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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01025297
Recruitment Status : Unknown
Verified October 2012 by Cytheris SA.
Recruitment status was:  Active, not recruiting
First Posted : December 3, 2009
Last Update Posted : October 18, 2012
Information provided by (Responsible Party):
Cytheris SA

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C Drug: Interleukin-7 Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To characterize pharmacokinetics and pharmacodynamics of CYT107 [ Time Frame: 12 weeks after the start of IL-7 ]
  2. 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 ]
  3. To evaluate the immune specific response to HCV [ Time Frame: 12 weeks after the start of IL-7 ]
  4. To document the long-term safety and viral load variations [ Time Frame: 48 weeks after the start of IL-7 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01025297

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Hopital Jean Verdier
Bondy, France
Beaujon Hospital
Clichy, France
Hopital Kremlin Bicêtre
Kremlin Bicêtre, France
Hopital Civil
Strasbourg, France
Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi
Bologna, Italy
Fatebenefratelli e Oftalmico
Milano, Italy
San Raffaele Scientific Institute
Milano, Italy
University of Zurich
Zurich, Switzerland
Sponsors and Collaborators
Cytheris SA
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Study Chair: Tilman Gerlach Hospital of San Gallen-Switzerland
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Responsible Party: Cytheris SA Identifier: NCT01025297    
Other Study ID Numbers: CLI-107-07
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: October 18, 2012
Last Verified: October 2012
Keywords provided by Cytheris SA:
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:
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Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections