Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:21 PM
Study NCT ID:
NCT01024894
Status:
UNKNOWN
Last Update Posted:
2012-10-18
First Post:
2009-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in Asiatic HCV Patients Resistant to Bitherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015851', 'term': 'Interleukin-7'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-17', 'studyFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2009-12-02', 'lastUpdatePostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': '12 weeks after start of CYT107'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics and pharmacodynamics of CYT107 in this patients population.', 'timeFrame': 'At short and mid terms follow-ups'}, {'measure': 'potential anti-viral effect of CYT107', 'timeFrame': '4 weeks and 12 weeks after start of CYT107'}, {'measure': 'long-term safety and viral load variations', 'timeFrame': '24 and 48 weeks after the start of CYT107'}, {'measure': 'immune specific response to HCV', 'timeFrame': '8 and 12 weeks after start of CYT107'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['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'], 'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nThe 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.\n\nGroups of 3 to 6 patients will be entered at each dose level of CYT107. Three dose levels are planned.\n\nEligible 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.\n\nParticipants will have 1 overnight hospitalization and 15 clinic visit on a period of 60 weeks.\n\nDuring the visits the following may be done:\n\n* medical history, physical examination, blood tests\n* electrocardiograms (ECG)\n* chest X-Ray\n* liver/spleen imaging\n* urine tests'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* HCV Genotype 1 infected patients\n* Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin\n* Metavir ≤ F3 assessed by biopsy in the last 12 months\n\nMain Exclusion Criteria:\n\n* Active infection by HBV\n* Infection by HIV-1 and /or HIV-2\n* Apart from HCV infection, presence of active infection requiring a specific treatment or a hospitalization\n* Other liver disease\n* Body mass index (BMI) \\> 30kg/m2\n* Relapse after previous response to pegylated IFN alpha and ribavirin therapy\n* Previous bi-therapy with pegylated IFN alpha and ribavirin not well tolerated (in particular treatment discontinuation)\n* Any history of malignancy apart from curatively treated basal cell carcinoma or in situ cervical carcinoma\n* History of clinical autoimmune disease or active auto-immune disease\n* History of severe asthma, presently on chronic medications\n* Significant cardiac or pulmonary disease\n* Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT01024894', 'acronym': 'ECLIPSE 3', 'briefTitle': 'Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in Asiatic HCV Patients Resistant to Bitherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytheris SA'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CLI-107-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CYT107', 'interventionNames': ['Drug: Interleukin-7']}], 'interventions': [{'name': 'Interleukin-7', 'type': 'DRUG', 'description': '3 dose levels: 3, 10 \\& 20 µg/kg. 4 administrations, 1 per week', 'armGroupLabels': ['CYT107']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Chi Mei Medical Center', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10650', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Cathay General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '33305', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Wang-Long Chuang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kaohsiung Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cytheris SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}