Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-03-03 @ 5:03 PM
Study NCT ID:
NCT01884402
Status:
COMPLETED
Last Update Posted:
2014-09-04
First Post:
2013-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational,Prospective Study to Develop and Validate a Prognostic Tool to Optimize Therapy in Patients With HCV G1/4
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': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 770}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-03', 'studyFirstSubmitDate': '2013-06-18', 'studyFirstSubmitQcDate': '2013-06-20', 'lastUpdatePostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained Viral Response (RVS)', 'timeFrame': '1 ½ years (72 weeks)', 'description': 'Measurement of HCV RNA negativization 24 weeks after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\n• Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment.', 'detailedDescription': 'This Tool:\n\n1. Predicting the overall impact of prognostic factors (including the new factor of genetic polymorphism of the IL28B) on Sustained Viral Response (SVR).\n2. Identify those patients most likely to respond.\n3. Therapy and therefore optimize resources\n\nThe validation tool will check into clinical practice its predictive power (it will consider its ability to calibrate and discriminate) and make correct inferences and interpretations of the scores obtained when applying.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic hepatitis C genotype 1 and 4 mono-or co-infected with HIV who meet the selection criteria described.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with \\> 18 years old.\n* Patients diagnosed with chronic hepatitis C in the presence of HCV RNA in plasma that meet criteria for initiating antiviral therapy in routine clinical practice conditions.\n* Patients Genotype 1 and 4.\n* Patients with the results of all the factors evaluable at the time of inclusion.\n* Patients who have accepted their participation in the study through informed consent.\n\nExclusion Criteria:\n\n* Patients previously treated with interferon (IFN) and ribavirin (RBV).\n* Patients with genotype 2, 3, 5 and 6.\n* Patients with co-infection with hepatitis B.\n* Patients with other liver diseases.\n* Patients with any contraindications to the drugs used in the treatment of hepatitis C.'}, 'identificationModule': {'nctId': 'NCT01884402', 'acronym': 'OPTIM', 'briefTitle': 'Observational,Prospective Study to Develop and Validate a Prognostic Tool to Optimize Therapy in Patients With HCV G1/4', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla'}, 'officialTitle': 'Observational,Post-authorization Prospective Study to Develop and Validate a Prognostic Tool for Optimizing Therapy in Patients With Hepatitis C Virus (HCV) Genotype 1 and 4.', 'orgStudyIdInfo': {'id': 'FPS-PEG-2010-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pegasys, injection subcutaneous', 'description': 'HCV patients monoinfected or coinfected genotype 1/4 treated with Peginterferon alfa-2a and Ribavirin', 'interventionNames': ['Drug: Peginterferon alfa-2a', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Peginterferon alfa-2a', 'type': 'DRUG', 'otherNames': ['Pegasys'], 'description': 'Treatment as usual clinical practice', 'armGroupLabels': ['Pegasys, injection subcutaneous']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Copegus'], 'description': 'Treatment as usual clinical practice', 'armGroupLabels': ['Pegasys, injection subcutaneous']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seville', 'state': 'Sevilla', 'country': 'Spain', 'facility': 'Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Manuel Romero-Gómez, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Valme & ciberEHD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}