Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05128929
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2021-11-11
Brief Title:
Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease The SATURN Study
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease The SATURN Study
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SATURN
Brief Summary:
This study is a prospective randomized double-blind study of H01 Hymecromone in adults with pulmonary hypertension PH The primary objective of this study is to evaluate the safety and tolerability of oral H01 and the potential benefit of oral H01 on clinical measures of PH disease severity over 24 weeks
Study Hypothesis
Oral H01 at doses of 1600 mg per day will be a safe and well-tolerated agent in adults with pulmonary hypertension over 24 weeks
Study Hypothesis
Oral H01 at doses of 1600 mg per day will be a safe and well-tolerated agent in adults with pulmonary hypertension over 24 weeks
Detailed Description:
The studys objectives are to evaluate
The changes in clinical and functional measures pulmonary function test pulmonary vascular resistance mean pulmonary arterial pressure and 6 Minute Walk Distance Test in adults with PH treated with oral H01
The safety and tolerability of the use of oral H01 for PH over 24 weeks using health criteriaevaluations Common Terminology Criteria for Adverse Events CTCAE quality of life QOL score EMPHASIS-10 score and St George Respiratory Questionnaire SGRQ score
To investigate the clinical efficacy pharmacokinetic PK and pharmacodynamic PD markers serum HA concentration inflammatory markers and cytokines NT-proBNP and H01 and metabolite serum concentrations in this population following oral H01 use
The changes in clinical and functional measures pulmonary function test pulmonary vascular resistance mean pulmonary arterial pressure and 6 Minute Walk Distance Test in adults with PH treated with oral H01
The safety and tolerability of the use of oral H01 for PH over 24 weeks using health criteriaevaluations Common Terminology Criteria for Adverse Events CTCAE quality of life QOL score EMPHASIS-10 score and St George Respiratory Questionnaire SGRQ score
To investigate the clinical efficacy pharmacokinetic PK and pharmacodynamic PD markers serum HA concentration inflammatory markers and cytokines NT-proBNP and H01 and metabolite serum concentrations in this population following oral H01 use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None