Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-01-02 @ 4:47 AM
Study NCT ID:
NCT00352235
Status:
COMPLETED
Last Update Posted:
2006-07-14
First Post:
2006-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'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': 'C103873', 'term': 'KRN 7000'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2005-05'}, 'lastUpdateSubmitDate': '2006-07-13', 'studyFirstSubmitDate': '2006-07-13', 'studyFirstSubmitQcDate': '2006-07-13', 'lastUpdatePostDateStruct': {'date': '2006-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in serum hepatitis C virus ribonucleic acid (HCV RNA) levels.'}], 'secondaryOutcomes': [{'measure': 'Normalization of serum ALT levels.'}, {'measure': 'Effect on serum cytokines IFNg and TNFa and on iNKT cells.'}]}, 'conditionsModule': {'keywords': ['Chronic hepatitis C', 'KRN7000', 'a-GalCer', 'immunotherapy', 'Natural Killer T cells', 'interferon'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'Phase I/II trial of KRN7000 in patients with chronic hepatitis C.\n\nStudy objectives: To evaluate and compare the safety and tolerability of 3 ascending doses of a-GalCer.\n\nThe primary efficacy parameter: HCV-RNA response at the end of treatment. Secondary efficacy parameter: Serum ALT response. Further objectives of the study are to evaluate the effect of a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells.\n\nNumber of dose levels: 3 Investigational product: KRN7000 Route of administration: intravenous Dosages and frequency: 0.1, 1, 10 mcg/kg, monthly injection, 3 times (day 0, day 28 and day 56)', 'detailedDescription': 'Phase I/II trial of KRN7000 in patients with chronic hepatitis C.\n\nThis study is a multicenter double-blind randomized placebo-controlled phase I/II dose-escalation trial. The protocol is conducted in The Netherlands, Belgium and Germany. Patients with chronic hepatitis C who met the inclusion criteria are assigned to receive a-GalCer (KRN7000 ((2S, 3S, 4R)-1-O-(a-D-galactopyranosyl)-N-hexacosanoyl-2-amino-1,3,4-octadecanetriol), Kirin Pharmaceutical Co., Ltd., Gunma, Japan) or placebo intravenously, thrice with intervals of 4 weeks. Cohorts of 12 patients are entered at each of the three dose levels (0.1, 1 and 10 mg/kg body weight). Three patients per dose level are randomized to the placebo arm.\n\nDose escalation to the next cohort are decided after evaluation by a safety review board of all the safety data collected on all the patients who had completed 3 weeks after the first injection in the preceding dose cohort. After completion of 8 weeks of treatment, with injections at 0, 4 and 8 weeks, patients are monitored without further therapy for an additional 16 weeks.\n\nStudy objectives: The objective of the study is to evaluate and compare the safety and tolerability of 3 ascending doses of a-GalCer. The primary efficacy parameter is the response at the end of treatment, based on serum hepatitis C virus ribonucleic acid (HCV RNA) levels. As a secondary efficacy parameter serum ALT levels are evaluated. Further objectives of the study are to evaluate the effect of a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChronic hepatitis C Liver biopsy within 3 years of entry into the study HCV RNA \\> 10000 copies/mL Age 18-70 years ALT \\> 1.2 times ULN written informed consent Adequate contraception\n\nExclusion Criteria:\n\nCirrhosis Decompensated liver disease ALT \\> 10 times ULN Pregnancy Major other illness'}, 'identificationModule': {'nctId': 'NCT00352235', 'briefTitle': 'Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection', 'organization': {'class': 'OTHER', 'fullName': 'Foundation for Liver Research'}, 'officialTitle': 'Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection', 'orgStudyIdInfo': {'id': 'KRN7000 HCV'}}, 'armsInterventionsModule': {'interventions': [{'name': 'KRN7000', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000CA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Carin MJ van Nieuwkerk, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VU medical Center, Amsterdam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation for Liver Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}]}}}