An Open-Label Extension Study Evaluating the Long-Term Safety of ICA 17043 with or without Hydroxyurea Therapy in Subjects with Sickle Cell Disease
- Conditions
- Sickle Cell Disease
- Registration Number
- EUCTR2006-001652-12-FR
- Lead Sponsor
- Icagen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 300
1. Subject has successfully completed Study 10;
2. Male, or female not capable of becoming pregnant or using appropriate birth control method. Acceptable methods - Postmenopausal as defined by absent menses for more than or equal to 12 months; Hysterectomy; Bilateral ovariectomy; Bilateral tubal ligation (if surgery more than or equal to 12 months previous); Hormonal contraception with 1 barrier method*; Double barrier method*; Abstinence;
*Barrier methods include use of a diaphragm or sponge with
spermicidal cream or jelly, and/or condom use by sexual partner
3. Has willingly given written informed consent to participate in this investigation.
Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
1. The subject, if female, has a positive urine pregnancy test (dipstick) on Day 1;
2. The subject is presently unsuitable for participation in this long-term study (e.g., safety considerations, planning surgery).
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