Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT01024894
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 Asiatic patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone.
Detailed Description:
This is a Phase I/IIa inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in Asiatic adult patients infected by virus of genotype 1 of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (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 one subcutaneous administration of CYT107 per week for a total of 4.
Groups of 3 to 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:
NCT01024894
Study Brief:
Protocol Section:
NCT01024894