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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
United Therapeutics
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00705133
First received: June 23, 2008
Last updated: June 24, 2008
Last verified: June 2008

June 23, 2008
June 24, 2008
January 2008
October 2008   (final data collection date for primary outcome measure)
6 minute walk distance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00705133 on ClinicalTrials.gov Archive Site
  • Hemodynamic parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Quality of life and shortness of breath indices [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 per day initially as tolerated and then increased by 0.5ng/kg/min every 2 days as an outpatient. The maximum dose at 3 months will be 40ng/kg/min
Experimental: I
Patients with idiopathic pulmonary fibrosis with severe pulmonary arterial hypertension
Intervention: Drug: treprostinil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
February 2009
October 2008   (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.
Both
Not Provided
No
Contact: Rajan Saggar, MD 310-825-5635 rsaggar@mednet.ucla.edu
Contact: Paul Lopez, RN plopez@mednet.ucla.edu
United States
 
NCT00705133
07-11-087-01
No
Rajan Saggar MD, David Geffen School of Medicine, University of California, Los Angeles
University of California, Los Angeles
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
June 2008

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