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

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03381833 on ClinicalTrials.gov