Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-04 @ 11:08 PM
Study NCT ID:
NCT07133295
Status:
COMPLETED
Last Update Posted:
2025-08-21
First Post:
2025-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Efficacy and Safety of Once-Weekly Levothyroxine Regimen in Hypothyroid Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007037', 'term': 'Hypothyroidism'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-05-16', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be the maintenance of euthyroidism,defined as normal thyroid function', 'timeFrame': 'From baseline (study enrollment) until 36 months after enrollment. first year :assessments will be conducted 2 months after each dose adjustment in subsequent years assessment conducted quarterly up to end of the study', 'description': 'Normal thyroid function, assessed via:\n\nTSH: Normal range \\[specify, e.g., 0.4-4.0 µIU/mL\\]\n\nFree T4: Normal range \\[specify, e.g., 0.8-1.8 ng/dL\\]'}], 'secondaryOutcomes': [{'measure': '. Secondary outcomes will include:-1- the incidence of adverse effects(clinical parameters)', 'timeFrame': '1-Baseline (Day 1) until 24 months 2-Week 8 (2 months post-initial dose adjustment) 3-Every 12 weeks (±7 days) thereafter until study completion (up to 24 months)', 'description': '1-Incidence of Adverse Effects:\\* Clinical parameters:\n\n1. Heart rate (beats per minute)\n2. Blood pressure (mmHg)'}, {'measure': 'secondary outcome 2-Incidence of Adverse Effects - Laboratory Parameters (Complete Blood Count)', 'timeFrame': 'From Baseline (Day 1) until study completion (up to 24 months), assessed at Week 8 (2 months post-initial dose adjustment) and every 12 weeks (±7 days) thereafter.', 'description': 'Incidence of clinically significant abnormalities in Complete Blood Count Unit of Measure: (e.g., cell counts in cells/µL, hemoglobin in g/dL, hematocrit in %)'}, {'measure': 'secondary outcome. 3- Incidence of Adverse Effects - Laboratory Parameters (Liver Function Tests)', 'timeFrame': 'From Baseline (Day 1) until study completion (up to 24 months), assessed at Week 8 (2 months post-initial dose adjustment) and every 12 weeks (±7 days) thereafter.', 'description': 'Incidence of clinical abnormalities Liver Function Tests(e.g., ALT, AST) U/L\n\nUnit of Measure: U/L'}, {'measure': '4-Incidence of Adverse Effects - Laboratory Parameters (Kidney Function Tests)', 'timeFrame': 'From Baseline (Day 1) until study completion (up to 24 months), assessed at Week 8 (2 months post-initial dose adjustment) and every 12 weeks (±7 days) thereafter.', 'description': 'Incidence of clinical abnormalities in Kidney Function Tests (e.g., serum creatinine)\n\nUnit of Measure: mg/dL'}, {'measure': 'secondary outcome include :-2-Patient Adherence Rates', 'timeFrame': '1-from baseline(day 1) until 36 months 2-Monthly from Baseline to Week 52 3-- 12 weeks from Week 52 to study completion', 'description': '2-Patient Adherence Rates :Measured via self-report, pill counts, or pharmacy refill records. Criteria for adherence (e.g., ≥80% of doses taken).'}, {'measure': 'secondary outcome include:-3. Quality of Life (QoL) Assessments using ThyPRO', 'timeFrame': '1-From Baseline(day 1) until 36 months after enrollment assessed at Baseline, Week 8, Week 24, Week 52, and every 24 weeks thereafter.', 'description': 'Thyroid-specific QoL measured using validated questionnaires:\n\nThyPRO (Thyroid Patient-Reported Outcome)\n\nUnit of Measure:\n\nThyPRO: Scale scores (0-100)'}, {'measure': 'Quality of Life (QoL) Assessments - SF-36', 'timeFrame': 'From Baseline (day 1)until 36 months Aassessed at Baseline, Week 8, Week 24, Week 52, and every 24 weeks thereafter.', 'description': 'chang in general quality of life using SF-36 (Short Form Health Survey) questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypothyroidism']}, 'descriptionModule': {'briefSummary': 'Hypothyroidism is a prevalent endocrine disorder characterized by insufficient production of thyroid hormones. Traditional treatment involves daily administration of levothyroxine (L-T4), which can be challenging for some patients due to adherence issues. Recent studies have explored the efficacy of once-weekly L-T4 regimens, suggesting that they may provide a viable alternative for patients struggling with daily dosing The safety profile of once-weekly L-T4 has also been a focus of recent research. Evidence indicates that this regimen is associated with minimal side effects and is well-tolerated by patients. A comparative study found that once-weekly L-T4 did not result in significant adverse effects compared to daily dosing, reinforcing its potential as a safe treatment option', 'detailedDescription': 'Hypothyroidism is a prevalent endocrine disorder characterized by insufficient production of thyroid hormones. Traditional treatment involves daily administration of levothyroxine (L-T4), which can be challenging for some patients due to adherence issues. Recent studies have explored the efficacy of once-weekly L-T4 regimens, suggesting that they may provide a viable alternative for patients struggling with daily dosing. A study published in 2023 demonstrated that once-weekly L-T4 is effective in maintaining euthyroidism in patients with treatment-refractory hypothyroidism.\n\nThe safety profile of once-weekly L-T4 has also been a focus of recent research. Evidence indicates that this regimen is associated with minimal side effects and is well-tolerated by patients.\n\nAdherence to treatment is crucial for the management of hypothyroidism, and once-weekly regimens may enhance patient compliance. Studies have shown that patients are more likely to adhere to a once-weekly regimen compared to daily dosing, which can lead to improved clinical outcomes. This is particularly relevant for patients with non-adherence issues, as highlighted in recent literature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This a prospective randomized conducted over three years will be including hypothyroid patients attending outpatient clinic, Sohag faculty of medicine, Sohag university, Egypt.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All included hypothyrodism patients will be euthyroid, and stable on the same L-T4 dose before the start of study.\n\nExclusion Criteria:\n\n-1- patients with thyroid cancer patients requiring suppressive therapy 2-patients with central hypothyroidism 3- pregnancy, coronary heart disease, arrythmia, chronic heart failure 4-patients with liver cirrhosis, renal failure, acute medical, or surgical illness at the time of evaluation to avoid acute and chronic non-thyroidal illness syndromes.\n\n4- Patients taking any medications known to interfere with levothyroxine absorption or metabolism (calcium and iron supplements, antiepileptic agents, antacids, proton pump inhibitors, and H2blockers)'}, 'identificationModule': {'nctId': 'NCT07133295', 'briefTitle': 'Long-Term Efficacy and Safety of Once-Weekly Levothyroxine Regimen in Hypothyroid Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Long-Term Efficacy and Safety of Once-Weekly Levothyroxine Regimen in Hypothyroid Patients: A Three-Year Follow-Up Study', 'orgStudyIdInfo': {'id': 'Soh-Med-25-4--7PD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 patients who will continue to take L-T4 on standard daily basis.'}, {'label': 'Group 2 patients who will switch to once weekly dosing'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'sohag faculty of medicine, Sohag', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'sara Kasem Abdelal, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'sohag university .faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of internal medicine department', 'investigatorFullName': 'Hany Ahmed Mohamed', 'investigatorAffiliation': 'Sohag University'}}}}