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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Cytheris SA.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Cytheris SA
ClinicalTrials.gov Identifier:
NCT01024894
First received: December 2, 2009
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Interleukin-7
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cytheris SA:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics and pharmacodynamics of CYT107 in this patients population. [ Time Frame: At short and mid terms follow-ups ] [ Designated as safety issue: No ]
  • potential anti-viral effect of CYT107 [ Time Frame: 4 weeks and 12 weeks after start of CYT107 ] [ Designated as safety issue: No ]
  • long-term safety and viral load variations [ Time Frame: 24 and 48 weeks after the start of CYT107 ] [ Designated as safety issue: Yes ]
  • immune specific response to HCV [ Time Frame: 8 and 12 weeks after start of CYT107 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: January 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CYT107 Drug: Interleukin-7
3 dose levels: 3, 10 & 20 µg/kg. 4 administrations, 1 per week

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024894

Locations
Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 807
Chi Mei Medical Center
Tainan, Taiwan
Cathay General Hospital
Taipe, Taiwan, 10650
Chang Gung Memorial Hospital
Taipe, Taiwan, 33305
Sponsors and Collaborators
Cytheris SA
Investigators
Study Chair: Wang-Long Chuang, MD Kaohsiung Medical University Hospital - Taiwan
  More Information

No publications provided

Responsible Party: Cytheris SA
ClinicalTrials.gov Identifier: NCT01024894     History of Changes
Other Study ID Numbers: CLI-107-09
Study First Received: December 2, 2009
Last Updated: October 17, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Cytheris SA:
interleukin-7
immune-based therapies
hepatitis C
chronic hepatitis
resistance to Peg-interferon and ribavirin bitherapy
immune specific responses to HCV
taiwan
phase 1/2a
viral disease
liver disease

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014