A one year open label, non comparative extension to a randomised, multicentre, phase II study to evaluate the asfety, tolerability, pharmacokinetics and effects on iron concentration of repeated doses of 5-10 mg/kg/day of ICL670 relative to deferoxamine in sickle cell disease patients with transfusional hemosiderosis -

Phase 1

• Conditions: Sickle cell disease patients with transfusional hemosiderosis

• Registration Number: EUCTR2004-000597-31-GB
• Lead Sponsor: ovartis Pharmaceuticals UK Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-14
• Study Completion: 2009-07-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Completion of the core study 0109, including the week 52 SQUID assessment

Serum ferritin greater or equal to 500mcg/L

Ability to comply with all study-related procedures, medications and evaluations.

Sexually active post-menarche female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months

Written informed consent and assent by patient and or their parents or legal guardian.
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

History of non compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative.

Serum creatine above the age-appropriate upper limit of normal within one week prior to entry.

Patients with ALT>=500U/L within one week prior to entry.

Evidence of chelation-related cataracts or hearing loss within 4 weeks prior to baseline.

Pregnancy (as indicated by serum B HCG pregnancy test for all female patients with the potential to become pregnant) and patients who are breast feeding.

Patients treated with systemic investigational drug within 4 weeks prior to or with topical investigational drug within 7 days prior to the baseline visit.

Study & Design

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