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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
 Drug: treprostinil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Using Either Intravenous (IV) or Subcutaneous (SQ) Treprostinil to Treat Pulmonary Hypertension Related to Underlying Interstitial Lung Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 6 minute walk distance [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: January 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Patients with idiopathic pulmonary fibrosis with severe pulmonary arterial hypertension
 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705133

Contacts
Contact: Rajan Saggar, MD 310-825-5635 rsaggar@mednet.ucla.edu
Contact: Paul Lopez, RN plopez@mednet.ucla.edu

Locations
United States, California
David Geffen School of Medicine, UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Paul Lopez, RN         plopez@mednet.ucla.edu    
Principal Investigator: Rajan Saggar, MD            
Principal Investigator: David Zisman, MD            
Sub-Investigator: Rajeev Saggar, MD            
Sub-Investigator: Shelley Shapiro, MD PhD            
Sponsors and Collaborators
University of California, Los Angeles
United Therapeutics
Investigators
Principal Investigator: Rajan Saggar, MD David Geffen School of Medicine, UCLA
Principal Investigator: David Zisman, MD David Geffen School of Medicine, UCLA
  More Information

No publications provided

Responsible Party: Rajan Saggar MD, David Geffen School of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00705133     History of Changes
Other Study ID Numbers: 07-11-087-01
Study First Received: June 23, 2008
Last Updated: June 24, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
pulmonary hypertension
pulmonary fibrosis
interstitial lung disease

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Pulmonary Fibrosis
Lung Diseases, Interstitial
Idiopathic Pulmonary Fibrosis
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Idiopathic Interstitial Pneumonias
 Fibrosis
Hypertension
Pathologic Processes
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013