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

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ClinicalTrials.gov Identifier: NCT03055221
Recruitment Status : Completed
First Posted : February 16, 2017
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Arterial Hypertension
Intervention Drug: Intravenous Treprostinil
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intravenous Treprostinil
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 16
Completed 0
Not Completed 16
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             4
Death             6
Physician Decision             1
Study terminated by Sponsor             3
Arm/Group Title Intravenous Treprostinil
Hide Arm/Group Description

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 Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
30.1  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
9
  56.3%
Male
7
  43.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
16
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
16
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
India Number Analyzed 16 participants
16
 100.0%
1.Primary Outcome
Title Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)
Hide Description The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
Time Frame The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data are presented for subjects who completed the 6MWT at their final visit. Not all subjects completed a 6MWT at their final visit.
Arm/Group Title Intravenous Treprostinil
Hide Arm/Group Description:

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 Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: Meters
440.8  (108.6)
2.Primary Outcome
Title Effect of Long-term Remodulin Therapy on the NYHA Functional Classification
Hide Description The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).
Time Frame The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intravenous Treprostinil
Hide Arm/Group Description:

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 Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: Functional Class
2.1  (0.6)
Time Frame Baseline to each subject's last visit, assessed up to approximately 9 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravenous Treprostinil
Hide Arm/Group Description

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.

All-Cause Mortality
Intravenous Treprostinil
Affected / at Risk (%)
Total   6/16 (37.50%)    
Show Serious Adverse Events Hide Serious Adverse Events
Intravenous Treprostinil
Affected / at Risk (%) # Events
Total   14/16 (87.50%)    
Blood and lymphatic system disorders   
Coagulopathy * 1  1/16 (6.25%)  1
Cardiac disorders   
Cardiac failure acute * 1  1/16 (6.25%)  1
Cardiac failure congestive * 1  1/16 (6.25%)  1
Right ventricular failure * 1  1/16 (6.25%)  1
Ear and labyrinth disorders   
Vertigo * 1  1/16 (6.25%)  1
General disorders   
Pyrexia * 1  5/16 (31.25%)  5
Catheter site swelling * 1  1/16 (6.25%)  1
Chills * 1  1/16 (6.25%)  1
Device dislocation * 1  3/16 (18.75%)  5
Disease progression * 1  1/16 (6.25%)  1
Infusion site pain * 1  1/16 (6.25%)  1
Hepatobiliary disorders   
Hepatomegaly * 1  1/16 (6.25%)  1
Infections and infestations   
Bacteraemia * 1  2/16 (12.50%)  2
Sepsis * 1  1/16 (6.25%)  1
Atypical pneumonia * 1  1/16 (6.25%)  1
Catheter site infection * 1  4/16 (25.00%)  5
Device-related infection * 1  3/16 (18.75%)  3
Device-related sepsis * 1  2/16 (12.50%)  2
Endocarditis * 1  1/16 (6.25%)  1
Localized infection * 1  1/16 (6.25%)  1
Lower respiratory tract infection * 1  1/16 (6.25%)  2
Nasopharyngitis * 1  1/16 (6.25%)  1
Pneumonia * 1  1/16 (6.25%)  1
Septic shock * 1  1/16 (6.25%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Pyogenic granuloma * 1  1/16 (6.25%)  1
Reproductive system and breast disorders   
Polymenorrhea * 1  1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
Interstitial lung disease * 1  1/16 (6.25%)  1
Lung consolidation * 1  1/16 (6.25%)  1
Pleural effusion * 1  1/16 (6.25%)  1
Pleurisy * 1  1/16 (6.25%)  1
Pulmonary arterial hypertension * 1  1/16 (6.25%)  2
Pulmonary hypertension * 1  1/16 (6.25%)  1
Surgical and medical procedures   
Abortion induced * 1  1/16 (6.25%)  1
Vascular disorders   
Thrombophlebitis * 1  1/16 (6.25%)  1
Venous thrombosis * 1  1/16 (6.25%)  1
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intravenous Treprostinil
Affected / at Risk (%) # Events
Total   14/16 (87.50%)    
Cardiac disorders   
Cyanosis * 1  1/16 (6.25%)  1
Right ventricular failure * 1  1/16 (6.25%)  1
Eye disorders   
Lacrimation increased * 1  1/16 (6.25%)  1
Gastrointestinal disorders   
Abdominal discomfort * 1  3/16 (18.75%)  3
Diarrhoea * 1  2/16 (12.50%)  5
Nausea * 1  3/16 (18.75%)  3
Vomiting * 1  2/16 (12.50%)  2
General disorders   
Local swelling * 1  1/16 (6.25%)  1
Oedema * 1  1/16 (6.25%)  1
Pain * 1  1/16 (6.25%)  1
Pyrexia * 1  1/16 (6.25%)  3
Catheter site pain * 1  3/16 (18.75%)  5
Chills * 1  1/16 (6.25%)  3
Device dislocation * 1  1/16 (6.25%)  1
Catheter site swelling * 1  1/16 (6.25%)  1
Chest pain * 1  1/16 (6.25%)  2
Infections and infestations   
Wound infection * 1  1/16 (6.25%)  1
Injury, poisoning and procedural complications   
Wound haemorrhage * 1  1/16 (6.25%)  1
Investigations   
Weight decreased * 1  1/16 (6.25%)  2
Metabolism and nutrition disorders   
Decreased appetite * 1  1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders   
Muscle spasms * 1  1/16 (6.25%)  1
Pain in extremity * 1  2/16 (12.50%)  5
Pain in jaw * 1  2/16 (12.50%)  2
Musculoskeletal chest pain * 1  1/16 (6.25%)  1
Nervous system disorders   
Headache * 1  2/16 (12.50%)  3
Psychiatric disorders   
Insomnia * 1  1/16 (6.25%)  1
Renal and urinary disorders   
Haematuria * 1  1/16 (6.25%)  1
Reproductive system and breast disorders   
Gynacomastia * 1  1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/16 (18.75%)  5
Dyspnea * 1  2/16 (12.50%)  2
Epistaxis * 1  1/16 (6.25%)  1
Productive cough * 1  1/16 (6.25%)  1
Rhinorrhoea * 1  1/16 (6.25%)  1
Oropharyngeal pain * 1  2/16 (12.50%)  2
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Leigh Peterson, PhD
Organization: United Therapeutics, Corp.
Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT03055221     History of Changes
Other Study ID Numbers: RIV-PH-403
First Submitted: February 9, 2017
First Posted: February 16, 2017
Results First Submitted: March 20, 2017
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017