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

NCT00705133 | Completed Phase 2 Results

• 1 other identifier: 07-11-087-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Our hypothesis is that IV or SQ Treprostinil can improve 6 minute walk distance, hemodynamics and quality of life in patients with interstitial lung disease and severe secondary pulmonary arterial hypertension.

Conditions

Pulmonary Arterial Hypertension; Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis

Keywords

pulmonary hypertension; pulmonary fibrosis; interstitial lung disease

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Distance

  American Thoracic Society (ATS) Practice Guideline based 6-minute walk (6MW) distance

  3 months

Secondary Outcomes (3)

• Pulmonary Vascular Resistance

  3 months

• SF-36 Quality of Life

  3 months

• Brain Natriuretic Peptide

  3 months

Study Arms (1)

Treprostinil-treated

EXPERIMENTAL

Patients with pulmonary fibrosis with an advanced pulmonary hypertension phenotype will be treated with parenteral treprostinil in an open-label fashion

Drug: Treprostinil

Interventions

Treprostinil DRUG

For both SQ and IV routes, treprostinil will be started in the hospital at 1ng/kg/min and titrated up by 1ng/kg/min every 1-3 days as tolerated

Also known as: remodulin

Treprostinil-treated

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).
• Six-minute walk distance (6MWD) \< 50 meters at screening or baseline standard of care evaluations
• Standard of care pulmonary function test (PFT) showing forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio \< 0.65
• Standard of care pulmonary function test (PFT) showing a residual volume \>120% predicted
• Standard of care high-resolution chest computed tomography (HRCT) showing emphysema extent \> 30%
• Any investigational therapy as part of a clinical trial for any indication with 30 days before screening
• 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.
• Current treatment for pulmonary hypertension with other prostaglandins (epoprostenol or iloprost)
• 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
• Pulmonary rehabilitation initiated within 30 days of baseline.

Sponsors & Collaborators

• Rajan Saggar: lead
• United Therapeutics: collaborator

Study Sites (1)

David Geffen School of Medicine, UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Saggar R, Khanna D, Vaidya A, Derhovanessian A, Maranian P, Duffy E, Belperio JA, Weigt SS, Dua S, Shapiro SS, Goldin JG, Abtin F, Lynch JP 3rd, Ross DJ, Forfia PR, Saggar R. Changes in right heart haemodynamics and echocardiographic function in an advanced phenotype of pulmonary hypertension and right heart dysfunction associated with pulmonary fibrosis. Thorax. 2014 Feb;69(2):123-9. doi: 10.1136/thoraxjnl-2013-204150.

  PMID: 24431095 RESULT

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis; Hypertension, Pulmonary; Pulmonary Fibrosis

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Rajan Saggar
• Organization: UC Los Angeles

rsaggar@mednet.ucla.edu

310-206-6766

Study Officials

• Rajan Saggar, MD

  David Geffen School of Medicine, UCLA

  PRINCIPAL INVESTIGATOR

• David Zisman, MD

  David Geffen School of Medicine, UCLA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 25, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 9, 2020
• Results First Posted: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)