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Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in HCV Genotype 1 or 4 Patients Resistant to Bitherapy Alone (Eclipse 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cytheris SA
ClinicalTrials.gov Identifier:
NCT01025297
First received: December 2, 2009
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  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 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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/IIa Dose Escalation Study of Repeated Administration of "CYT107" (Glyco-r-hIL-7) Add-On Treatment in Genotype 1 or 4 Hcv Infected Patients Resistant to Pegylated Interferon-Alpha and Ribavirin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cytheris SA:

Primary Outcome Measures:
  • To evaluate at W 12 the safety of biologically active doses of CYT107 added to a combination therapy by pegylated interferon-alpha and ribavirin [ Time Frame: 12 weeks after the start of IL-7 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize pharmacokinetics and pharmacodynamics of CYT107 [ Time Frame: 12 weeks after the start of IL-7 ] [ Designated as safety issue: No ]
  • To evaluate in the context of a dose escalation strategy the potential anti-viral effect of CYT107 [ Time Frame: 12 weeks after the start of IL-7 ] [ Designated as safety issue: No ]
  • To evaluate the immune specific response to HCV [ Time Frame: 12 weeks after the start of IL-7 ] [ Designated as safety issue: No ]
  • To document the long-term safety and viral load variations [ Time Frame: 48 weeks after the start of IL-7 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: July 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 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 adult patients infected by virus genotype 1 or 4 of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (bitherapy).

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 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

Inclusion Criteria:

  • Genotype 1 or 4 infected patients
  • Age > 18 years

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

    • Absence of early viral response (EVR) with detectable HCV and with a decrease HCV RNA load < 2 logs, measured by a quantitative PCR tests after 12 weeks of treatment, as compared to baseline levels measured by a similar technique; or
    • Absence of end of treatment response defined by detectable HCV RNA at the end of treatment (24 weeks or 48 weeks)
  • Metavir ≤ F3 assessed by biopsy in the last 12 months or by fibroscan if Fibroscan® result < 10 kPa in the last 6 months (biopsy can be avoided)

Exclusion Criteria:

  • Active infection by HBV (positive HBs Ag or positive anti HBc antibodies with a detectable HBV DNA viral load).
  • 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 (notably from alcoholic, metabolic or immunological origin)
  • Body mass index (BMI) > 30kg/m2
  • Relapse after previous response to pegylated IFN alpha and ribavirin therapy
  • 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
  • Prior solid organ or hematopoietic cell transplantation
  • Dialyzed patient
  • Inability to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025297

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
Fatebenefratelli e Oftalmico
Milano, Italy
Switzerland
University of Zurich
Zurich, Switzerland
Sponsors and Collaborators
Cytheris SA
Investigators
Study Chair: Tilman Gerlach Hospital of San Gallen-Switzerland
  More Information

No publications provided

Responsible Party: Cytheris SA
ClinicalTrials.gov Identifier: NCT01025297     History of Changes
Other Study ID Numbers: CLI-107-07
Study First Received: December 2, 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

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 1/2a
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 May 16, 2013