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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)

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

Tracking Information
First Submitted Date  ICMJE December 1, 2009
First Posted Date  ICMJE December 3, 2009
Last Update Posted Date October 18, 2012
Study Start Date  ICMJE May 2007
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
  • Pharmacokinetics and pharmacodynamics of CYT107 in this patients population. [ Time Frame: As primary ]
  • potential anti-viral effect of CYT107 [ Time Frame: As primary ]
  • immune specific response to HCV [ Time Frame: As primary ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Escalation Study of IL-7 and Bi-therapy in HCV Patients Resistant After 12 Weeks of Bi-therapy (ECLIPSE 1)
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE Drug: Interleukin-7
4dose levels: 3, 10, 20 and 30µg/kg. 4 administrations, 1 per week
Study Arms  ICMJE Experimental: CYT107
Intervention: Drug: Interleukin-7
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2012)
10
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2009)
15
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01025596
Other Study ID Numbers  ICMJE CLI-107-05
EudraCT number 2006-006024-20
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cytheris SA
Study Sponsor  ICMJE Cytheris SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Tilman Gerlach University of Zurich / Saint Gallen
PRS Account Cytheris SA
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP