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Hereditary Hemochromatosis clinical trials

View clinical trials related to Hereditary Hemochromatosis.

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NCT ID: NCT05742035 Enrolling by invitation - Clinical trials for Hereditary Hemochromatosis

Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.

Start date: January 18, 2023
Phase: N/A
Study type: Interventional

Iron overload in hereditary hemochromatosis (HH) is treated by phlebotomy. It is unclear, if individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes are suitable as blood donors. The study investigates hemolysis and several other quality parameters of red blood cell concentrates (RBC) obtained from 80 individual with ferritin >500 ng/mL - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control.

NCT ID: NCT05238207 Terminated - Clinical trials for Hereditary Hemochromatosis

A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers

Start date: March 28, 2022
Phase: Phase 1
Study type: Interventional

This is a first in human, double-blind, randomized, placebo-controlled, two-arm crossover study evaluating the safety, tolerability and PD of ascending dose levels of BBI-001 after: - a single administration in iron deficient male and female participants, and male and female HH patients (Part A), - two administrations per day in HH patients (Part B). BBI-001 administrations will be accompanied with consumption of a meal enriched with stable iron isotope Fe57, while corresponding placebo dose administrations will be with a meal enriched with stable iron isotope Fe58.

NCT ID: NCT04202965 Completed - Clinical trials for Hereditary Hemochromatosis

PTG-300 in Subjects With Hereditary Hemochromatosis

Start date: March 19, 2020
Phase: Phase 2
Study type: Interventional

This study will be conducted at multiple sites and every patient will get treated with PTG-300. The objective of the study is to assess the effect of PTG-300 in treating adult hereditary hemochromatosis patients.

NCT ID: NCT03395704 Completed - Clinical trials for Hereditary Hemochromatosis

A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis

Start date: November 29, 2017
Phase: Phase 2
Study type: Interventional

This study is a Phase 2 multicenter, randomized, placebo controlled, single-blind study. The primary objective of the study is to compare the effect of weekly dosing of LJPC-401 (synthetic human hepcidin) versus placebo on transferrin saturation (TSAT) in an adult hereditary hemochromatosis patient population.

NCT ID: NCT03203850 Terminated - Clinical trials for Hereditary Hemochromatosis

Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis (HH)

Start date: January 11, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of deferasirox film coated tablet (FCT) versus phlebotomy for the management of iron overload in adults with Hereditary Hemochromatosis (HH) at risk of iron-related morbidity. This evaluation provided information on the two treatment options in terms of the rate of response of proportion of patients reaching the study target SF ≤ 100 μg/L and their associated safety profiles. In addition to exploring the safety and efficacy of deferasirox FCT in hereditary hemochromatosis (HH), this study is being conducted to fulfill an FDA post-marketing requirement [PMC 750-10 (Exjade) /PMR 2888-8 (Jadenu)] to provide additional randomized data to confirm the ocular safety profile of deferasirox through detailed ocular assessments in patients treated with deferasirox FCT for 2 years.

NCT ID: NCT01398644 Unknown status - Clinical trials for Hereditary Hemochromatosis

Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Hereditary Hemochromatosis (HH) Patients

Start date: May 2008
Phase: Phase 3
Study type: Interventional

Hereditary hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in excessive iron overload. Phlebotomy is currently the standard therapy. More recently Therapeutic Erythrocytapheresis (TE) has become a new therapeutic modality, which potentially offers a more efficient method to remove iron overload with fewer procedures.In the proposed clinical trial the investigators will examine whether TE can keep the ferritin levels in patients requiring maintenance therapy below 50 microg/L, with minimally half the number of treatment procedures when compared to current standard therapy by P.

NCT ID: NCT00440986 Completed - Clinical trials for Hereditary Hemochromatosis

Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

Start date: April 2003
Phase: Phase 2/Phase 3
Study type: Interventional

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

NCT ID: NCT00395629 Completed - Iron Overload Clinical Trials

Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis

Start date: August 2006
Phase: Phase 1/Phase 2
Study type: Interventional

Brief Summary: This study was designed to explore a safe dose and characterize the preliminary safety and efficacy of ICL670 in adult patients with previously documented history of homozygous C282Y.

NCT ID: NCT00068159 Completed - Clinical trials for Hereditary Hemochromatosis

Cardiac Function in Patients With Hereditary Hemochromatosis

Start date: December 8, 2003
Phase:
Study type: Observational

This study will examine the effect of iron buildup in the hearts of patients with hereditary hemochromatosis (HH), a genetic disease that causes the body to accumulate excess amounts of iron. The excess iron can damage the heart, liver, pancreas, skin, and joints. Generally, early treatment with phlebotomy (periodic removal of a unit of blood), and in some cases chelation (using a drug to remove iron from the body) slows down organ damage in HH patients. This study will try to elucidate the effect of iron buildup in the heart and determine if phlebotomy and chelation help keep the heart healthy. Patients with HH and healthy volunteers 21 years of age and older may be eligible for this study. (Normal volunteers will provide normal values of heart function that will be used to verify abnormalities detected in HH patients.) Patients must have a gene abnormality of Hfe gene Cys282Try homozygote. They may or may not be receiving treatment for HH and they must have no heart symptoms or serious organ damage due to HH. Candidates will be screened with a medical history and physical examination, blood tests, electrocardiogram (EKG), Holter EKG (24-hour EKG monitoring, see description below), and chest x-ray. Participants will undergo the following tests and procedures over 2 to 5 days: - Exercise test: The participant exercises on a treadmill while wearing a mouthpiece, which is used to measure how much oxygen is used. Electrodes placed on the chest and arms monitor the heartbeat during the test. - Echocardiography: This ultrasound test uses sound waves to take pictures. A small probe is held against the chest to allow a technician to take pictures of the heart and assess its function. A drug called Optison may be injected in an arm vein if needed to enhance the ultrasound images. - Exercise stress echocardiography: The participant exercises on a stationary bike while heart function is measured with an echocardiogram, EKG, and blood pressure cuff. - 24-hour Holter EKG: The participant wears a small machine that records heart rhythm continuously for 24 hours. The recorder is connected by cables to electrodes placed on the chest. - Magnetic resonance imaging: This test uses a magnetic field and radio waves to obtain detailed images of the heart and blood vessels. The participant lies flat on a table that slides inside the scanner, which is a large hollow tube. All tests are performed once in normal volunteers and in patients who have received standard treatment for HH. Untreated patients repeat the tests 6 months after beginning phlebotomy or chelation. Additional time points for these tests might be added if further evaluation is needed.