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
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: 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 August 21, 2014