Acetylcysteine for Treatment of Sickle Cell Disease - N-acetylcystein for Sickle Cell Disease

• Conditions: Patients homozygous for sickle cell disease; MedDRA version: 8.1Level: LLTClassification code 10040644Term: Sickle cell disease

• Registration Number: EUCTR2006-005889-40-NL
• Lead Sponsor: Academic Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Ten patients with SCD (HbSS HbSC or HbSb) will be included.
Inclusion criteria
1.High performance liquid chromatography confirmed diagnosis of HbSS HbSC or HbSb genotype
2.Aged 18-65 years
3.Written 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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
1.Bloodtransfusion in the preceding four months
2.Pregnancy or the desire to get pregnant in the following 7 months
3.Concommitant use of hydroxyurea, vitamin K antagonists or other oral anticoagulants, or contraindications for NAC.
4.Impaired renal function of more than 60% (as assessed by the Kockroft-Gauld equation)
5.Known gatsric or duodenal ulcer
6.Concomittant use of anti-hypertensives, sildefanil or nitrates.

Study & Design

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