Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in HCV Genotype 1 or 4 Patients Resistant to Bitherapy Alone (Eclipse 2)
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: Interleukin-7||Phase 1 Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
3 dose levels: 3, 10 & 20 µg/kg. 4 administrations, 1 per week
- 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 ]
- To characterize pharmacokinetics and pharmacodynamics of CYT107 [ Time Frame: 12 weeks after the start of IL-7 ]
- 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 ]
- To evaluate the immune specific response to HCV [ Time Frame: 12 weeks after the start of IL-7 ]
- To document the long-term safety and viral load variations [ Time Frame: 48 weeks after the start of IL-7 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01025297
|Hopital Jean Verdier|
|Hopital Kremlin Bicêtre|
|Kremlin Bicêtre, France|
|Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi|
|Fatebenefratelli e Oftalmico|
|San Raffaele Scientific Institute|
|University of Zurich|
|Study Chair:||Tilman Gerlach||Hospital of San Gallen-Switzerland|