Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT00983060
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2009-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Italy', 'Netherlands', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'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'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C090438', 'term': '(melle-4)cyclosporin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'dispFirstSubmitDate': '2020-08-20', 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2009-09-22', 'dispFirstSubmitQcDate': '2020-08-20', 'studyFirstSubmitQcDate': '2009-09-22', 'dispFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'To identify a dose of NIM811 which is safe and tolerated and produces in combination with SOC a clinically meaningful improvement over SOC monotherapy in antiviral response Time Frame: 4 weeks', 'timeFrame': '12 weeks'}, {'measure': 'To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC', 'timeFrame': '4 weeks'}, {'measure': 'To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1', 'timeFrame': '3 weeks, 5 weeks'}, {'measure': 'To evaluate the effect of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 on sustained virologic response 12 weeks after cessation of treatment (SVR12)', 'timeFrame': '12 weeks after cessation of treatment'}]}, 'conditionsModule': {'keywords': ['NIM811', 'chronic hepatitis', 'chronic hepatitis C', 'chronic hepatitis C genotype-1', 'HCV', 'HCV-1', 'relapser'], 'conditions': ['Chronic Hepatitis C Genotype-1 Relapse']}, 'referencesModule': {'references': [{'pmid': '21255610', 'type': 'RESULT', 'citation': 'Lawitz E, Godofsky E, Rouzier R, Marbury T, Nguyen T, Ke J, Huang M, Praestgaard J, Serra D, Evans TG. Safety, pharmacokinetics, and antiviral activity of the cyclophilin inhibitor NIM811 alone or in combination with pegylated interferon in HCV-infected patients receiving 14 days of therapy. Antiviral Res. 2011 Mar;89(3):238-45. doi: 10.1016/j.antiviral.2011.01.003. Epub 2011 Jan 19.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6083', 'label': 'Results for CNIM811B2202 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'This is a study designed to identify a dose of NIM811 that has a good safety profile, is well tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral load reduction compared to SOC alone. This information will be used to support doses selected for future studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nPatients eligible for inclusion in this study have to fulfill all of the following criteria:\n\n* chronic hepatitis C genotype-1\n* HCV-RNA should be ≥ 4 x 105 IU/mL at screening\n* Recipient of prior long acting interferon and ribavirin treatment for at least 12 weeks, with documented negative serum HCV RNA on treatment, who subsequently becomes serum HCV RNA positive after stopping treatment ("relapser"). Patients must have been off all treatment for at least 3 months prior to start of study (Visit\n\nExclusion criteria:\n\n* Use of any HCV treatment ≤ 3months prior to study start\n* Prior receipt of any investigational anti-HCV therapy which is not IFN or RBV\n* Women of child-bearing potential unless they are post-menopausal or use predefined acceptable methods of contraception\n* Pregnant or breastfeeding women\n* Evidence of cirrhosis, hepatic decompensation, other than HCV liver disease, HBV or HIV infection\n* Specified abnormalities in lab values of amongst others hemoglobin, WBC, ANC, platelets\n* History of treatment for depression\n* Steroid/immunosuppression drug use 3 months prior to study start Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00983060', 'briefTitle': 'Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Adaptive-design, Dose-finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With the Standard of Care (SOC) in Relapsed Patients Infected With HCV Genotype-1', 'orgStudyIdInfo': {'id': 'CNIM811B2202'}, 'secondaryIdInfos': [{'id': 'EUDRACT number: 2009-009995-11'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NIM811', 'interventionNames': ['Drug: NIM811']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo BID + SOC']}], 'interventions': [{'name': 'NIM811', 'type': 'DRUG', 'description': 'BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)', 'armGroupLabels': ['NIM811']}, {'name': 'Placebo BID + SOC', 'type': 'DRUG', 'description': 'Placebo BID + SOC (PEG IFN and RBV)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92105', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research and Education Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34243', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'University Hepatitis Center', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "West Wind'r Research & Development LLC", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Alamo Medical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Clayton', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Novartis Investigative Site'}, {'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'city': 'Wentworthville', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Novartis Investigative Site'}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '00909', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Fundacion de Investigacion de Diego', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Taipei', 'state': 'ROC', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}