TerminatedPhase 2

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

Stopped: Due to enrolment challenge

Belgium, France, Romania45 participantsStarted 2018-01-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Medical conditions that preclude inclusion:
✕. Concomitant therapy that precludes enrollment:
✕. Abnormal Laboratory Values:
✕. Participation in an investigational study:
✕. Pregnancy and contraception:

What they're measuring

Proportion of Patients Achieving Target SF ≤ 100 μg/L for the First Time

Timeframe: Up to Month 24

Trial details

NCT IDNCT03203850

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-17

Results submitted2024-04-10

View on ClinicalTrials.gov More Hereditary Hemochromatosis trials