Comparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutation

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2014-000817-30-NL
• Date of registration: 22/05/2014
• Prospective Registration: Yes
• Primary sponsor: University Medical Centre Utrecht
• Public title: Comparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutation
• Scientific title: Comparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutation - TICTAC-study
• Date of first enrolment: 14/08/2014
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000817-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Netherlands

Contacts

• Name: Gitte Berkers
• Affiliation: University Medical Center Utrecht

• Name: Gitte Berkers
• Affiliation: University Medical Center Utrecht

Key inclusion & exclusion criteria

Inclusion criteria:
1. CFTR genotype compound/ S1251N
2. CFTR measurement available in intestinal biopsies
3. Males and females, aged 6 years or older on the date of informed consent or, where
appropriate, date of assent
4. Signed informed consent form (IC), and where appropriate, signed assent form

Are the trial subjects under 18? yes
Number of subjects for this age range: 7
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Severe acute exacerbation or pulmonary infection during last four weeks (needing intravenous
treatment);
2. Use of curcumin and or genistein at start or within four weeks prior to start of the study;
3. Participation in another drug-investigating clinical study at the start or within four weeks prior to the
start;
4. Inability to follow instructions of the investigator;
5. In case of (potential) pregnancy or breastfeeding.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Cystic Fibrosis

Intervention(s)

Trade Name: Ivacaftor/Kalydeco
Pharmaceutical Form: Film-coated tablet

Product Name: Curcuma Longa Extract cpl formaat 00 23,2 x 8,5 mm 723 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: curcumin
CAS Number: 458-37-7
Other descriptive name: CURCUMIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-

Product Name: Genisteine Plus 150 mg cpl formaat 1 18,7 x 6,4 mm 438 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: genistein
CAS Number: 446-72-0
Other descriptive name: GENISTEIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 48.5-

Primary Outcome(s)

Main Objective: Curcumin and genistein might be a cheap alternative for treating patients with a class III gating mutation

Main objective of the trial is to investigate the clinical response on treatment with curcumin and genistein in CF-patients with a class III S1251N mutation, relative to the clinical response on Ivacaftor therapy.

Secondary Objective: 1.To evaluate the correlations between individual curcumin+genistein and Ivacaftor induced CFTR function in vitro (organoid-based
measurements) and the in vivo treatment effect (lungfunction, airway resistance and SCC);
2.To assess whether the dosage of curcumin+genistein and Ivacaftor used in the clinical study is sufficient to stimulate CFTR function. We will
evaluate the CFTR stimulating ability of the concentration of curcumin+genistein and Ivacaftor in the patient’s blood samples. We will examine this by in vitro testing (in the organoid model), evaluating the CFTR stimulating ability of the concentration of curcumin+genistein and Ivacaftor in the patient’s blood samples.

Primary end point(s): Difference in lung function (%FEV1), airway resistance (Rint and bodybox) and sweat choline concentration:

Timepoint(s) of evaluation of this end point: - before and after receiving curcumin+genistein
- before and after treatment with Ivacaftor

Secondary Outcome(s)

Secondary end point(s): 1. Correlation between individual curcumin+genistein and Ivacaftor induced CFTR function in vitro (organoid-based measurements) and in vivo
effect (lung function, SCC);
2. The CFTR stimulating ability of the concentration of curcumin+genistein and Ivacaftor in the patient’s blood samples, examined by in vitro
testing (in the organoid model).
3. Difference in BMI;
4. Difference in quality of life (measured with CFQ-questionnaire) .

Timepoint(s) of evaluation of this end point: Before and after the use of curcumin+genistein and Ivacaftor.
The in vitro measurements of the first end point will be determined in the laboratory at any time during the trial.

Secondary ID(s)

TICTAC-2014

Source(s) of Monetary Support

NCFS