Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00705133
• Date of registration: 23/06/2008
• Prospective Registration: Yes
• Primary sponsor: Rajan Saggar
• Public title: Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension
• Scientific title: Using Either Intravenous (IV) or Subcutaneous (SQ) Treprostinil to Treat Pulmonary Hypertension Related to Underlying Interstitial Lung Disease
• Date of first enrolment: July 2008
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00705133
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Rajan Saggar, MD
• Affiliation: David Geffen School of Medicine, UCLA

• Name: David Zisman, MD
• Affiliation: David Geffen School of Medicine, UCLA

Key inclusion & exclusion criteria

Inclusion Criteria:

Eligible subjects must have IPF and severe pulmonary arterial hypertension (PAH) documented
on standard of care right-heart catheterization (RHC) and planned to receive therapy with
treprostinil as recommended by the treating physician.

1. All subjects must have high resolution CT scan (HRCT) diagnostic of IPF (performed as
part of standard of care evaluation) or if available, biopsy proven histological usual
interstitial pneumonia (UIP).

2. Severe pulmonary arterial hypertension defined as a resting mean pulmonary artery
pressure (mPAP) > 35 mm Hg; AND pulmonary vascular resistance (PVR) > 3 woods-units;
AND pulmonary capillary wedge pressure (PCWP) < 18 mm Hg by right-heart
catheterization (RHC) performed as part of standard of care evaluation.

3. All subjects must be planned to receive treprostinil therapy as recommended by their
treating physician.

Exclusion Criteria:

1. Acute or chronic impairment other than dyspnea (e.g. angina pectoris, intermittent
claudication) limiting the ability to perform standard of care six-minute walk tests
(6MWT).

2. Six-minute walk distance (6MWD) < 50 meters at screening or baseline standard of care
evaluations

3. Standard of care pulmonary function test (PFT) showing forced expiratory volume in one
second (FEV1)/ forced vital capacity (FVC) ratio < 0.65

4. Standard of care pulmonary function test (PFT) showing a residual volume >120%
predicted

5. Standard of care high-resolution chest computed tomography (HRCT) showing emphysema
extent > 30%

6. Any investigational therapy as part of a clinical trial for any indication with 30
days before screening

7. Change in dose of treatment for IPF - investigational agent (gamma interferon-1b,
pirfenidone, etanercept, and any other investigational agent intended to treat IPF),
corticosteroids, or cytotoxic agents, within 30 days before screening. That is,
subjects can be on any of these agents provided the dose is stable for at least 30
days prior to enrollment.

8. Current treatment for pulmonary hypertension with other prostaglandins (epoprostenol
or iloprost)

9. Change in dose of treatment for PAH - (bosentan, sitaxsentan, ambrisentan, tadalafil,
sildenafil, vardenafil, calcium channel blockers, nitrates, digitalis), within 30 days
before screening. That is, subjects can be on any of these agents provided the dose is
stable for at least 30 days prior to enrollment

10. Pulmonary rehabilitation initiated within 30 days of baseline.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Interstitial Lung Disease

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Treprostinil

Primary Outcome(s)

6 Minute Walk Distance [Time Frame: 3 months]

Secondary Outcome(s)

Brain Natriuretic Peptide [Time Frame: 3 months]

Pulmonary Vascular Resistance [Time Frame: 3 months]

SF-36 Quality of Life [Time Frame: 3 months]

Secondary ID(s)

07-11-087-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

United Therapeutics

Results

• Results available: Yes
• Date Posted: 09/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00705133