Extension study of efficacy and safety of LTP001 in pulmonary arterial hypertension participants

Phase 1

• Conditions: Pulmonary arterial hypertension; MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2022-002007-38-NL
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-16
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Written informed consent must be obtained before any assessment is performed.
• Participant is currently completing the Novartis-sponsored study
CLTP001A12201 in PAH and completed key efficacy and safety
procedures up to the end of treatment of the parent study, without
meeting discontinuation criteria in the parent study.
• Willingness and ability to comply with scheduled visits, treatment
plans and any other study procedures.
• In the opinion of the Investigator the participant would benefit from
LTP001 treatment.

Additional protocol-defined criteria may apply.
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 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

• History of hypersensitivity to the study treatment.
• Required or planned transplant or heart/lung surgery.
• Acute or chronic impairment (other than dyspnea), which would limit the ability to comply with study requirements, including interference with physical activity or execution of study procedures such as 6MWT (e.g., angina pectoris, claudication, musculoskeletal disorder, need for walking aids).
• Permanent discontinuation of Novartis drug in the parent study due to toxicity or disease progression, non-compliance to study procedures, withdrawal of consent or any other reason.

Additional protocol-defined criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the long-term safety of LTP001 in participants with pulmonary arterial hypertension (PAH);Secondary Objective: - To assess the effect of LTP001 on hemodynamic parameters derived from RHC <br>- To assess the effect of LTP001 on the 6MWD<br>- To assess the effect of LTP001 on measurements of right ventricular function <br>- To assess the impact of LTP001 on Time to Clinical Worsening <br>- To assess the impact of LTP001 on patient reported outcomes<br>- To assess the impact of LTP001 on the N-terminal fragment of the prohormone B-type natriuretic peptide <br>;Primary end point(s): AEs, SAEs, vital signs, ECGs, safety laboratory measurements;Timepoint(s) of evaluation of this end point: From Baseline to End-Of-Study