Pulmonary Arterial HypertensionPhase 4TRUST-2NCT03055221

TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)

A Phase 4 study testing Intravenous Treprostinil in people with Pulmonary Arterial Hypertension, run by United Therapeutics.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study RIV-PH-402 were eligible to enroll. Read more about this study

Who is it for?: Ages 16 to 75 years
Conditions the study is for: Pulmonary Arterial Hypertension
What is being tested?: Intravenous Treprostinil
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: 10 Jun 2005to 25 Feb 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subjects who were enrolled in and completed Study RIV-PH-402 (TRUST-1)

Who cannot join

Subjects who were unblinded for potential rescue therapy in Study RIV-PH-402 and were found to be allocated to the Remodulin treatment group were not eligible to participate in this study.

About this study

Official title: TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)

Conditions: Pulmonary Arterial Hypertension
Being tested: Intravenous Treprostinil
Keywords: Remodulin, 6-Minute Walk Test
Medical subject headings: Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravenous TreprostinilDrug
Also called Remodulin
Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.

Study groups in NCT03055221
Study group	Role	What they receive
Intravenous Treprostinil	Experimental	Intravenous treprostinil was supplied as 1 mg/mL. Receives: Drug: Intravenous Treprostinil

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)
The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
Measured: The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
Effect of Long-term Remodulin Therapy on the NYHA Functional Classification
The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).
Measured: The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
Effect of Long-term Remodulin Therapy on Subject Safety
Safety was assessed by summarizing the number of subjects with at least 1 AE during the 12 weeks (or until premature termination).
Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 200525 Feb 2014

First posted16 Feb 2017
Study start10 Jun 2005
Primary completion25 Feb 2014
Study completion25 Feb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Arterial 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03055221
Sponsor's protocol ID: RIV-PH-403
Acronym: TRUST-2
Status last verified: Jun 2017
First submitted: 9 Feb 2017
Last updated: 5 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH

All Pulmonary Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
ClinicalTrials.gov ID: NCT03055221
Acronym / sponsor ID: TRUST-2 / RIV-PH-403
Conditions: Pulmonary Arterial Hypertension
Keywords: Remodulin, 6-Minute Walk Test
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: United TherapeuticsIndustry (pharma, biotech, devices)
Study start: 10 Jun 2005 (actual)
Primary completion: 25 Feb 2014 (actual)
Study completion: 25 Feb 2014 (actual)
First posted: 16 Feb 2017 (actual)
Results: Posted 28 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intravenous Treprostinil	Experimental	Drug: Intravenous TreprostinilIntravenous treprostinil was supplied as 1 mg/mL.

Who may qualify

Ages: 16 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Subjects who were enrolled in and completed Study RIV-PH-402 (TRUST-1)

Key exclusion criteria (1 listed)

Subjects who were unblinded for potential rescue therapy in Study RIV-PH-402 and were found to be allocated to the Remodulin treatment group were not eligible to participate in this study.

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
Intravenous TreprostinilAlso: RemodulinIntravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.	Drug	Intravenous Treprostinil

Primary outcome

Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)
Time frame: The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
Effect of Long-term Remodulin Therapy on the NYHA Functional Classification
Time frame: The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).
Effect of Long-term Remodulin Therapy on Subject Safety
Time frame: Baseline to Week 12
Safety was assessed by summarizing the number of subjects with at least 1 AE during the 12 weeks (or until premature termination).

Results and safety

Results posted to the registry on 28 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intravenous Treprostinil	20	0

Primary outcome: Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)

Time frame: The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit. Mean (Standard Deviation). Unit: Meters

Measure	Intravenous Treprostinil n = 13
Value	440.8 (108.6)

Population analysed: Data are presented for subjects who completed the 6MWT at their final visit. Not all subjects completed a 6MWT at their final visit.

Primary outcome: Effect of Long-term Remodulin Therapy on the NYHA Functional Classification

Time frame: The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit. Mean (Standard Deviation). Unit: Functional Class

Measure	Intravenous Treprostinil n = 11
Value	2.1 (0.6)

Population analysed: Data presented include all subjects who underwent an NYHA functional classification assessment at their final visit. Not all subjects underwent an NYHA assessement at their final visit.

Primary outcome: Effect of Long-term Remodulin Therapy on Subject Safety

Time frame: Baseline to Week 12. Count of participants. Unit: Participants

Measure	Intravenous Treprostinil n = 16
Value	14

Population analysed: Intent-to-Treat Population

Adverse events

Time frame: Baseline to each subject's last visit, assessed up to approximately 9 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intravenous Treprostinil	14 of 16 (87.5%)	14 of 16 (87.5%)	6 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Pulmonary Arterial 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
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intravenous Treprostinil in people with Pulmonary Arterial Hypertension, run by United Therapeutics.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Jan 2024. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD) (time frame: The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03055221.

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 5 Jan 2024.