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Genistein as an add-on treatment for CF?


- candidate number27382
- NTR NumberNTR6515
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jun-2017
- Secondary IDsNL57585.041.16 
- Public TitleGenistein as an add-on treatment for CF?
- Scientific TitleGenistein as an add-on treatment for CF?
- ACRONYMThe TRIO study
- hypothesisAdding 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.
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF)
- Inclusion criteria∑ 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).
- Exclusion criteria∑ 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-jun-2017
- planned closingdate1-jun-2018
- Target number of participants20
- InterventionsGenistein or Placebo
- Primary outcomeThe main study parameter is pulmonary function (%FEV1) measured before and after the use of genistein and before and after the use of placebo.
- Secondary outcome∑ Sweat chloride concentration (SCC), before and after the use of genistein and placebo;
∑ Airway resistance (Rint and bodybox), before and after the use of genistein and placebo;
∑ BMI (=weight (in Kg)/Length2 (in cm)) before and after the use of genistein and placebo;
∑ Quality of life (measured with CFQ-questionnaire) before and after the use of genistein and placebo;
∑ Elastase measurements in the feces before and after the use of genistein and placebo;
∑ The CFTR stimulating ability of the concentration of genistein in the patientís blood samples, examined by in vitro testing (in the organoid model). We will also determine the plasma levels of genistein by HPLC;

Exploratory endpoint:
∑ Assessment of Ŗ-adrenergic sweat secretion by evaporimetry, before and after the use of genistein and placebo.
- Timepoints- Before placebo
- After using placebo for 8 weeks
- Before genistein
- After using genistein for 8 weeks
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES G. Berkers
- CONTACT for SCIENTIFIC QUERIES G. Berkers
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD13-jun-2017 - 11-jul-2017


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