drugset / Trial / NCT05079126

Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease

NCT05079126

Phase 2 Terminated 18 enrolled Diffusion Pharmaceuticals Inc
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, placebo-controlled study of Trans Sodium Crocetinate (TSC) in patients with Interstitial Lung Disease (ILD), age 30-85 (inclusive). The primary objective of the study is to determine the effect of TSC on lung function as measured by diffusing capacity of the lungs for carbon monoxide (DLCO) in patients with ILD; the secondary objectives are to determine the effect of TSC on the 6-minute walk test (6MWT), heart rate recovery (HRR), and Borg Scale in patients with ILD.

Timeline

Start
2021-12-02
Primary completion
2022-05-25
Completion
2022-05-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Trans Sodium Crocetinate Other / unclassified 2.5 mg/kg Intravenous