A study to identify whether it is safe, if it works, and how much and how often cysteamine should be given to adult patients with Cystic Fibrosis (CF) who are being treated for a worsening of CF associated lung disease.
- Conditions
- exacerbation of Cystic FibrosisTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2015-004986-99-GB
- Lead Sponsor
- ovaBiotics, Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1. CF-associated lung disease with documented history of chronic infection with Gram-negative organism(s)
2. Established patient of the Principal Investigator's CF Multi-Disciplinary team
3. Age equal or greater than 18 years
4. Weight equal or more than 40 Kg
5. FEV1 more than 30% of predicted within the 6 months prior to study exacerbation
6. At baseline visit: experiencing a new exacerbation of CF associated lung disease requiring treatment that includes an aminoglycoside antibiotic
7) Females of childbearing potential will be included if they are
either sexually inactive (sexually abstinent for 14 days prior to the
first study drug dose continuing through 28 days after the last
study drug dose, or using one of the following highly effective
contraceptive (i.e. results in <1% failure rate when used
consistently and correctly) methods in this trial:
a. intrauterine device (IUD);
b. surgical sterilization of the partner (vasectomy for 6 months
minimum);
c. combined (estrogen or progestogen containing) hormonal
contraception associated with the inhibition of ovulation
(either oral, intravaginal, or transdermal);
d. progestogen only hormonal contraception associated with the
inhibition of ovulation (either oral, injectable, or
implantable);
e. intrauterine hormone releasing system (IUS);
f. bilateral tubal occlusion.
Females of childbearing potential agree to remain sexually inactive or to keep the same birth control method for at least 28 days following
the last dose.
9) A female of non-childbearing potential must have undergone one
of the following sterilization procedures at least 6 months prior to
the first study drug dose:
a. hysteroscopic sterilization;
b. bilateral tubal ligation or bilateral salpingectomy;
c. hysterectomy;
d. bilateral oophorectomy;
or be postmenopausal with amenorrhea for at least 1 year prior
to the first study drug dose and follicle stimulating hormone
(FSH) serum levels consistent with postmenopausal status.
10) A non-vasectomized male subject agrees to use a condom with
spermicide or abstain from sexual intercourse during the study
until 90 days beyond the last dose of study medication and the
female partner agrees to comply with inclusion 7 or 9. For a
vasectomized male who has had his vasectomy 6 months or more
prior to study start, it is required that they use a condom during
sexual intercourse. A male who has been vasectomized less than 6
months prior to study start must follow the same restrictions as a
non-vasectomized male.
11) If male, agrees not to donate sperm from the first study drug dose until 90 days after dosing.
12) Willing and able to comply with all protocol requirements and
procedures, including induction of sputum, if necessary
13) Willing and able to provide signed and dated informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1. Hypersensitive to cysteamine or to any of the excipients
2. Hypersensitive to penicillamine
3. Transplant recipient
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method