Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT00227435
Status:
COMPLETED
Last Update Posted:
2016-04-27
First Post:
2005-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose Escalation Study to Evaluate the Safety and Antiviral Activity of Val-mCyd in Adults With Chronic Hepatitis C
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-25', 'studyFirstSubmitDate': '2005-09-26', 'studyFirstSubmitQcDate': '2005-09-26', 'lastUpdatePostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This study was conducted to determine the safety, tolerance, pharmacokinetics and antiviral activity of val-mCyd at doses ranging from 50 mg to 800 mg per day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented clinical history of chronic hepatitis C and compensated liver disease\n* No antiviral treatment for hepatitis C in the 6 months prior to the Screening visit\n\nOther protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Patient is pregnant or breastfeeding\n* Patient is co-infected with HBV or HIV\n\nOther protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00227435', 'briefTitle': 'Dose Escalation Study to Evaluate the Safety and Antiviral Activity of Val-mCyd in Adults With Chronic Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase I/II Double-Blind, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Val-mCyd (NM283) in Adults With Chronic Hepatitis C', 'orgStudyIdInfo': {'id': 'NV-08A-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'val-mCyd', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}