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

Hereditary Hemochromatosis Clinical Trial

Official title:
A Phase II, Multicenter, Open-label, Randomized Two-year Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis.

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of deferasirox film coated tablet (FCT) versus phlebotomy for the management of iron overload in adults with HH at risk of iron-related morbidity. This evaluation will provide 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03203850
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 2
Start date	January 11, 2018
Completion date	April 17, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03395704` - A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis	Phase 2
Unknown status	`NCT01398644` - Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Hereditary Hemochromatosis (HH) Patients	Phase 3
Terminated	`NCT05238207` - A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers	Phase 1
Completed	`NCT04202965` - PTG-300 in Subjects With Hereditary Hemochromatosis	Phase 2
Enrolling by invitation	`NCT05742035` - Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.	N/A
Completed	`NCT00068159` - Cardiac Function in Patients With Hereditary Hemochromatosis
Completed	`NCT00395629` - Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis	Phase 1/Phase 2
Completed	`NCT00440986` - Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis	Phase 2/Phase 3