A non-randomized, single-center, open, two-period study with paired design to compare measured steady-state treprostinil concentrations in human plasma under treatment with a 10 mg/ml treprostinil formulation and following a switch to a 20 mg/ml treprostinil formulation in patients with pulmonary arterial hypertension (PAH)

A single center, open-label, two-period, non-randomized, paired-design study to compare steady-state plasma levels following switch from a 10 mg/ml treprostinil formulation to a 20 mg/ml treprostinil formulation in patients with pulmonary arterial hypertension (PAH)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004002-21-AT

Enrollment

Registered

2021-09-06

Start date

2021-11-26

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary arterial hypertension MedDRA version: 21.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: 20 mg/ml Treprostinil Pharmaceutical Form: Solution for infusion INN or Proposed INN: treprostinil sodium CAS Number: 289480-64-4 Other descriptive name: TREPROSTINIL SODIUM Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed informed consent form - Male or Female, aged 18 years at screening or above - Patient is treated with 10 mg/ml treprostinil since at least two weeks on stable dose with no dose escalation planned for at least two more weeks - Patient is on stable dose of at least 15 ng/kg/min since at least 2 weeks with an even number as programmed flow rate - Patient is diagnosed with PAH (Group 1) - Patient is in stable health condition - Any concomitant medication has been maintained on stable dose since at least 72 hours Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients receiving any other strength of treprostinil - Patients diagnosed with any other form of PH (e.g. CTEPH) - Patient with signs of disease progression or worsening requiring up-titration of dose - Patient shows signs of acute infusion site infection - Patient reports infusion site pain scale > 3 (5-scale intensity score) at time of screening - Patient has a history of serious adverse drug reactions possibly related to treprostinil - Patient was diagnosed with severe hepatic or renal impairments or any other disease possibly impacting PK of treprostinil - History of non-compliance - Currently smoking > 10 cigarettes per day - History of alcohol or drug abuse - Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the interchangeability of 20 mg/ml treprostinil compared to a 10 mg/ml treprostinil formulation by using pharmacokinetic (PK) endpoints. ;Secondary Objective: To evaluate the comparability of local tolerance of 10 mg/ml treprostinil and 20 mg/ml treprostinil ;Primary end point(s): Average concentration of Treprostinil at steady state Cavgss (= AUC0-t / t) ;Timepoint(s) of evaluation of this end point: Average concentration over a period of 24 hours (24 hours period 1 and 24 hours period 2) Sampling will be performed after 0, 2, 4, 6, 8, 12, 24, 26, 28, 30, 32, 36, and 48 hours	—

Measure

Time frame

Main Objective: To evaluate the interchangeability of 20 mg/ml treprostinil compared to a 10 mg/ml treprostinil formulation by using pharmacokinetic (PK) endpoints. ;Secondary Objective: To evaluate the comparability of local tolerance of 10 mg/ml treprostinil and 20 mg/ml treprostinil ;Primary end point(s): Average concentration of Treprostinil at steady state Cavgss (= AUC0-t / t) ;Timepoint(s) of evaluation of this end point: Average concentration over a period of 24 hours (24 hours period 1 and 24 hours period 2) Sampling will be performed after 0, 2, 4, 6, 8, 12, 24, 26, 28, 30, 32, 36, and 48 hours

—

Secondary

Measure	Time frame
Secondary end point(s): - Number and frequency of local adverse drug reactions related to infusion site - Average pain scale score ;Timepoint(s) of evaluation of this end point: Adverse Drug Reactions will be monitored and reported throughout study participation Pain scale will be assessed after 4, 24, 28 and 48 hours	—

Countries

Austria

Contacts

Public ContactClinical Project Manager

AOP Orphan Pharmaceuticals GmbH

simone.pleifer-matzinger@aoporphan.com+4366488375206

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026