Adding genistein to Ivacaftor treatment leads to higher levels of restoration of the CFTR protein channel activity in patients with a mutation associated with residual CFTR function.
ID
Bron
Verkorte titel
Aandoening
Cystic Fibrosis, Taaislijmziekte, CF
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study parameter is pulmonary function (%FEV1) measured before and after the use
of genistein and before and after the use of placebo.
Doel van het onderzoek
Adding genistein to Ivacaftor treatment leads to higher levels of restoration of the CFTR protein channel activity in patients with a mutation associated with residual CFTR function.
Onderzoeksopzet
- Before placebo
- After using placebo for 8 weeks
- Before genistein
- After using genistein for 8 weeks
Onderzoeksproduct en/of interventie
Genistein or Placebo
Publiek
Huispostnummer KH 01.419.0
Postbus 85090
G. Berkers
Utrecht 3508 AB
The Netherlands
+ 31 (0)88-75 537 41
g.berkers-3@umcutrecht.nl
Wetenschappelijk
Huispostnummer KH 01.419.0
Postbus 85090
G. Berkers
Utrecht 3508 AB
The Netherlands
+ 31 (0)88-75 537 41
g.berkers-3@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
· CFTR genotype: at least one S1251N mutation;
· Already had a rectal biopsy to produce an organoid;
· Use of Ivacaftor;
· Male and female patients, aged 6 years or older on the date of informed consent;
· Signed informed consent form (IC).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
· Use of genistein or curcumin at start or within four weeks prior to start of the study;
· Severe acute exacerbation or pulmonary infection during last four weeks (needing
intravenous treatment and/or systemic corticosteroids);
· (History of) hypothyroidism;
· Women who are trying to become pregnant, or are pregnant or breastfeeding;
· Women with estrogen receptor-positive tumors;
· Postmenopausal women on anti-oestrogen therapy (like tamoxifen and aromatase
blockers) for estrogen-responsive breast cancer;
· Participation in another drug-investigating clinical study at the start or within four
weeks prior to the start;
· Inability to follow instructions of the investigator.
Opzet
Deelname
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Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6193 |
| NTR-old | NTR6515 |
| CCMO | NL57585.041.16 |
| OMON | NL-OMON45929 |