Rare Iron Overloads Except C282Y Homozygosity : Description and Characterization. (HEPCIDEF)
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ClinicalTrials.gov Identifier: NCT01541813 |
Recruitment Status
:
Terminated
(rare overload and low recruitment)
First Posted
: March 1, 2012
Last Update Posted
: March 10, 2015
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Sponsor:
Rennes University Hospital
Information provided by (Responsible Party):
Rennes University Hospital
Tracking Information | ||||
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First Submitted Date | February 24, 2012 | |||
First Posted Date | March 1, 2012 | |||
Last Update Posted Date | March 10, 2015 | |||
Study Start Date | March 2011 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures | Not Provided | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT01541813 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Rare Iron Overloads Except C282Y Homozygosity : Description and Characterization. | |||
Official Title | Clinical, Biological, Genetic and Functional Characterization of Rare Iron Overload Phenotypes Associated With Hepcidin Deficiency Except C282Y Homozygosity. | |||
Brief Summary | Chronic iron overload is responsible for morbidity and mortality. There are many genetic and acquired causes. One of them is an hepcidin deficiency. Hepcidin is the regulating hormone for iron. The study explores this specific cause, and aim to characterize this iron overload in term of clinical, biological, genetic and functional specificities. | |||
Detailed Description | One of chronic iron overload profiles is a deficit in hepcidin. Hepcidin is the regulating hormone for iron. This specific profile is characterized by an elevated serum iron, an elevated transferrin saturation, and parenchymal damages of iron overload. This disease is not connected with known mutations of iron metabolism genes. The main objective of this study is the clinical, biological, genetic and functional characterization of rare iron overload phenotypes associated with hepcidin deficiency except C282Y homozygosity. |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Patients with a rare iron overloads except C282Y homozygosity. | |||
Condition | Rare Iron Overloads Except C282Y Homozygosity | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | iron overloads except C282Y homozygosity
Patients with an iron overloads except C282Y homozygosity |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Terminated | |||
Actual Enrollment |
62 | |||
Original Estimated Enrollment |
200 | |||
Actual Study Completion Date | December 2014 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion criteria:
Non inclusion criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01541813 | |||
Other Study ID Numbers | Afssaps 201O-A00866-33 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Rennes University Hospital | |||
Study Sponsor | Rennes University Hospital | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Rennes University Hospital | |||
Verification Date | August 2014 |