A Study With LJPC-401 for the Treatment of Myocardial Iron Overload in Patients With Transfusion-Dependent Beta Thalassemia
NCT03381833 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2021-07-29
Summary
This study is a Phase 2 multicenter, randomized, open-label, parallel-group study. The primary objective of the study is to evaluate the effect of LJPC-401 (synthetic human hepcidin) on iron levels in patients with transfusion-dependent beta thalassemia with myocardial iron overload.
Conditions
Interventions
- DRUG
-
LJPC-401
subcutaneous injection, up to 20 mg per week from week 26 to 52
- DRUG
-
LJPC-401
subcutaneous injection, up to 20 mg per week from week 1 to 52
Sponsors & Collaborators
-
La Jolla Pharmaceutical Company
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-30
- Primary Completion
- 2019-12-03
- Completion
- 2020-01-14
- FDA Drug
- Yes
Countries
- United States
- Australia
- Greece
- Italy
- Lebanon
- Thailand
- Turkey (Türkiye)
- United Kingdom
Study Locations
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