

Contacts

• Name: Tilman Gerlach
• Affiliation: University of Zurich / Saint Gallen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis C

Intervention(s)

Drug: Interleukin-7

Primary Outcome(s)

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. [Time Frame: 8 weeks after start of CYT107]

Secondary Outcome(s)

Pharmacokinetics and pharmacodynamics of CYT107 in this patients population. [Time Frame: As primary]

potential anti-viral effect of CYT107 [Time Frame: As primary]

immune specific response to HCV [Time Frame: As primary]

Secondary ID(s)

EudraCT number 2006-006024-20

CLI-107-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors