Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-03 @ 10:02 PM
Study NCT ID:
NCT00829192
Status:
UNKNOWN
Last Update Posted:
2010-12-06
First Post:
2009-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II AK Study in Organ Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C534526', 'term': 'afamelanotide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-03', 'studyFirstSubmitDate': '2009-01-23', 'studyFirstSubmitQcDate': '2009-01-23', 'lastUpdatePostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the effect of afamelanotide (CUV1647) administered from slow release subcutaneous implants on the number of actinic keratoses (AKs) on the head, forearms and back of hands', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC)', 'timeFrame': '24 months'}, {'measure': 'To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group', 'timeFrame': '24 months'}, {'measure': 'To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647)', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Actinic keratoses (AK)', 'Squamous cell carcinomas (SCC)', 'CUV1647', 'Afamelanotide', 'Clinuvel', 'Photoprotection', 'Organ transplant'], 'conditions': ['Actinic Keratoses', 'Carcinoma, Squamous Cell', 'Organ Transplant Recipients']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period.\n\nThe number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Organ transplant recipients with stable transplant function and who received their transplant at least 2 years prior to study entry\n* Organ transplant patients who have had at least one biopsy-positive SCC\n* Aged 18 - 75 years\n* Written informed consent to the performance of all study-specific procedures\n\nExclusion Criteria:\n\n* Allergy to afamelanotide (CUV1647) or the polymer contained in the implant\n* History of melanoma\n* Current pigmentary disorders such as melasma\n* Diagnosed with HIV/AIDS, or hepatitis B or C\n* Current history of drug or alcohol abuse (in the last 12 months)\n* Clinically significant organ dysfunction, history of medical disorders or other factors, which in the opinion of the investigator will interfere with the interpretation of study outcome measures\n* Major medical or psychiatric illness\n* Pregnancy as confirmed by positive serum beta-HCG pregnancy test prior to baseline or lactating mothers\n* Females of child bearing potential not using adequate contraceptive measures\n* Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit\n* Use of regular medications or any other factors that may affect skin pigmentation\n\nDiscontinuation Criteria:\n\n* Initiation of treatment with systemic retinoids\n* Change of class of systemic immunosuppressant treatment'}, 'identificationModule': {'nctId': 'NCT00829192', 'briefTitle': 'Phase II AK Study in Organ Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clinuvel Pharmaceuticals Limited'}, 'officialTitle': 'A Multicentre, Randomised, Double-Blind, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of Afamelanotide (CUV1647) for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients.', 'orgStudyIdInfo': {'id': 'CUV011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months', 'interventionNames': ['Drug: Afamelanotide (CUV1647)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo implant administered subcutaneously every 60 days for 24 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Afamelanotide (CUV1647)', 'type': 'DRUG', 'description': '16 mg subcutaneous implant administered every 60 days', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo subcutaneous implant administered every 60 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4102', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'The Princess Alexandra Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '5011', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'The Queen Elizabeth Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Royal Melbourne Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hospital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'Gent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Besançon', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Univeritätsklinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'Kiel University Hospital', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Bergamo', 'country': 'Italy', 'facility': 'Ospedali Riuniti di Bergamo', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'University of Padua', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Günther Hofbauer, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsspital Zürich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinuvel Pharmaceuticals Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr Dennis Wright', 'oldOrganization': 'Clinuvel Pharmaceuticals'}}}}