Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in Asiatic HCV Patients Resistant to Bitherapy (ECLIPSE 3)

October 17, 2012 updated by: Cytheris SA

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Hospital
      • Tainan, Taiwan
        • Chi Mei Medical Center
      • Taipe, Taiwan, 10650
        • Cathay General Hospital
      • Taipe, Taiwan, 33305
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CYT107
Drug: Interleukin-7
3 dose levels: 3, 10 & 20 µg/kg. 4 administrations, 1 per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 12 weeks after start of CYT107
12 weeks after start of CYT107

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics and pharmacodynamics of CYT107 in this patients population.
Time Frame: At short and mid terms follow-ups
At short and mid terms follow-ups
potential anti-viral effect of CYT107
Time Frame: 4 weeks and 12 weeks after start of CYT107
4 weeks and 12 weeks after start of CYT107
long-term safety and viral load variations
Time Frame: 24 and 48 weeks after the start of CYT107
24 and 48 weeks after the start of CYT107
immune specific response to HCV
Time Frame: 8 and 12 weeks after start of CYT107
8 and 12 weeks after start of CYT107

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytheris SA

Investigators

  • Study Chair: Wang-Long Chuang, MD, Kaohsiung Medical University Hospital,Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (Estimate)

December 3, 2009

Study Record Updates

Last Update Posted (Estimate)

October 18, 2012

Last Update Submitted That Met QC Criteria

October 17, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLI-107-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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