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

NCT03371173 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-04-21

No results posted yet for this study

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.

Conditions

  • Hypertension, Pulmonary
  • Anemia, Iron Deficiency

Interventions

DRUG

Ferric maltol 30 mg (Feraccru®)

Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects

Sponsors & Collaborators

  • Shields, Shields and Associates

    collaborator OTHER

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Marius Hoeper, Prof. Dr. · Hannover Medical School, Department of Pneumology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Germany

Study Locations

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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 NCT03371173 on ClinicalTrials.gov