Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension - Full Text View

Sponsors and Collaborators:	University of California, Los Angeles United Therapeutics
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00705133

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 III

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Fibrosis Pulmonary Hypertension

Drug Information available for: U 62840

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Using Either Intravenous (IV) or Subcutaneous (SQ) Treprostinil to Treat Pulmonary Hypertension Related to Underlying Interstitial Lung Disease

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
I: Experimental 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.

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.

Exclusion Criteria:

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.

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

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

Keywords provided by University of California, Los Angeles:

pulmonary hypertension
pulmonary fibrosis
interstitial lung disease

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Lung Diseases, Interstitial
Respiratory Tract Diseases
Fibrosis
Hypertension, Pulmonary
Hamman-Rich syndrome

Lung Diseases
Treprostinil
Vascular Diseases
Pulmonary Fibrosis
Hypertension

Additional relevant MeSH terms:

Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009