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Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan

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ClinicalTrials.gov Identifier: NCT00625469
Recruitment Status : Withdrawn (competing studies did not allow enrollment)
First Posted : February 28, 2008
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Rajan Saggar, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE February 19, 2008
First Posted Date  ICMJE February 28, 2008
Last Update Posted Date March 6, 2018
Actual Study Start Date  ICMJE October 2007
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
6 minute walk distance [ Time Frame: monthly assessement until date of lung transplantation ]
ATS Guideline 6MW distance before and after intervention
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
6 minute walk distance [ Time Frame: monthly assessement until date of lung transplantation ]
Change History Complete list of historical versions of study NCT00625469 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
  • right heart catheterization hemodynamics [ Time Frame: variable based on time between listing and actual lung transplantation ]
    pulmonary hemodynamics
  • chemokine peripheral blood analysis [ Time Frame: monthly ]
    battery of chemokines analyzed from the peripheral blood
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
  • right heart catheterization hemodynamics [ Time Frame: variable based on time between listing and actual lung transplantation ]
  • chemokine peripheral blood analysis [ Time Frame: monthly ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan
Official Title  ICMJE Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study
Brief Summary Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that bosentan may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.
Detailed Description The purpose of this study was to evaluate bosentan in the setting of exercise or resting pulmonary hypertension in patients with underlying pulmonary fibrosis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Arterial Hypertension
  • Idiopathic Pulmonary Fibrosis
Intervention  ICMJE Drug: bosentan
62.5mg orally bid for first month, followed by 125mg bid thereafter
Other Name: tracleer
Study Arms  ICMJE
  • Experimental: treatment with bosentan
    patients with resting or exercise induced PAH receive bosentan in a randomized open label fashion
    Intervention: Drug: bosentan
  • No Intervention: PAH group with no therapy
    patients with resting or exercise PAH get randomized to receive no specific therapy
  • No Intervention: No PAH and no therapy
    patients with no evidence of either resting or exercise PAH receive no intervention but are followed until lung transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 2, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2008)
50
Estimated Study Completion Date  ICMJE December 2009
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Idiopathic Pulmonary Fibrosis referred for lung transplantation
  • Minimum 50 meter 6 minute walk distance
  • No significant underlying liver disease

Exclusion Criteria:

  • Significant liver disease or cirrhosis
  • non ambulatory
  • previous adverse reaction/allergy to Bosentan
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00625469
Other Study ID Numbers  ICMJE IPF/PAH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rajan Saggar, University of California, Los Angeles
Study Sponsor  ICMJE Rajan Saggar
Collaborators  ICMJE Actelion
Investigators  ICMJE
Principal Investigator: Rajan Saggar, MD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date March 2018

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