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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cytheris SA
ClinicalTrials.gov Identifier:
NCT01025596
First received: December 1, 2009
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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.


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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics and pharmacodynamics of CYT107 in this patients population. [ Time Frame: As primary ] [ Designated as safety issue: No ]
  • potential anti-viral effect of CYT107 [ Time Frame: As primary ] [ Designated as safety issue: No ]
  • immune specific response to HCV [ Time Frame: As primary ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: May 2007
Study Completion Date: March 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CYT107 Drug: Interleukin-7
4dose levels: 3, 10, 20 and 30µg/kg. 4 administrations, 1 per week

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025596

Locations
France
Hopital Jean Verdier
Bondy, France
Beaujon Hospital
Clichy, France
Hopital Kremlin Bicêtre
Kremlin Bicêtre, France
Hopital Civil
Strasbourg, France
Italy
Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi
Bologna, Italy
San Raffaele Scientific Institute
Milano, Italy
Switzerland
University of Zurich
Zurich, Switzerland
Sponsors and Collaborators
Cytheris SA
Investigators
Study Chair: Tilman Gerlach University of Zurich / Saint Gallen
  More Information

No publications provided

Responsible Party: Cytheris SA
ClinicalTrials.gov Identifier: NCT01025596     History of Changes
Other Study ID Numbers: CLI-107-05, EudraCT number 2006-006024-20
Study First Received: December 1, 2009
Last Updated: October 17, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency
Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on April 16, 2014