Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in Asiatic HCV Patients Resistant to Bitherapy

Hepatitis C Clinical Trial

— ECLIPSE 3  

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: Active, not recruiting

Administrative data

• NCT number: NCT01024894
• Other study ID #: CLI-107-09
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: December 2, 2009
• Last updated: October 17, 2012
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: October 2012
• Source: Cytheris SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

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

Description:

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

Groups of 3 to 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

• HCV Genotype 1 infected patients

• Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin

• Metavir = F3 assessed by biopsy in the last 12 months

Main Exclusion Criteria:

• Active 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

• Other liver disease

• Body mass index (BMI) > 30kg/m2

• Relapse after previous response to pegylated IFN alpha and ribavirin therapy

• Previous bi-therapy with pegylated IFN alpha and ribavirin not well tolerated (in particular treatment discontinuation)

• 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

• Inability to give informed consent

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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	Chi Mei Medical Center	Tainan
Taiwan	Cathay General Hospital	Taipe
Taiwan	Chang Gung Memorial Hospital	Taipe

Sponsors (1)

Lead Sponsor	Collaborator
Cytheris SA

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety of biologically active doses of CYT107 added to a combination therapy by pegylated interferon-alpha and ribavirin in Asian patients with a chronic infection by a genotype 1 HCV not responding to this combination therapy		12 weeks after start of CYT107	Yes
Secondary	Pharmacokinetics and pharmacodynamics of CYT107 in this patients population.		At short and mid terms follow-ups	No
Secondary	potential anti-viral effect of CYT107		4 weeks and 12 weeks after start of CYT107	No
Secondary	long-term safety and viral load variations		24 and 48 weeks after the start of CYT107	Yes
Secondary	immune specific response to HCV		8 and 12 weeks after start of CYT107	No