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OpenTrials
Completed

NCT Number: NCT00440986

Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

The purpose of study is to determine the best and durable choice of treatment between phlebotomy and eritrocytoapheresis in the medium- and long-term clinical management of HH

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Key information

Conditions

Hereditary Hemochromatosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hemochromatosis Iron Metabolism Disorders Iron Overload Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Transfusion Medicine-San Filippo Neri General Hospital

Rome, 00135, Italy

About this study

Patients affected by Hereditary hemochromatosis need a completeinitial staging of disease, a correct clinical management, a good chance of treatment and long-term follow-up. Clinical manifestations at presentation and during follow-up may consistently vary according to diagnostic criteria, treatment options and follow-up durability, up to the interruption. So, 25 caucasian patients, 16 males and 6 females of age >18 yrs. have been consecutively diagnosed and randomly included into two arms of treatment, phlebotomy vs. eritrocytoapheresis, evaluating, at baseline and 6-12-18-24-36 months, the clinical status concerning liver, kidney, pancreas, heart, endocrine iron overload and function and final outcome related to therapeutic strategy, including the cost/effectiveness analysis

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patiens newly diagnosed having Hereditary Hemochromatosis

Exclusion criteria

  • Age < 18 yrs.
  • Not obese (BMI <30)
  • Not consuming alchol beverages,
  • Not affected by systemic diseases and known hepatic viruses

Treatment and study plan

Eritrocytoapheresis

Procedure

Primary outcomes

  1. To prospectively determine the best choice of tretment in HH

  2. To evaluate the global outcome according to treatment choice

Secondary outcomes

  1. To evaluate the outcome of specific clinical features according to treatment choice

Sponsors and collaborators

Lead sponsor

San Filippo Neri General Hospital

Other

Registry information

Important dates

Study start
2003
Study completion
2006
First posted
Feb 27, 2007
Registry last updated
Mar 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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