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
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: Interleukin-7||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||March 2012|
4dose levels: 3, 10, 20 and 30µg/kg. 4 administrations, 1 per week
- 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 ]
- 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 ]
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): NCT01025596
|Hopital Jean Verdier|
|Hopital Kremlin Bicêtre|
|Kremlin Bicêtre, France|
|Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi|
|San Raffaele Scientific Institute|
|University of Zurich|
|Study Chair:||Tilman Gerlach||University of Zurich / Saint Gallen|