ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00705133
Recruitment Status : Completed
First Posted : June 25, 2008
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
United Therapeutics
Information provided by (Responsible Party):
Rajan Saggar, University of California, Los Angeles

June 23, 2008
June 25, 2008
March 6, 2018
July 2008
January 2011   (Final data collection date for primary outcome measure)
6 minute walk distance [ Time Frame: 3 months ]
ATS Practice Guideline based 6MW distance
6 minute walk distance [ Time Frame: 3 months ]
Complete list of historical versions of study NCT00705133 on ClinicalTrials.gov Archive Site
  • pulmonary hemodynamics [ Time Frame: 3 months ]
    repeat right heart catheterization
  • Quality of life and shortness of breath indices [ Time Frame: 3 months ]
    SF-36 and SGRQ
  • brain natriuretic peptide [ Time Frame: 3 months ]
    BNP
  • Hemodynamic parameters [ Time Frame: 3 months ]
  • Quality of life and shortness of breath indices [ Time Frame: 3 months ]
Not Provided
Not Provided
 
Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension
Using Either Intravenous (IV) or Subcutaneous (SQ) Treprostinil to Treat Pulmonary Hypertension Related to Underlying Interstitial Lung Disease
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.
Patients with pulmonary hypertension complicating pulmonary fibrosis are at increased risk of death. There are no therapies proven to be effective in this population, targeting the pulmonary hypertension. The purpose of this study is to evaluate parenteral treprostinil in an open-label fashion in patients with pulmonary fibrosis and an advanced PH phenotype.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pulmonary Arterial Hypertension
  • Interstitial Lung Disease
  • Idiopathic Pulmonary Fibrosis
Drug: Treprostinil
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
Other Name: remodulin
Experimental: Treprostinil-treated
Patients with pulmonary fibrosis with an advanced pulmonary hypertension phenotype will be treated with parenteral treprostinil in an open-label fashion
Intervention: Drug: Treprostinil
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
20
April 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Eligible subjects must have IPF and severe 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.
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00705133
07-11-087-01
No
Not Provided
Plan to Share IPD: No
Rajan Saggar, University of California, Los Angeles
Rajan Saggar
United Therapeutics
Principal Investigator: Rajan Saggar, MD David Geffen School of Medicine, UCLA
Principal Investigator: David Zisman, MD David Geffen School of Medicine, UCLA
University of California, Los Angeles
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP