Genistein as an add-on treatment for CF?

Phase 1

• Conditions: Cystic Fibrosis; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2016-001619-19-NL
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-27
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•CFTR genotype associated with residual CFTR function;
•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).

Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 tamoxifen therapy 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified