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Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of Treprostinil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03992755
Recruitment Status : Active, not recruiting
First Posted : June 20, 2019
Last Update Posted : April 15, 2020
Sponsor:
Collaborator:
Nuventra, Inc.
Information provided by (Responsible Party):
Liquidia Technologies, Inc.

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

Condition or disease Intervention/treatment Phase
Primary Pulmonary Hypertension Drug: LIQ861 Inhaled Treprostinil Phase 3

Detailed Description:
One of the greatest impediments to patient treatment satisfaction with current inhaled treprostinil therapy is inconvenience. Currently, PAH patients using inhaled treprostinil may require more than 36 breaths per day using a nebulizer requiring daily set up and cleaning. The use of a discrete, hand-held dry powder inhaler to deliver treprostinil to the lungs could represent a major improvement in convenience and patient satisfaction, thereby improving the quality of life for PAH patients. Liquidia is pursuing approval of LIQ861, an inhalation dry powder formulation of treprostinil that is produced using Liquidia's PRINT® Technology (Particle Replication in Nonwetting Templates), as an alternative to current inhaled treprostinil therapy for the treatment of patients with PAH (WHO Group 1).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The study will evaluate the long-term safety of LIQ861 in PAH (WHO Group 1) patients who have completed a Liquidia LIQ861 clinical study. All patients will be treated on an outpatient basis until regulatory approval of LIQ861 or study is terminated by sponsor. Study enrollment will occur after final assessments from a prior study have been completed.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Global, Open-Label Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients
Actual Study Start Date : July 18, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 30, 2022


Arm Intervention/treatment
Experimental: LIQ861 Inhaled Treprostinil
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.
Drug: LIQ861 Inhaled Treprostinil
LIQ861 bulk powder is generated from a treprostinil/excipient matrix from which particles of precise size and shape are created and filled into a hydroxypropyl methylcellulose (HPMC) capsule (size 3). LIQ861 capsules are provided in capsule strengths of 25 μg, 50 μg, 75 μg and 100 μg treprostinil.
Other Names:
  • Inhaled treprostinil
  • Inhaled prostacyclin




Primary Outcome Measures :
  1. Number of participants with treatment emergent adverse events (AEs). [ Time Frame: Baseline until the end of study, approximately 2.5 years (Dec-2021). ]
    Treatment-emergent adverse events and serious adverse events will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  3. Patient has fulfilled all entry criteria at the time of enrollment in original study with LIQ861.
  4. Patient has completed the protocol defined end of study procedures or met a protocol-defined and adjudicated endpoint in the original LIQ861 study in which they were enrolled.
  5. Patient, whether male or female, agrees to use a medically acceptable method of contraception throughout the entire study period from informed consent through the termination visit, if the possibility of conception exists. Eligible male and female patients must also agree not to participate in a conception process (e.g., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of LIQ861.

Exclusion Criteria:

  1. 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.
  2. Patient withdrew consent during participation in another LIQ861 study.
  3. Patient is a female who wishes to become pregnant or who has a positive pregnancy test on Day 1 (LTI-302 Study Initiation Visit).
  4. Patient has undergone lung or heart/lung transplant or the initiation of parenteral (intravenous [IV] infusion or subcutaneous injection) therapy with a prostacyclin during the time since participation in their original LIQ861 study.
  5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992755


Locations
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Sponsors and Collaborators
Liquidia Technologies, Inc.
Nuventra, Inc.
Investigators
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Principal Investigator: Nicholas S Hill, MD Tufts Medical Center
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Responsible Party: Liquidia Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03992755    
Other Study ID Numbers: LTI-302
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liquidia Technologies, Inc.:
Pulmonary Arterial Hypertension
Idiopathic Pulmonary Arterial Hypertension
Heritable Pulmonary Arterial Hypertension
Drug Induced Pulmonary Arterial Hypertension
Toxin Induced Pulmonary Arterial Hypertension
Connective tissue disease
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents