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Clinical Trial Summary

This is a multi-center, Phase 2 Long-Term Extension Study to assess the safety, tolerability, and efficacy of PB1046 at an optimally titrated dose. This is a Long-Term Extension Study for subjects with pulmonary arterial hypertension (PAH), having participated in double-blind Study PB1046-PT-CL-0004 or open-label Study PB1046-PT-CL-0005. The study will include adult subjects previously diagnosed with symptomatic PAH, who are receiving background clinician-directed therapy for PAH.

All subjects during the Long-Term Dosing and Safety Follow-Up Period, will continue to be followed for safety and tolerability, as well as for periodic efficacy, quality of life data and immunogenicity. The study will continue until such time when PB1046 becomes commercially available to the subject or the Sponsor terminates the study due to lack of efficacy, safety or other reasons.

Clinical Trial Description

Subjects entering this study will enter from the double-blind Study PB1046-PT-CL-0004 or from open-label Study PB1046-PT-CL-0005. The starting dose level of PB1046 for all subjects in these parent studies was a sub-therapeutic or minimally effective dose (MED) of 0.2 mg/kg, administered by subcutaneous injection.

In the PB1046-PT-CL-0004 Study, subjects were randomized into either the minimally effective dose (MED) Group or a dose-titration group. In the dose-titration group, individual subjects were titrated up to their maximum tolerated dose (MTD) in a blinded fashion, with the objective of titrating subjects up to a dose of at least 1.2 mg/kg or higher in the MTD Group, while subjects in the MED Group remained at the minimally effective dose level of 0.2 mg/kg, and underwent "sham dose-titration" to maintain the blind.

Subjects entering this study from PB1046-PT-CL-0004 will remain blinded at the start of this study to protect the blind of the 0004 Study, until the database for the 0004 Study is locked through Week 17.

Subjects in the 0005 Study were up-titrated to a maximum tolerated dose in an open-label design. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03795428
Study type Interventional
Source PhaseBio Pharmaceuticals Inc.
Status Not yet recruiting
Phase Phase 2
Start date January 15, 2019
Completion date February 15, 2024

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