Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-29 @ 6:57 AM
Study NCT ID:
NCT03718403
Status:
RECRUITING
Last Update Posted:
2022-07-22
First Post:
2017-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Theophylline in Pseudohypoparathyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011547', 'term': 'Pseudohypoparathyroidism'}, {'id': 'C548076', 'term': 'Pseudohypoparathyroidism Type 1C'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008664', 'term': 'Metal Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013806', 'term': 'Theophylline'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open label intervention study, off label use of theophylline'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2032-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-20', 'studyFirstSubmitDate': '2017-09-08', 'studyFirstSubmitQcDate': '2018-10-22', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Theophylline on Bone Age in PHP', 'timeFrame': '52 weeks', 'description': 'Change in Bone age ( in years and months) before and after theophylline administration for 52 weeks'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PHP'], 'conditions': ['PHP Ia', 'PHP IB', 'Php1C']}, 'descriptionModule': {'briefSummary': 'The study evaluates the effect of theophylline in 100 subjects with Pseudohypoparathyroidism.', 'detailedDescription': 'It is an open label intervention study for the off-label use of theophylline in psuedohypoparathyroidism (PHP).Theophylline is a is non-specific phosphodiesterase inhibitor which increases the levels of secondary messenger,cAMP. PHP patients have end organ resistance to hormones involving cAMP signaling. Thus, theophylline has a potential to abrogate hormone resistance. Also, it may have a role in bone maturation, neurocognition and metabolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with known diagnosis of PHP1A and PHP1B\n* Age \\>5 years\n\nExclusion Criteria:\n\n* • Significant kidney disease, i.e. any CKD stage\n\n * Hypercalciuria\n * Kidney stones\n * Severe Heart disease\n * Uncontrolled seizure disorder\n * Peptic ulcer\n * Liver dysfunction\n * Bleeding disorder\n * Allergy to theophylline preparation\n * Muscle disorder\n * Infection\n * Any neurologic disease\n * Chronic drugs interacting with theophylline'}, 'identificationModule': {'nctId': 'NCT03718403', 'briefTitle': 'Effect of Theophylline in Pseudohypoparathyroidism', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Effect of Theophylline in Pseudohypoparathyroidism', 'orgStudyIdInfo': {'id': 'Theophylline in PHP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm open labeled intervention study', 'description': 'Subjects with PHP will be given theophylline to decrease the end organ resistance by increasing levels of cAMP, a second messenger. Theophylline will be dosed twice a day for a period of 52 weeks.', 'interventionNames': ['Drug: Theophylline']}], 'interventions': [{'name': 'Theophylline', 'type': 'DRUG', 'description': 'Theophylline will be given to maintain a peak level between 10-15 mcg/mL', 'armGroupLabels': ['Single arm open labeled intervention study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amita Sharma', 'role': 'CONTACT', 'email': 'asharma5@mgh.harvard.edu', 'phone': '617-726-2908'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'AMITA SHARMA, MD', 'role': 'CONTACT', 'email': 'asharma5@mgh.harvard.edu', 'phone': '6177262908'}], 'overallOfficials': [{'name': 'AMITA SHARMA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director, Division of Pediatric Nephrology', 'investigatorFullName': 'Amita Sharma', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}