Is dit een Europese test voor T4 plus T3 medicatie ?
Geplaatst: za 29 maart 2014, 15:23Mellie heeft - onder Waardevolle informatie - deze trial geplaatst:
Maar is dit een Europese test met hetzelfde doel als de Amerikaanse testonderzoek of geheel iets anders ?
Full title of the trial
Substitutive therapy of hypothyroid patients with L-thyroxine (T4) plus T3 sulfate (T3S).
A Phase II, open-label, single centre, parallel group study on therapeutic efficacy and tolerability
E.2 Objective of the trial
E.2.1 Main objective of the trial
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.
E.2.2 Secondary objectives of the trial
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.
E.3 Principal 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 (<5) (absence of endogenous thyroid hormones production); acceptable metabolic control (FT4, FT3 and TSH values inside the normal ranges); patient’s co-operative attitude and able to understand and adhere to study protocol procedures and timelines.
E.5.1 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
Zie uitgebreide info (ook uit te printen downloaden)
https://www.clinicaltrialsregister.eu/c ... 8663-42/IT
Thyromax - vertraagde afgifte T3
In Amerika wordt op dit moment een klinische test opgestart in het Georgetown University Hospital , met een nieuw medicijn voor hypothyreoïdie: Thyromax. Het medicijn bevat het al goedgekeurde liothyronine natrium, beter bekend als T3. Het nieuwe aan Thyromax is dat het een hormoonpreparaat is met vertraagde afgifte van de T3
viewtopic.php?f=21&t=2393
Maar is dit een Europese test met hetzelfde doel als de Amerikaanse testonderzoek of geheel iets anders ?
Full title of the trial
Substitutive therapy of hypothyroid patients with L-thyroxine (T4) plus T3 sulfate (T3S).
A Phase II, open-label, single centre, parallel group study on therapeutic efficacy and tolerability
E.2 Objective of the trial
E.2.1 Main objective of the trial
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.
E.2.2 Secondary objectives of the trial
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.
E.3 Principal 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 (<5) (absence of endogenous thyroid hormones production); acceptable metabolic control (FT4, FT3 and TSH values inside the normal ranges); patient’s co-operative attitude and able to understand and adhere to study protocol procedures and timelines.
E.5.1 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
Zie uitgebreide info (ook uit te printen downloaden)
https://www.clinicaltrialsregister.eu/c ... 8663-42/IT