Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT04883905
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2021-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ELEVATE, a Registry of Patients With Acute Hepatic Porphyria (AHP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046349', 'term': 'Coproporphyria, Hereditary'}], 'ancestors': [{'id': 'D017094', 'term': 'Porphyrias, Hepatic'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D011164', 'term': 'Porphyrias'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2021-05-07', 'studyFirstSubmitQcDate': '2021-05-07', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Selected Events of Interest in AHP Patients', 'timeFrame': 'Up to 6 years', 'description': 'Selected events of interest are defined as hepatic events (including hepatic neoplasia), renal events, thromboembolic events, and pancreatitis.'}], 'secondaryOutcomes': [{'measure': 'Annualized Rate of Porphyria Attacks', 'timeFrame': 'Up to 6 years', 'description': "Porphyria attacks are defined as meeting all of the following criteria: an acute episode of neurovisceral pain in the abdomen, back, chest, extremities and/or limbs, no other medically determined cause, and requires treatment with intravenous (IV) dextrose or hemin, carbohydrates, or analgesics, or other medications such as antiemetics at a dose or frequency beyond the participant's usual daily porphyria management."}, {'measure': '12-Item Short Form Health Survey Version 2 (SF-12 V2) (Standard Version)', 'timeFrame': 'Up to 6 years', 'description': 'S-12 V2 is a 12-question measure capturing global quality of life and overall health status and evaluates the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Givosiran', 'AHP', 'Acute hepatic porphyria'], 'conditions': ['Acute Hepatic Porphyria']}, 'descriptionModule': {'briefSummary': 'This global patient registry is being conducted to characterize the natural history and real-world clinical management of patients with AHP, and to further characterize the real-world safety and effectiveness of givosiran and other approved AHP therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with all types of AHP, including patients with hepatic and/or renal impairment, adolescents, elderly patient, and pregnant or lactating women.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documented diagnosis of AHP, per physician's determination\n\nExclusion Criteria:\n\n* Currently enrolled in a clinical trial for any investigational agent"}, 'identificationModule': {'nctId': 'NCT04883905', 'acronym': 'ELEVATE', 'briefTitle': 'ELEVATE, a Registry of Patients With Acute Hepatic Porphyria (AHP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alnylam Pharmaceuticals'}, 'officialTitle': 'ELEVATE, a Global Observational Longitudinal Prospective Registry of Patients With Acute Hepatic Porphyria (AHP)', 'orgStudyIdInfo': {'id': 'ALN-AS1-006'}, 'secondaryIdInfos': [{'id': 'EUPAS43201', 'type': 'REGISTRY', 'domain': 'EU PAS REGISTER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with AHP', 'description': 'Patients with a diagnosis of AHP will be eligible for the study and will be managed and treated per routine clinical practice.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '90074', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Chemnitz', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'city': 'Würzburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Modena', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Cardiff', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Alnylam Clinical Trial Information Line', 'role': 'CONTACT', 'email': 'clinicaltrials@alnylam.com', 'phone': '1-877-ALNYLAM'}, {'name': 'Alnylam Clinical Trial Information Line', 'role': 'CONTACT', 'email': 'clinicaltrials@alnylam.com', 'phone': '1-877-256-9526'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alnylam Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alnylam Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}