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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00138684
Other study ID # DGS 2003/0052
Secondary ID PHRC/02-09CIC020
Status Completed
Phase Phase 2
First received August 29, 2005
Last updated May 18, 2012
Start date September 2003
Est. completion date February 2006

Study information

Verified date May 2012
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

The aim of the study is to determine, in patients presenting hepatic iron overload (genetic haemochtomatisis or dysmetabolic iron overload syndrome), the effects of venesection therapy on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone before and after venesection.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 2006
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Male patients aged from 18 to 70 years

- Hepatic iron overload measured by magnetic resonance imaging [MRI] (> 36 µmol/g and < 200 µmol/L)

- Homozygosity for the C282Y mutation of the HFE or dysmetabolic iron overload syndrome (DIOS) based on the presence of at least one of these following metabolic abnormalities:

- Overweight: BMI > 25 kg/m2

- Waist/hip circumference (cm) > 0.90

- Diabetes mellitus (fasting blood glucose level >1.25g/L or blood glucose level after 2 hours > 2g/L) or glucose intolerance (fasting blood glucose level between 1.10 and 1.25g/L)

- Total cholesterolemia > 6.2 mmol/L or HDL-Cholesterol < 0.9 mmol/L

- TG>= 1.7 mmol

- Written informed consent

Non-Inclusion Criteria:

- Consumption of alcohol > 50 g/day and of any CYP2E1 inhibitor substances

- Smoker > 5 cigarets/day

- History of blood donation or venesection

- Other causes of iron overload: aceruloplasminaemia, haematological disorder (abnormal blood counting), late cutaneous porphyria (cutaneous bullous disorders and photosensibilisation) , martial treatment, repeated transfusions.

- Inflammatory syndrome (CRP > 3ng/ml)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
venesection
Venesection therapy is realised every 7 - 14 days until iron desaturation completion.

Locations

Country Name City State
France CHU Nantes Nantes
France Unité d'Investigation Clinique - Hôpital Pontchaillou Rennes

Sponsors (2)

Lead Sponsor Collaborator
Rennes University Hospital Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary variation of chlorzoxazone metabolization rate measured before and after venesection Baseline and after iron desaturation completion No
Secondary variation of blood Malonedialdehyde rate Baseline and after iron desaturation completion No
Secondary variation of blood 4-hydroxynonenal rate Baseline and after iron desaturation completion No
Secondary variation of blood Glutathion rate Baseline and after iron desaturation completion No
Secondary variation of serum Vitamin E rate Baseline and after iron desaturation completion No
Secondary Variation of serum Vitamin C rate Baseline and after iron desaturation completion No
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