Ignite Creation Date:
2024-05-05 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 9:41 AM
Study NCT ID:
NCT00593905
Status:
WITHDRAWN
Last Update Posted:
2021-12-09
First Post:
2008-01-03
Brief Title:
Pharmacogenomics in Pulmonary Arterial Hypertension
Sponsor:
West Penn Allegheny Health System
Organization:
West Penn Allegheny Health System
Study Overview
Official Title:
Pharmacogenomics in Pulmonary Arterial Hypertension A Multi-Center International Study to Determine Whether in PAH Patients Clinical Associations Exist Between the Efficacy and Toxicity of Endothelin Receptor Antagonists and Several Gene Polymorphisms in Several Key Disease-Specific and Therapy Specific Genes
Status:
WITHDRAWN
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study not started not an ACT
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our goal is to determine clinically in Pulmonary Arterial Hypertension patients if associations exist between the efficacy and toxicity of sitaxsentan bosentan and ambrisentan and several gene polymorphisms in several key disease-specific and therapy specific genes Also characterized is the relationship between these polymorphisms and the severity of Pulmonary Arterial Hypertension using either baseline hemodynamic or clinical surrogates for disease severity
Hypothesis Polymorphisms influence the efficacy and toxicity of specific Pulmonary Arterial Hypertension therapy as well as developmentseverity of PAH via their effect on PA remodeling drug response or metabolism
This study requires a one time 85 ml blood sample and clinical data to be obtained at initiation of therapy 4 months after initiation of therapy and 12 months after initiation of therapy
Hypothesis Polymorphisms influence the efficacy and toxicity of specific Pulmonary Arterial Hypertension therapy as well as developmentseverity of PAH via their effect on PA remodeling drug response or metabolism
This study requires a one time 85 ml blood sample and clinical data to be obtained at initiation of therapy 4 months after initiation of therapy and 12 months after initiation of therapy
Detailed Description:
This study will make use of a large population of well defined patients with Pulmonary Arterial Hypertension who were enrolled in Encysive Pharmaceuticals STRIDE clinical trials or who have received bosentan or ambrisentan for 4 months or longer This international study constitutes the largest clinical study of this deadly disease and in such has great potential to alter the clinical practice by revealing novel gene-drug interactions This study tests the hypothesis by executing the following aims
Aim 1 Determine in Pulmonary Arterial Hypertension the relationship between known disease-specific polymorphisms Serotonin transporter gene and PAI HindIII and variants in BMPR2 and SMAD4 with several well-defined clinical efficacy endpoints of sitaxsentan bosentan and ambrisentan therapy
Aim 2 Determine in Pulmonary Arterial Hypertension the relationship between existing potentially therapy-specific polymorphisms in the ET-1 ETAR ETBR NPR-C prostacyclin receptor and prostacyclin synthase with several well-defined clinical efficacy endpoints of sitaxsentan bosentan and ambrisentan therapy
Aim 3 Characterize the relationship between any treatment effect these polymorphisms and PAH severity using either clinical data or clinical surrogates for disease activity
This study was funded by the NIH from 2005 - 2009 In August 2009 a no-cost extension was granted and this study continued until the end of July 2010 Currently the study is still active and does still have several active sites participating however the study is funded by the internal institution and there is no contributing federal funding
Aim 1 Determine in Pulmonary Arterial Hypertension the relationship between known disease-specific polymorphisms Serotonin transporter gene and PAI HindIII and variants in BMPR2 and SMAD4 with several well-defined clinical efficacy endpoints of sitaxsentan bosentan and ambrisentan therapy
Aim 2 Determine in Pulmonary Arterial Hypertension the relationship between existing potentially therapy-specific polymorphisms in the ET-1 ETAR ETBR NPR-C prostacyclin receptor and prostacyclin synthase with several well-defined clinical efficacy endpoints of sitaxsentan bosentan and ambrisentan therapy
Aim 3 Characterize the relationship between any treatment effect these polymorphisms and PAH severity using either clinical data or clinical surrogates for disease activity
This study was funded by the NIH from 2005 - 2009 In August 2009 a no-cost extension was granted and this study continued until the end of July 2010 Currently the study is still active and does still have several active sites participating however the study is funded by the internal institution and there is no contributing federal funding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RC 4590 | OTHER | Allegheny General Hospital | None |