Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in Asiatic HCV Patients Resistant to Bitherapy (ECLIPSE 3)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Drug: Interleukin-7 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- safety of biologically active doses of CYT107 added to a combination therapy by pegylated interferon-alpha and ribavirin in Asian patients with a chronic infection by a genotype 1 HCV not responding to this combination therapy [ Time Frame: 12 weeks after start of CYT107 ] [ Designated as safety issue: Yes ]
- Pharmacokinetics and pharmacodynamics of CYT107 in this patients population. [ Time Frame: At short and mid terms follow-ups ] [ Designated as safety issue: No ]
- potential anti-viral effect of CYT107 [ Time Frame: 4 weeks and 12 weeks after start of CYT107 ] [ Designated as safety issue: No ]
- long-term safety and viral load variations [ Time Frame: 24 and 48 weeks after the start of CYT107 ] [ Designated as safety issue: Yes ]
- immune specific response to HCV [ Time Frame: 8 and 12 weeks after start of CYT107 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CYT107 |
Drug: Interleukin-7
3 dose levels: 3, 10 & 20 µg/kg. 4 administrations, 1 per week
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
- HCV Genotype 1 infected patients
- Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin
- Metavir ≤ F3 assessed by biopsy in the last 12 months
Main Exclusion Criteria:
- Active 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
- Other liver disease
- Body mass index (BMI) > 30kg/m2
- Relapse after previous response to pegylated IFN alpha and ribavirin therapy
- Previous bi-therapy with pegylated IFN alpha and ribavirin not well tolerated (in particular treatment discontinuation)
- Any history of malignancy apart from curatively treated basal cell carcinoma or in situ cervical carcinoma
- History of clinical autoimmune disease or active auto-immune disease
- History of severe asthma, presently on chronic medications
- Significant cardiac or pulmonary disease
- Inability to give informed consent
Contacts and Locations| Taiwan | |
| Kaohsiung Medical University Hospital | |
| Kaohsiung, Taiwan, 807 | |
| Chi Mei Medical Center | |
| Tainan, Taiwan | |
| Cathay General Hospital | |
| Taipe, Taiwan, 10650 | |
| Chang Gung Memorial Hospital | |
| Taipe, Taiwan, 33305 | |
| Study Chair: | Wang-Long Chuang, MD | Kaohsiung Medical University Hospital - Taiwan |
More Information
No publications provided
| Responsible Party: | Cytheris SA |
| ClinicalTrials.gov Identifier: | NCT01024894 History of Changes |
| Other Study ID Numbers: | CLI-107-09 |
| Study First Received: | December 2, 2009 |
| Last Updated: | October 17, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Cytheris SA:
|
interleukin-7 immune-based therapies hepatitis C chronic hepatitis resistance to Peg-interferon and ribavirin bitherapy |
immune specific responses to HCV taiwan phase 1/2a viral disease liver disease |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 16, 2013