Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-25 @ 9:02 PM
Study NCT ID:
NCT05584956
Status:
UNKNOWN
Last Update Posted:
2022-10-18
First Post:
2022-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Possible Efficacy and Safety of L- Carnitine and Sildenafil in Children Having Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-07-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-14', 'studyFirstSubmitDate': '2022-10-13', 'studyFirstSubmitQcDate': '2022-10-14', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiopulmonary functions', 'timeFrame': '3 months', 'description': 'change in the studied cardiopulmonary functions at the baseline and 3 months after intervention'}], 'secondaryOutcomes': [{'measure': 'Biochemical parameters', 'timeFrame': '3 months', 'description': 'Changes in Vascular Endothelial Growth Factor level (VEGF) at baseline and 3 months after the intervention'}, {'measure': 'Biochemical parameters', 'timeFrame': '3 months', 'description': 'Changes in Nitric oxide level (NO) at the baseline and 3 months after the intervention'}, {'measure': 'Biochemical parameters', 'timeFrame': '3 months', 'description': 'Changes in ferritin serum level at the baseline and 3 months after the intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the possible efficacy and safety of L\\_Carnitine and Sildenafil on patient with Beta thalassemia complicated with increased Tricuspid Regurgitant Jet Velocity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with Beta thalassemia major who have increased TRJV more than 2.5m/s.\n* Children age from 6-18 years\n\nExclusion Criteria:\n\n* Others hemolytic anemia\n\n * Young age before 6 years of age\n * Allergy to Sildenafil or L-carnitine\n * Patient with documented causes of pulmonary hypertension rather than caused by Beta thalassemia.\n * Hepatic dysfunction: serum Alanine Aminotransferase (ALT) 3X.\n * Renal dysfunction: Creatinine level greater than or equal to 1.2 mg/dl.'}, 'identificationModule': {'nctId': 'NCT05584956', 'briefTitle': 'Clinical Study to Evaluate the Possible Efficacy and Safety of L- Carnitine and Sildenafil in Children Having Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Clinical Study to Evaluate the Possible Efficacy and Safety of L- Carnitine and Sildenafil in Children Having Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity', 'orgStudyIdInfo': {'id': 'Beta thalassemia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'n=22): Patients will receive traditional treatment and L- carnitine 50mg/kg/day orally (maximum dose 3g per day)', 'interventionNames': ['Drug: L_carnitine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'n=22): Patients will receive traditional treatment and Sildenafil 0.25mg/kg/dose every 6 h orally (maximum dose 60 mg per day)', 'interventionNames': ['Drug: Sildenafil']}], 'interventions': [{'name': 'L_carnitine', 'type': 'DRUG', 'description': 'l-carnitine stabilizes red blood cell membranes and thus improves the anemic state\\[', 'armGroupLabels': ['Group 1']}, {'name': 'Sildenafil', 'type': 'DRUG', 'description': 'selective and potent inhibitor of cGMP-specific phosphodiesterase 5 (PDE5), which promotes smooth muscle relaxation in lung vasculature, has been used successfully in the treatment of primary and secondary PH.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31511', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Ramadan El_shanshory, Professor', 'role': 'CONTACT'}], 'facility': 'Tanta University Hospital', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Mostafa Zaki Zedan, Bsc of pharmaceutical science', 'role': 'CONTACT', 'email': 'mostaf150776@pharm.tanta.edu.eg', 'phone': '+0201554676330'}], 'overallOfficials': [{'name': 'Sahar Kamal Hegazy, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical pharmacist', 'investigatorFullName': 'Mostafa Zaki Zedan', 'investigatorAffiliation': 'Tanta University'}}}}