Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05798923
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-03-13
Brief Title:
A Phase 2a Study of LAM-001 for the Treatment of Pulmonary Hypertension
Sponsor:
OrphAI Therapeutics
Organization:
OrphAI Therapeutics
Study Overview
Official Title:
A Phase 2a Single-Arm Open-Label Exploratory Study to Assess the Effects of LAM-001 for the Treatment of Pulmonary Hypertension
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a clinical trial to assess the efficacy and safety of LAM-001 as an add-on therapy for the treatment pulmonary hypertension
Detailed Description:
This is a Phase 2a single-arm open-label exploratory study assessing the efficacy and safety of LAM-001 as an add-on therapy for the treatment of WHO functional class III subjects with WSPH Group-1 or Group-3 pulmonary hypertension
Approximately fifteen participants will receive standard of care plus LAM-001 once daily for the first 24 weeks of the study Core Study
Participants who complete the first 24 weeks on treatment and appear to have a favorable benefit-risk profile will be eligible to continue receiving LAM-001 for the remainder of the study Extension Period up of 12 months
All participants will complete evaluations during a Follow-Up Period of 4 weeks
Approximately fifteen participants will receive standard of care plus LAM-001 once daily for the first 24 weeks of the study Core Study
Participants who complete the first 24 weeks on treatment and appear to have a favorable benefit-risk profile will be eligible to continue receiving LAM-001 for the remainder of the study Extension Period up of 12 months
All participants will complete evaluations during a Follow-Up Period of 4 weeks
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