Clinical TrialID 7979
LT4/LT3 Combination Therapy Versus LT4 Monotherapy in Patients With Autoimmune Hypothyroidism.
NCT05682482
Autoimmune Hypothyroidism
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7979
- Evidence Id
- 7979
- Core Evidence Id
- 7979
- Source Clinical Trial Id
- 7974
- Herb2 Clinical Trial Id
- HBCT007974
- Nct Id
- NCT05682482
- Title
- LT4/LT3 Combination Therapy Versus LT4 Monotherapy in Patients With Autoimmune Hypothyroidism.
- Status
- Recruiting
- Phase
- Phase 3
- Study Result
- No
- Study Condition
- Autoimmune Hypothyroidism
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: LT3 (liothyronine)|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Triple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 600
- Outcome Measure
- Mean change from baseline to 52 weeks in the ThyPRO tiredness subscale scores., Thyroid specific Patient Reported Outcome (ThyPRO) questionnaire, with the tiredness subscale ranging from 0-100 (higher scores indicate a worse outcome). ThyPRO Questionnaires will be performed at every RCT visit., 52 weeks|Effect sizes in genetic subgroups, In case it is confirmed that LT4/LT3 combination therapy reduces tiredness compared to LT4 treatment alone, we will simultaneously investigate whether effect sizes are higher in patients with genetic variation in the type 2 deiodinase (DIO2-rs225014) and effect sizes are higher in patients with genetic variation in the monocarboxylate transporter 10 (MCT10-rs17606253), ensuring control of the study-wise type 1 error (of 5% two-sided) across these three main questions., 52 weeks
- Sponsor Collaborator
- M. Medici|ZonMw: The Netherlands Organisation for Health Research and Development|ACE Pharmaceuticals BV
- Funded By
- OTHER
- Location
- Amsterdam UMC - Location AMC, Amsterdam, Netherlands|Rijnstate, Arnhem, Netherlands|Van Weel-Bethesda Hospital, Dirksland, Netherlands|Albert Schweitzer Hospital, Dordrecht, Netherlands|Admiraal de Ruyter Hospital, Goes, Netherlands|University Medical Center Groningen, Groningen, Netherlands|Leiden University Medical Center, Leiden, Netherlands|Maastricht University Medical Center, Maastricht, Netherlands|Radboudumc, Nijmegen, Netherlands|Erasmus Medical Center, Rotterdam, Netherlands|Maasstad Hospital, Rotterdam, Netherlands|Franciscus Gasthuis & Vlietland, Schiedam, Netherlands|Zuyderland, Sittard, Netherlands|University Medical Center Utrecht, Utrecht, Netherlands|Maxima Medical Center, Veldhoven, Netherlands
- Other Id
- NL74281.078.21
- Start Date
- 2022-10-07
- Primary Completion Date
- 2028-01
- Completion Date
- 2028-01
- First Posted
- 2023-01-12
- Results First Posted
- Last Update Posted
- 2024-08-27
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05682482
- Title Cn
- Title En
- LT4/LT3 Combination Therapy Versus LT4 Monotherapy in Patients With Autoimmune Hypothyroidism.
- Bilingual Status
- semi_complete