| 1 |
NCT01810965 |
Recruiting |
Impact of Bloodletting on Iron Metabolism in Type 1 Hemochromatosis |
|
- Procedure: First evaluation phase : no intervention / Second evaluation phase: bloodletting of 7 ml/kg (with a maximum of 500ml)
|
Interventional
|
Not Applicable |
- Rennes University Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximal variation (delta maximum) of NTBI during the 5 days following a bloodletting
- Kinetic of NTBI plasmatic concentration during the 5 days following a bloodletting
- Maximal variation (delta maximum) of LPI during the 5 days following a bloodletting
- (and 12 more...)
|
14 |
Male |
18 Years and older (Adult, Older Adult) |
NCT01810965 |
ANSM 2012-A01392-41 |
SAIFER |
June 3, 2013 |
September 2018 |
September 2018 |
March 14, 2013 |
September 27, 2017 |
|
- CHU Pontchaillou
Rennes, France
|
|
| 2 |
NCT03203850 |
Recruiting |
A Two-year Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis. |
- Hereditary Hemochromatosis
|
- Drug: Deferasirox FCT
- Procedure: No Drug
|
Interventional
|
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients achieving target SF ≤ 100 μg/L for the first time.
- Incidence of ocular adverse events (AEs) overall
- Incidence of ocular adverse events (AEs) by severity
|
150 |
All |
18 Years and older (Adult, Older Adult) |
NCT03203850 |
CICL670F2203 |
|
January 11, 2018 |
March 10, 2022 |
March 10, 2022 |
June 29, 2017 |
June 18, 2018 |
|
- Novartis Investigative Site
Leuven, Belgium - Novartis Investigative Site
Manresa, Espana, Spain - Novartis Investigative Site
Barcelona, Spain - (and 3 more...)
|
|
| 3 |
NCT03356548 |
Recruiting |
Transferrin Saturation and Asthenia in Hemochromatosis |
|
|
Observational
|
|
- Rennes University Hospital
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Quality of life questionnaire SF 36
- Biological markers : Transferrin Saturation Coefficient
|
300 |
All |
18 Years and older (Adult, Older Adult) |
NCT03356548 |
35RC17_3067_HEMOSAT |
HEMOSAT |
May 10, 2017 |
July 2018 |
July 2018 |
November 29, 2017 |
November 29, 2017 |
|
- Rennes University Hospital
Rennes, Britain, France
|
|
| 4 |
NCT03395704 |
Recruiting |
A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis |
- Hereditary Hemochromatosis
|
- Drug: LJPC-401
- Drug: Placebo
|
Interventional
|
Phase 2 |
- La Jolla Pharmaceutical Company
- PRA Health Sciences
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Effect of LJPC-401 on blood iron levels
- Effect of LJPC-401 on clinical chemistry laboratory parameters
- Effect of LJPC-401 on hematology laboratory parameters
- (and 11 more...)
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT03395704 |
LJ401-HH01 |
|
November 29, 2017 |
October 2018 |
December 2018 |
January 10, 2018 |
April 26, 2018 |
|
- Investigative Site
North Little Rock, Arkansas, United States - Investigative Site
Rialto, California, United States - Investigational Site
San Diego, California, United States - (and 3 more...)
|
|
| 5 |
NCT00007150 |
Recruiting |
Treatment of Hemochromatosis |
|
|
Observational
|
|
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To prospectively study the response to to phlebotomy therapy in patients with hereditary hemochromatosis using changes in the MCV/hemoglobin as the primary monitoring guide for the pace of iron-depletion, to compare the efficacy of the MCV gu...
- To prospectively evaluate the effect of maintaining a long-term state of borderline iron-limited erythropoiesis (MCV 1-3% below baseline) on the frequency of phlebotomy during the maintenance phase oftherapy and on the progression of hemoc...
- To establish a program to make blood therapeutically withdrawn fromhemochromatosis subjects available for allogeneic transfusion to patients in the Clinical Center, NIH.
- To prospectively evaluate the effect of maintaining a long-term state of iron-limited erythropoiesis on the progression of hemochromatosis-associated cirrhosis.
|
99999999 |
All |
15 Years and older (Child, Adult, Older Adult) |
NCT00007150 |
010045
01-CC-0045 |
|
December 7, 2000 |
|
|
December 11, 2000 |
June 14, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 6 |
NCT02263638 |
Recruiting |
Treatment of Refractory Hemochromatosis Rheumatism by Anakinra: a Preliminary Phase II Study |
- Refractory Hemochromatosis Rheumatism
|
|
Interventional
|
Phase 2 |
- Rennes University Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of patients with improvement of joint pain
- Assessment of the disease activity
- Assessment of the number of painful joints
- (and 16 more...)
