ORal IrON Supplementation With Ferric Maltol in Patients With Pulmonary Hypertension (ORION-PH-1)

Phase 3 Terminated 22 enrolled Hannover Medical School Shields, Shields and Associates · collab

NaSingle-groupOpen-labelTreatment

Summary

This is an explorative, open-label, uncontrolled, single center study to explore the preliminary safety, tolerability and efficacy of oral ferric maltol in treating iron deficiency in patients with pulmonary hypertension and iron deficiency anemia.

Timeline

Start: 2018-03-27
Primary completion: 2020-03-19
Completion: 2020-03-19

Outcome

Outcome not reported

Stopped (Enrollment): “low recruitment rate; difficulties to achieve planned number of participants within reasonable time frame”

Publications

Olsson KM, Fuge J, Brod T, Kamp JC, Schmitto J, Kempf T, Bauersachs J, Hoeper MM. Oral iron supplementation with ferric maltol in patients with pulmonary hypertension. Eur Respir J. 2020 Nov 12;56(5):2000616. doi: 10.1183/13993003.00616-2020. Print 2020 Nov.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ferric maltol	Small molecule	30 mg	Oral