Pulmonary HypertensionNCT05572996
Inhaled Treprostinil Expanded Access Program in Pulmonary Hypertension Associated With Interstitial Lung Disease
A study testing Inhaled Treprostinil in people with Pulmonary Hypertension and Interstitial Lung Disease, run by Ferrer Internacional S.A..
Trial summary
This is an Expanded Access Program (EAP) for eligible participants with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) designed to provide access to Inhaled Treprostinil. Availability will depend on territory elegibility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Interstitial Lung Disease, Combined Pulmonary Fibrosis and Emphysema
- What is being tested?
- Inhaled Treprostinil
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patient consent
- Males and females aged 18 years old or older
- PH-ILD diagnosis:
- Confirmed diagnosis of Group 3 PH by Right Heart Catheterization (RHC):
- mPAP > 20 mmHg with PAWP ≤ 15 mmHg and PVR ≥ 2 WU and
- Confirmed diagnosis of diffuse parenchymal lung disease based on imaging (any form of ILD or CPFE)
Who cannot join
- Diagnosis of PAH or PH for reasons other than Group 3 PH-ILD
- Use of concomitant PAH drugs contraindicated for PH-ILD (ambrisentan and riociguat)
- Use of any concomitant investigational drug
Trial locations and contacts
No sites are listed yet.
About this study
This is an Expanded Access Program (EAP) for eligible participants with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) designed to provide access to Inhaled Treprostinil. Availability will depend on territory elegibility.
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease, Combined Pulmonary Fibrosis and Emphysema
- Being tested
- Inhaled Treprostinil
- Keywords
- Inhaled Treprostinil, Tyvaso, EAP, Expanded Access, Early Access, Compassionate Use, Named Patient Program, NPP, PH-ILD
- Medical subject headings
- Hypertension, Pulmonary, Lung Diseases, Interstitial, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled TreprostinilDrug
Also called Tyvaso
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
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.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Ferrer Internacional S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572996
- Sponsor's protocol ID
- FITREP-EAP2201
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Treprostinil Expanded Access Program in Pulmonary Hypertension Associated With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT05572996
- Acronym / sponsor ID
- FITREP-EAP2201
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease, Combined Pulmonary Fibrosis and Emphysema
- Keywords
- Inhaled Treprostinil, Tyvaso, EAP, Expanded Access, Early Access, Compassionate Use, Named Patient Program, NPP
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Ferrer Internacional S.A.Industry (pharma, biotech, devices)
- First posted
- 10 Oct 2022 (actual)
- 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 is an Expanded Access Program (EAP) for eligible participants with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) designed to provide access to Inhaled Treprostinil. Availability will depend on territory elegibility.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient consent
- Males and females aged 18 years old or older
- PH-ILD diagnosis:
Key exclusion criteria (3 listed)
- Diagnosis of PAH or PH for reasons other than Group 3 PH-ILD
- Use of concomitant PAH drugs contraindicated for PH-ILD (ambrisentan and riociguat)
- Use of any concomitant investigational drug
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 |
|---|---|---|
| Inhaled TreprostinilAlso: Tyvaso | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaled Treprostinil in people with Pulmonary Hypertension and Interstitial Lung Disease, run by Ferrer Internacional S.A..
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ferrer Medical Information (+34 629 966 806, medinfo@ferrer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 10 Oct 2022.