|
56 |
All |
18 Years and older (Adult, Older Adult) |
NCT02263638 |
2014-000609-10
35RC13_8811_THERA |
THERA |
February 4, 2015 |
February 2019 |
May 2019 |
October 13, 2014 |
July 5, 2017 |
|
- CHRU de Lille
Lille, France - Groupe Hospitalier Lariboisière
Paris, France - Rennes University Hospital
Rennes, France
|
|
| 7 |
NCT01949467 |
Recruiting |
Analysis of the Modulation of Serum Hepcidin Level in Response to Iron Oral Intake: Potential Interest for the Differential Diagnosis Between Ferroportin Disease and Dysmetabolic Hepatosiderosis. |
- Hemochromatosis, Type 4
- Ferroportin Disease
- Dysmetabolic Hepatosiderosis
- Diagnosis
|
|
Interventional
|
Phase 2 |
- Rennes University Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- hepcidemia rate
- ratios between serum hepcidin level and iron parameters
- serum level of other divalent cations
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT01949467 |
FERHEP |
|
February 10, 2014 |
April 10, 2019 |
October 2019 |
September 24, 2013 |
May 31, 2017 |
|
- CHU Clermont-Ferrand
Clermont-Ferrand, France - CHU Limoges
Limoges, France - CHU Montpellier
Montpellier, France - (and 3 more...)
|
|
| 8 |
NCT02025543 |
Recruiting |
Confounder-Corrected Quantitative MRI Biomarker of Hepatic Iron Content |
- Iron Overload
- Hemochromatosis
- Hemosiderosis
|
|
Observational
|
|
- University of Wisconsin, Madison
- Johns Hopkins University
- Stanford University
- University of Texas
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Primary Outcome Measure
- Precision Outcome Measure
- Accuracy Outcome Measure
- Robustness Outcome Measure
|
200 |
All |
10 Years to 89 Years (Child, Adult, Older Adult) |
NCT02025543 |
2013-1174 |
|
December 2013 |
December 2019 |
December 2020 |
January 1, 2014 |
March 14, 2018 |
|
- Stanford University
Palo Alto, California, United States - Johns Hopkins University
Baltimore, Maryland, United States - University of Texas-Southwestern
Dallas, Texas, United States - University of Wisconsin, Madison
Madison, Wisconsin, United States
|
|
| 9 |
NCT03453918 |
Recruiting |
Effects of Polyphenols on Iron Absorption in Iron Overload Disorders. |
- Dysmetabolic Iron Overload Syndrome
- Genetic Hemochromatosis
- Iron Absorption
- Polyphenols
|
- Dietary Supplement: polyphenols
- Other: Placebo
|
Interventional
|
Not Applicable |
- University Hospital, Clermont-Ferrand
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Decrease of post-prandial iron absorption after dietary polyphenol supplementation
- Post-prandial changes of circulating oxylipin in iron overload diseases after iron-rich meal and effects of polyphenols supplementation
- Comparison of oxylipin levels between DIOS, genetic hemochromatosis and healthy subjects after 6 hours of fasting.
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03453918 |
CHU-381
2017-A01955-48 |
POLYFER |
April 9, 2018 |
October 30, 2018 |
October 30, 2018 |
March 5, 2018 |
April 10, 2018 |
|
- CHU Clermont-Ferrand
Clermont-Ferrand, France
|
|
| 10 |
NCT00001971 |
Recruiting |
Evaluation of Patients With Liver Disease |
- Biliary Liver Cirrhosis
- Hemochromatosis
- Hepatitis
- (and 2 more...)
|
|
Observational
|
|
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
99999999 |
All |
2 Years and older (Child, Adult, Older Adult) |
NCT00001971 |
910214
91-DK-0214 |
|
September 10, 1991 |
|
|
January 19, 2000 |
May 3, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 11 |
NCT03131427 |
Recruiting |
China Registry for Genetic / Metabolic Liver Diseases |
- Genetic/Metabolic Liver Diseases
|
|
Observational
|
|
- Beijing Friendship Hospital
- Beijing YouAn Hospital
- Henan Provincial Hospital
- (and 10 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- rate of liver-related events of each disease.
- Genotype profile in Chinese patients of each disease
- Natural history of Chinese patients with each disease of different genotype
- Causes of death in Chinese patients of each disease
|
20000 |
All |
Child, Adult, Older Adult |
NCT03131427 |
CR-GMLD |
|
June 13, 2015 |
April 28, 2022 |
April 28, 2027 |
April 27, 2017 |
April 27, 2017 |
|
- Beijing Ditan Hospital
Beijing, Beijing, China - Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing, China - Peking University First Hospital
Beijing, Beijing, China - (and 9 more...)
|
|
| 12 |
NCT02007746 |
Recruiting |
Liver Fibrosis in Sickle Cell Disease |
|
- Other: Liver transient elastography (Fibroscan)
- Other: Ferriscan
- Procedure: Liver biopsy in iron overloaded subjects.
|
Observational
|
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- Liver transient elastography (FibroScan) of liver iron content and stiffness
- magnetic resonance imaging (MRI) measure of liver iron content and stiffness
- liver function tests (ALT, AST, serum alkaline phosphate, GGTP, total bilirubin, direct bilirubin), complete blood count, platelets, reticulocyte count, serum ferritin to assess liver function and evaluate overall health
|
30 |
All |
10 Years to 65 Years (Child, Adult, Older Adult) |
NCT02007746 |
20120222 |
|
July 2012 |
December 31, 2018 |
December 31, 2019 |
December 11, 2013 |
March 30, 2018 |
|
- University of Miami
Miami, Florida, United States
|
|
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