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Sponsors and Collaborators: |
University of California, Los Angeles United Therapeutics |
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Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00705133 |
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 |
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Pulmonary Arterial Hypertension Interstitial Lung Disease Idiopathic Pulmonary Fibrosis |
Drug: treprostinil |
Phase III |
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 |
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 |
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I: Experimental
Patients with idiopathic pulmonary fibrosis with severe pulmonary arterial hypertension
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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
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Exclusion Criteria:
Contact: Rajan Saggar, MD | 310-825-5635 | rsaggar@mednet.ucla.edu |
Contact: Paul Lopez, RN | plopez@mednet.ucla.edu |
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 |
Principal Investigator: | Rajan Saggar, MD | David Geffen School of Medicine, UCLA |
Principal Investigator: | David Zisman, MD | David Geffen School of Medicine, UCLA |
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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
pulmonary hypertension pulmonary fibrosis interstitial lung disease |
Lung Diseases, Interstitial Fibrosis Vascular Diseases Treprostinil Cardiovascular Agents Antihypertensive Agents Pulmonary Fibrosis |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Hypertension Hypertension |
Lung Diseases, Interstitial Fibrosis Vascular Diseases Treprostinil Cardiovascular Agents Antihypertensive Agents Pulmonary Fibrosis Pharmacologic Actions |
Pathologic Processes Respiratory Tract Diseases Hypertension, Pulmonary Therapeutic Uses Lung Diseases Cardiovascular Diseases Hypertension |