Trial Outcomes & Findings for TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH) (NCT NCT03055221)
NCT ID: NCT03055221
Last Updated: 2024-01-05
Results Overview
The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
Results posted on
2024-01-05
Participant Flow
Participant milestones
| Measure |
Intravenous Treprostinil
Intravenous treprostinil was supplied as 1 mg/mL.
Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Intravenous Treprostinil
Intravenous treprostinil was supplied as 1 mg/mL.
Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
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|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Death
|
6
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Study terminated by Sponsor
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
Baseline characteristics by cohort
| Measure |
Intravenous Treprostinil
n=16 Participants
Intravenous treprostinil was supplied as 1 mg/mL.
Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
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|---|---|
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Age, Continuous
|
30.1 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
India
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16 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visitPopulation: Data are presented for subjects who completed the 6MWT at their final visit. Not all subjects completed a 6MWT at their final visit.
The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
Outcome measures
| Measure |
Intravenous Treprostinil
n=13 Participants
Intravenous treprostinil was supplied as 1 mg/mL.
Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
|
|---|---|
|
Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)
|
440.8 Meters
Standard Deviation 108.6
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PRIMARY outcome
Timeframe: The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visitPopulation: 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.
The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).
Outcome measures
| Measure |
Intravenous Treprostinil
n=11 Participants
Intravenous treprostinil was supplied as 1 mg/mL.
Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
|
|---|---|
|
Effect of Long-term Remodulin Therapy on the NYHA Functional Classification
|
2.1 Functional Class
Standard Deviation 0.6
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PRIMARY outcome
Timeframe: Baseline to Week 12Population: Intent-to-Treat Population
Safety was assessed by summarizing the number of subjects with at least 1 AE during the 12 weeks (or until premature termination).
Outcome measures
| Measure |
Intravenous Treprostinil
n=16 Participants
Intravenous treprostinil was supplied as 1 mg/mL.
Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
|
|---|---|
|
Effect of Long-term Remodulin Therapy on Subject Safety
|
14 Participants
|
Adverse Events
Intravenous Treprostinil
Serious events: 14 serious events
Other events: 14 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Intravenous Treprostinil
n=16 participants at risk
Intravenous treprostinil was supplied as 1 mg/mL.
Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
|
|---|---|
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Infections and infestations
Bacteraemia
|
12.5%
2/16 • Number of events 2 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Pyrexia
|
31.2%
5/16 • Number of events 5 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Infections and infestations
Sepsis
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Cardiac disorders
Cardiac failure acute
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Cardiac disorders
Cardiac failure congestive
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Cardiac disorders
Right ventricular failure
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Catheter site swelling
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Chills
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Device dislocation
|
18.8%
3/16 • Number of events 5 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Disease progression
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Infusion site pain
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Hepatobiliary disorders
Hepatomegaly
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Infections and infestations
Atypical pneumonia
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Infections and infestations
Catheter site infection
|
25.0%
4/16 • Number of events 5 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Infections and infestations
Device-related infection
|
18.8%
3/16 • Number of events 3 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Infections and infestations
Device-related sepsis
|
12.5%
2/16 • Number of events 2 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Infections and infestations
Endocarditis
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Infections and infestations
Localized infection
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Infections and infestations
Lower respiratory tract infection
|
6.2%
1/16 • Number of events 2 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Infections and infestations
Septic shock
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Reproductive system and breast disorders
Polymenorrhea
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
6.2%
1/16 • Number of events 2 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Surgical and medical procedures
Abortion induced
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Vascular disorders
Thrombophlebitis
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Vascular disorders
Venous thrombosis
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
Other adverse events
| Measure |
Intravenous Treprostinil
n=16 participants at risk
Intravenous treprostinil was supplied as 1 mg/mL.
Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
|
|---|---|
|
Cardiac disorders
Cyanosis
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Eye disorders
Lacrimation increased
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
18.8%
3/16 • Number of events 3 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
2/16 • Number of events 5 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Gastrointestinal disorders
Nausea
|
18.8%
3/16 • Number of events 3 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Local swelling
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Oedema
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Pain
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Pyrexia
|
6.2%
1/16 • Number of events 3 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Catheter site pain
|
18.8%
3/16 • Number of events 5 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Infections and infestations
Wound infection
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Investigations
Weight decreased
|
6.2%
1/16 • Number of events 2 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
2/16 • Number of events 5 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
12.5%
2/16 • Number of events 2 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 3 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Reproductive system and breast disorders
Gynacomastia
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • Number of events 5 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16 • Number of events 2 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
2/16 • Number of events 2 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Cardiac disorders
Right ventricular failure
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Chills
|
6.2%
1/16 • Number of events 3 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Device dislocation
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Catheter site swelling
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
General disorders
Chest pain
|
6.2%
1/16 • Number of events 2 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Renal and urinary disorders
Haematuria
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
1/16 • Number of events 1 • Baseline to each subject's last visit, assessed up to approximately 9 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and/or Principal Investigator agree not to publish or publicly present any interim results of the Study without the prior written consent of Sponsor, not to be unreasonably withheld or delayed. Institution and/or Principal Investigator further agree to provide Sponsor with drafts of any such publication or presentation for review and approval no less than 30 days prior to submission for publication or the date of public presentation.
- Publication restrictions are in place
Restriction type: OTHER