Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06009185
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2023-07-17
Brief Title:
Safety and Efficacy of BIA 5-1058 in PAH
Sponsor:
Bial - Portela C SA
Organization:
Bial - Portela C SA
Study Overview
Official Title:
An Open-label Multicentre Study to Evaluate the Safety and Efficacy of Zamicastat as Adjunctive Therapy in Long-term Treatment of Pulmonary Arterial Hypertension PAH Disease
Status:
COMPLETED
Status Verified Date:
2023-08
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:
None
Brief Summary:
This study aims to assess the safety and tolerability of the individual highest tolerated zamicastat doses achieved in the study BIA-51058-201 during long-term treatment in Pulmonary Arterial Hypertension PAH disease
Detailed Description:
This is an extension study with Pulmonary Arterial Hypertension PAH patients who are under treatment with zamicastat as adjunctive therapy in the study BIA-51058-201
For patients participating in this extension study visit Maintenance Period Visit 3 MPV3 of the study BIA-51058-201 will also be the first visit V1 of this extension study BIA-51058-202 Their treatment with zamicastat will be continued at their individual highest tolerated dose HTD for an additional 12 weeks 50 mg 100 mg 150 mg or 200 mg
Further visits will be performed 20 3 days V2 telephone 41 3 days V3 on-site 62 3 days V4 telephone and 83 3 days V5 on-site after V1 At V5 patients will have the opportunity to continue treatment with zamicastat in a compassionate use program Patients who will not participate in this compassionate use program will come to the following follow-up visits
Follow-up FU down-titration telephone 14 2 days after V5 only applicable in patients taking 150 mg or 200 mg zamicastat
FU visit on-site 14 2 days after last investigational medicinal product IMP intake
The data and safety monitoring board DSMB will periodically review the safety data and will issue a recommendation if the study can be continued as planned
For patients participating in this extension study visit Maintenance Period Visit 3 MPV3 of the study BIA-51058-201 will also be the first visit V1 of this extension study BIA-51058-202 Their treatment with zamicastat will be continued at their individual highest tolerated dose HTD for an additional 12 weeks 50 mg 100 mg 150 mg or 200 mg
Further visits will be performed 20 3 days V2 telephone 41 3 days V3 on-site 62 3 days V4 telephone and 83 3 days V5 on-site after V1 At V5 patients will have the opportunity to continue treatment with zamicastat in a compassionate use program Patients who will not participate in this compassionate use program will come to the following follow-up visits
Follow-up FU down-titration telephone 14 2 days after V5 only applicable in patients taking 150 mg or 200 mg zamicastat
FU visit on-site 14 2 days after last investigational medicinal product IMP intake
The data and safety monitoring board DSMB will periodically review the safety data and will issue a recommendation if the study can be continued as planned
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002796-18 | EUDRACT_NUMBER | None | None |