FindTrial
Sign In

An Open-Label Extension Study Evaluating the Long-Term Safety of ICA 17043 with or without Hydroxyurea Therapy in Subjects with Sickle Cell Disease

An Open-Label Extension Study Evaluating the Long-Term Safety of ICA 17043 with or without Hydroxyurea Therapy in Subjects with Sickle Cell Disease

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001652-12-FR
Enrollment
300
Registered
2006-10-30
Start date
Unknown
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Interventions

Product Name: Bis (4-fluorophenyl)phenyl acetamide Product Code: ICA-17043 Pharmaceutical Form: Tablet CAS Number: 289656-45-7 Current Sponsor code: ICA-17043 Other descriptive name: Bis(4-fluoropheny

Sponsors

Icagen Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

MeasureTime frame
Main Objective: The objective of this study is to determine the long-term safety (=2 years including Study 10 exposure) of ICA 17043, with or without HU as background therapy, in subjects with SCD.;Secondary Objective: ;Primary end point(s): Monitoring long term safety—

Countries

France, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026