Inhaled Treprostinil for Pulmonary Arterial Hypertension

Recruiting in Palo Alto (17 mi)

+24 other locations

Overseen byNicholas S Hill, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Liquidia Technologies, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to evaluate the long-term safety of LIQ861 in patients with pulmonary arterial hypertension (PAH).

Research Team

Nicholas S Hill, MD

Principal Investigator

Tufts Medical Center

Eligibility Criteria

This trial is for patients with pulmonary arterial hypertension who have previously participated in LIQ861 studies. They must understand the study, follow its procedures, and agree to use contraception if there's a risk of pregnancy. Participants should have completed prior LIQ861 study requirements or reached an endpoint.

Inclusion Criteria

Evidence of a personally signed and dated informed consent document exists indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures

Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Patient has fulfilled all entry criteria at the time of enrollment in original study with LIQ861

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Exclusion Criteria

Patient prematurely discontinued LIQ861 due to a drug-related AE/SAE or tolerability issue in the original LIQ861 study in which they were enrolled, or patient did not complete protocol defined study procedures at an end of study visit (not Early Termination visit) in their original LIQ861 study

Patient withdrew consent during participation in another LIQ861 study

Any reason exists that, in the opinion of the Investigator or Medical Monitor, precludes the patient from participating in the study, e.g., any previous or intercurrent medical condition that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation.

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Treatment Details

Interventions

LIQ861 Inhaled Treprostinil (Prostacyclin Analogue)

Trial OverviewThe focus of this extension study is on the long-term safety of inhaling a drug called Treprostinil (LIQ861) as a dry powder for treating pulmonary arterial hypertension. It continues from previous LIQ861 trials.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: LIQ861 Inhaled TreprostinilExperimental Treatment1 Intervention

LIQ861 inhaled treprostinil at capsule strengths of 25 μg, 50 μg, 75 μg and 100 μg. LIQ861 will be administered using the RS00 Model 8 dry powder inhalation (DPI) device (Plastiape S.p.A.; Osnago, Italy) at dose levels of 25 μg capsule strength to 200 μg capsule strength treprostinil four times a day (QID) in individual patients. Titrating to dose levels beyond 200 μg capsule strength QID, under clinical investigator supervision, requires review and approval from the Medical Monitor.