Condition or disease | Intervention/treatment | Phase |
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Pulmonary Arterial Hypertension | Drug: Treprostinil Inhalation Powder | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Single-sequence in which subjects on a stable regimen of Tyvaso will switch to a corresponding dose of TreT |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects With Pulmonary Arterial Hypertension Currently Using Tyvaso |
Actual Study Start Date : | September 17, 2019 |
Estimated Primary Completion Date : | March 2022 |
Estimated Study Completion Date : | March 2022 |
Arm | Intervention/treatment |
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Experimental: Tyvaso to TreT
Each subject will receive a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
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Drug: Treprostinil Inhalation Powder
Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
Other Name: TreT
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Women of childbearing potential are those who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal (defined as amenorrhea for at least 12 consecutive months). WOCBP must be nonpregnant (as confirmed by a urine pregnancy test at Screening prior to initiating study medication), nonlactating, and will do 1 of the following:
Subject is diagnosed with PAH as defined by the following World Health Organization (WHO) Group 1 categories:
Exclusion Criteria:
Tracking Information | |||||
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First Submitted Date ICMJE | May 9, 2019 | ||||
First Posted Date ICMJE | May 15, 2019 | ||||
Last Update Posted Date | March 30, 2021 | ||||
Actual Study Start Date ICMJE | September 17, 2019 | ||||
Estimated Primary Completion Date | March 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of subjects with treatment-emergent adverse events [Safety and Tolerability] [ Time Frame: 3 weeks ] The safety and tolerability of TreT in subjects with PAH currently treated with Tyvaso will be evaluated by the number of subjects with treatment-emergent adverse events
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso | ||||
Official Title ICMJE | An Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects With Pulmonary Arterial Hypertension Currently Using Tyvaso | ||||
Brief Summary | This is a Phase 1b safety and tolerability single-sequence study in which PAH subjects on a stable regimen of Tyvaso will switch to a corresponding dose of TreT. | ||||
Detailed Description | United Therapeutics Corporation (UTC) is developing a combination drug-device product which is comprised of a dry powder formulation of Treprostinil Inhalation Powder (TreT) and a small, portable, dry powder inhaler. In this Phase 1b safety and tolerability study, patients with PAH on a stable dose of Tyvaso (6 to 12 breaths 4 times daily [QID]) will be evaluated after switching to a corresponding dose of TreT. Patients will undergo PK assessments, safety assessments, a 6-Minute Walk Test (6MWT), and questionnaires for satisfaction/preference for inhaled devices and patient-reported PAH symptoms and impact. Following 3 weeks of treatment with TreT, patients will be offered the opportunity to participate in the Optional Extension Phase until the study terminates or the drug/device becomes commercially available. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single-sequence in which subjects on a stable regimen of Tyvaso will switch to a corresponding dose of TreT Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Pulmonary Arterial Hypertension | ||||
Intervention ICMJE | Drug: Treprostinil Inhalation Powder
Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
Other Name: TreT
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Study Arms ICMJE | Experimental: Tyvaso to TreT
Each subject will receive a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Intervention: Drug: Treprostinil Inhalation Powder
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
51 | ||||
Original Estimated Enrollment ICMJE |
45 | ||||
Estimated Study Completion Date ICMJE | March 2022 | ||||
Estimated Primary Completion Date | March 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03950739 | ||||
Other Study ID Numbers ICMJE | TIP-PH-101 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | United Therapeutics | ||||
Study Sponsor ICMJE | United Therapeutics | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | United Therapeutics | ||||
Verification Date | March 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |