Pulmonary HypertensionPhase 2NCT02603068
Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
A Phase 2 study testing Oral treprostinil in people with Pulmonary Hypertension and Pulmonary Fibrosis, run by United Therapeutics at 7 sites in United States.
Trial summary
This multicenter, randomized, open-label study will assess the safety and efficacy of oral treprostinil in subjects diagnosed with pulmonary hypertension associated with pulmonary fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Fibrosis
- What is being tested?
- Oral treprostinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2016to Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily gives informed consent
- Must meet criteria for lung transplant referral but is not required to be on an active lung transplant list
- Stable and significant diffuse parenchymal lung disease with a diagnosis of interstitial lung disease
- 6MWD greater than or equal to 75 meters
- Right heart catheterization with a mean pulmonary arterial pressure >= 30 mgHg, pulmonary capillary wedge pressure <= 15 mmHg and pulmonary vascular resistance > 240 dynes
- Echo-Doppler examination showing evidence of right ventricular dysfunction and normal left diastolic ventricular function
- Either not receiving any PAH-approved oral therapy, or is receiving monotherapy (ERA, PDE-5I, or riociguat) for > 60 days and receiving a stable dose for > 30 days prior to enrollment
- Able to communicate effectively with study personnel and will to be cooperative with protocol requirements
Who cannot join
- History of repaired or unrepaired congenital heart disease
- Received prostanoid therapy in the past 30 days, or has shown an intolerance or lack of efficacy to prostanoid therapy resulting in discontinuation or inability to titrate prostacyclins
- Diagnosis of sarcoidosis
- History of thromboembolic disease
- Chronic renal insufficiency
- Pregnancy or lactating
- Currently receiving an investigational drug, has an investigational device in place, or has participated in an investigational drug or device study within 30 days prior to Screening
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Emory University Hospital
Atlanta, Georgia, 30322
Johns Hopkins University
Baltiomore, Maryland, 21205
University of California, Los Angeles - Pulmonary Division
Los Angeles, California, 90024
Banner University Medical Center Phoenix Advanced Lung Disease
Phoenix, Arizona, 85006
CLC Pulmonary Hypertension Clinic Division of Pulmonary, Allergy and Critical Care Medicine UPMC
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University
Portland, Oregon, 97239
University of California - Davis Medical Group
Sacramento, California, 95817
About this study
Official title: Multicenter, Randomized, Open Label Trial to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
This multicenter, randomized, open-label study will assess the safety and efficacy of oral treprostinil in subjects diagnosed with pulmonary hypertension associated with pulmonary fibrosis.
Read the detailed description
This study will evaluate how oral treprostinil can affect pulmonary vascular resistance, as assessed by right heart catheterization, and exercise capacity, as assessed by the Six-Minute Walk Test. This is a 16-week study that will involve at least 10 clinical trial centers. The expected enrollment period is around 24 months and 52 subjects will be entered into the study.
- Conditions
- Pulmonary Hypertension, Pulmonary Fibrosis
- Being tested
- Oral treprostinil
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral treprostinilDrug
Also called Orenitram
Oral treprostinil will be administered as TID dosing for up to 16 Weeks.
| Study group | Role | What they receive |
|---|---|---|
| Individual Maximum Tolerated Dose (iMTD) | Experimental | Subjects are allowed to titrate oral treprostinil up to a maximum dose of 12 mg TID. Receives: Drug: Oral treprostinil |
| Fixed Dose (FD) | Experimental | Subjects are allowed to titrate oral treprostinil up to a maximum dose of 1 mg TID. Receives: Drug: Oral treprostinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulmonary vascular resistance (PVR)
Change in PVR between iMTD and fixed dose groups
Measured: Baseline to Week 16
Secondary outcomes (2)
Change in Six-minute walk distance (6MWD)
Change in 6MWD between iMTD and fixed dose groups
Measured: Baseline to Week 16
Change in N-terminal pro-brain natriuretic peptide (NT-ProBNP)
Change in NT-ProBNP between iMTD and fixed dose groups
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionApr 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: Study design was inadequate and would not achieve study endpoints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajan Saggar, MD, Principal investigator, University of California, Los Angeles - Pulmonary Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603068
- Sponsor's protocol ID
- TDE-PH-204
- Status last verified
- Feb 2016
- First submitted
- 10 Nov 2015
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Study is withdrawn. There is no data to share.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open Label Trial to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02603068
- Acronym / sponsor ID
- TDE-PH-204
- Conditions
- Pulmonary Hypertension, Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study design was inadequate and would not achieve study endpoints
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, open-label study will assess the safety and efficacy of oral treprostinil in subjects diagnosed with pulmonary hypertension associated with pulmonary fibrosis.
Detailed description
This study will evaluate how oral treprostinil can affect pulmonary vascular resistance, as assessed by right heart catheterization, and exercise capacity, as assessed by the Six-Minute Walk Test. This is a 16-week study that will involve at least 10 clinical trial centers. The expected enrollment period is around 24 months and 52 subjects will be entered into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Maximum Tolerated Dose (iMTD) | Experimental | Drug: Oral treprostinilSubjects are allowed to titrate oral treprostinil up to a maximum dose of 12 mg TID. |
| Fixed Dose (FD) | Experimental | Drug: Oral treprostinilSubjects are allowed to titrate oral treprostinil up to a maximum dose of 1 mg TID. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily gives informed consent
- Must meet criteria for lung transplant referral but is not required to be on an active lung transplant list
- Stable and significant diffuse parenchymal lung disease with a diagnosis of interstitial lung disease
- 6MWD greater than or equal to 75 meters
- Right heart catheterization with a mean pulmonary arterial pressure >= 30 mgHg, pulmonary capillary wedge pressure <= 15 mmHg and pulmonary vascular resistance > 240 dynes
Key exclusion criteria (7 listed)
- History of repaired or unrepaired congenital heart disease
- Received prostanoid therapy in the past 30 days, or has shown an intolerance or lack of efficacy to prostanoid therapy resulting in discontinuation or inability to titrate prostacyclins
- Diagnosis of sarcoidosis
- History of thromboembolic disease
- Chronic renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral treprostinilAlso: OrenitramOral treprostinil will be administered as TID dosing for up to 16 Weeks. | Drug | Fixed Dose (FD), Individual Maximum Tolerated Dose (iMTD) |
Primary outcome
Change in pulmonary vascular resistance (PVR)
Time frame: Baseline to Week 16
Change in PVR between iMTD and fixed dose groups
2 secondary outcomes
Change in Six-minute walk distance (6MWD)
Time frame: Baseline to Week 16
Change in N-terminal pro-brain natriuretic peptide (NT-ProBNP)
Time frame: Baseline to Week 16
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Individual participant dataSharing planned: No. Study is withdrawn. There is no data to share.
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
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Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajan Saggar, MD principal investigator
University of California, Los Angeles - Pulmonary Division
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral treprostinil in people with Pulmonary Hypertension and Pulmonary Fibrosis, run by United Therapeutics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pulmonary vascular resistance (PVR) (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.