Thyroidectomized patients without endogenous hormonal production (Tg<5) in stable substitutive therapy with T4 MedDRA version: 9.1 Level: LLT Classification code 10021117
Conditions
Interventions
Product Name: T3 sulfate
Pharmaceutical Form: Tablet
Other descriptive name: T3-sulfate monosodium salt
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
Produc
Sponsors
BRACCO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be enrolled if they meet all the following inclusion criteria: written informed consent obtained; outpatients of either sex, aged between 18 and 70 years; hypothyroid for any raison, in T4 substitutive therapy (daily dose: 100/125/150 mcg); undetectable Tg (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will not be enrolled if they meet any of the following exclusion criteria: history or current evidence of cardiovascular diseases, e.g. congestive heart failure NYHA class > 1, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias; history or current evidence of significant liver (i.e. AST/ALT higher than twice the upper limit of normal range) or renal (i.e. creatinine > 2 mg/dl) insufficiency, of metabolic or endocrine diseases (e.g. uncontrolled diabetes mellitus), or of any other underlying medical condition that might interfere with the study evaluation parameters; assumption of drugs affecting thyroid hormone GI absorption or metabolism; any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations; immunocompromised patients; malignant disease or any other disease with life expectancy less than 2 years; history of alcoholism, drug abuse, psychological or other psychiatric diseases that could invalidate informed consent or limit the subject compliance with protocol requirements; artificial or parenteral feeding; allergy, sensitivity or intolerance to study drugs and/or any of study drug formulation ingredients; pregnant or breastfeeding females, or those females not practicing adequate contraceptive measures; patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; patients who received any investigational drug within the last 3 months; patients who have been previously enrolled in this study; employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to check the possibility of maintain the metabolic control, evaluated on the basis of the TT3, FT3, FT4 and TSH circulating levels, obtained in hypothyroid patients with the T4 administration, partially substituting the T4 dose with T3S.;Secondary Objective: The secondary objectives of the study are to check the safety of T3S prolonged administration; to find the optimal T4/T3S substitutive ratio; to compare the judgment of the patients on T4 vs T4+T3S therapy.;Primary end point(s): The primary efficacy variable will be the responder variable: patients will be considered as responders if metabolic control is maintained (independently of the T3S previous dose administered) within the visit V3c | — |
Countries
Italy
Outcome results
None listed