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

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: NCT01025596
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : October 18, 2012
Information provided by (Responsible Party):
Cytheris SA

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2007
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CYT107 Drug: Interleukin-7
4dose levels: 3, 10, 20 and 30µg/kg. 4 administrations, 1 per week

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetics and pharmacodynamics of CYT107 in this patients population. [ Time Frame: As primary ]
  2. potential anti-viral effect of CYT107 [ Time Frame: As primary ]
  3. immune specific response to HCV [ Time Frame: As primary ]

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

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

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): NCT01025596

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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
San Raffaele Scientific Institute
Milano, Italy
University of Zurich
Zurich, Switzerland
Sponsors and Collaborators
Cytheris SA
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Study Chair: Tilman Gerlach University of Zurich / Saint Gallen
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Responsible Party: Cytheris SA Identifier: NCT01025596    
Other Study ID Numbers: CLI-107-05
EudraCT number 2006-006024-20
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
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