Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT00120835
Status:
COMPLETED
Last Update Posted:
2010-06-10
First Post:
2005-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506207', 'term': 'valopicitabine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'statusVerifiedDate': '2010-06', 'lastUpdateSubmitDate': '2010-06-09', 'studyFirstSubmitDate': '2005-07-11', 'studyFirstSubmitQcDate': '2005-07-18', 'lastUpdatePostDateStruct': {'date': '2010-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Genotype-1', 'Treatment-Naive'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This study is being conducted in treatment-naive patients (no previous hepatitis C treatment) to evaluate the safety of valopicitabine (NM283) alone and together with pegylated interferon, a drug approved by the Food and Drug Administration for the treatment of hepatitis C infection. This study is also evaluating the ability of valopicitabine to decrease the amount of hepatitis C virus in the body. The results for patients taking valopicitabine alone will be compared with the results for patients taking valopicitabine together with pegylated interferon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented clinical history compatible with genotype-1, chronic hepatitis C infection\n* Treatment-naive (patient has received no previous therapy for hepatitis C viral infection)\n\nOther protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Patient is pregnant\n* Patient is co-infected with hepatitis B or HIV\n\nOther protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00120835', 'briefTitle': 'Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and the Antiviral Activity of NM283 When Administered Alone and in Combination With Pegylated Interferon Alfa 2b to Treatment-Naive Adults With Genotype-1 Chronic Hepatitis C', 'orgStudyIdInfo': {'id': 'NV-08A-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'valopicitabine', 'type': 'DRUG'}, {'name': 'pegylated interferon', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Santurce', 'country': 'Puerto Rico', 'geoPoint': {'lat': 18.19523, 'lon': -67.14018}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}}}}