T3-4-Hypo trial Nederland (Dr. Marco Medici - Radboud UMC)

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ineke
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Lid geworden op: 08 nov 2014, 17:53

T3-4-Hypo trial Nederland (Dr. Marco Medici - Radboud UMC)

Bericht door ineke » 03 nov 2019, 17:13

T3-4-Hypo trial - Dr. Marco Medici, Radboud UMC




LT4/LT3 Combination therapy for hypothyroidism (T3-4-Hypo trial)



Samenvatting van de aanvraag

1. Problem definition/rationale:
Hypothyroidism is among the most common diseases in the general population, for which levothyroxine (LT4) is the standard treatment.
A substantial group of patients (~10%) do not feel well on LT4 monotherapy and have persisting debilitating complaints, leading to a poor quality of life.
These patients could benefit from the addition of LT3, but results have been contradictory, largely due to a wrong study design.


2. Objectives:
To investigate the efficacy of LT4/LT3 combination therapy in hypothyroidism, and what factors (genetic, biochemical, or metabolic profiles) predict its efficacy.


3. Study design:

Multicenter double-blind randomized placebo-controlled trial.


4. Patient population:
Patients with autoimmune hypothyroidism on LT4 monotherapy with persisting complaints.


5. Investigational product & comparator:

LT4/LT3 vs LT4/placebo. Treatment duration: 52 weeks.


6. Outcome variables & assessment:
The primary study endpoints are the Hypothyroid Symptoms and the Tiredness scores of the thyroid-specific ThyPRO questionnaire.


7. Analysis:
Primary analyses include the mean change from baseline to 52 weeks in the ThyPRO scores.


8. Sample size calculation:
With 600 patients we will have 80% power to detect changes of 3.7 and 5.0 points on the Hypothyroid Symptoms and on the Tiredness scales, respectively.


9. Economic evaluation:
Cost-utility analysis from a societal perspective.


Projectgegevens
Projectnummer - 848043003
Status - Lopend
Looptijd - 2019/2024
Onderdeel van programma - Goed Gebruik Geneesmiddelen


Projectleider en penvoerder:
Dr. M. Medici Radboud Umc


Bron:
https://www.zonmw.nl/nl/over-zonmw/inno ... verslagen/



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