CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
LJPC-401 +1 moredrug
Likely dose
LJPC-401 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03395704
NCT03395704Phase 2Completed

A Phase 2, Multi-Center, Randomized, Placebo Controlled, Single-Blind Study With LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis

La Jolla Pharmaceutical Company·interventional·Posted Jan 10, 2018·Updated Jun 9, 2022

In Brief

A Phase 2 clinical trial evaluating LJPC-401 and Placebo for Hereditary Hemochromatosis. Completed, enrolled 70 participants across 31 sites in 4 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, France, United Kingdom, United States
CollaboratorsPRA Health Sciences

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 10, 2018
Enrollment StartNov 29, 2017
Primary CompletionOct 28, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.5 years ago

Interventions

LJPC-401drug

LJPC-401 subcutaneous injection, up to 20 mg weekly for 16 weeks. The minimum weekly dose will be 5 mg and the maximum weekly dose of LJPC-401 will be 20 mg.

Placebodrug

0.9% Sodium Chloride Injection, USP, or equivalent