Ignite Creation Date:
2024-05-06 @ 12:29 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03775421
Status:
TERMINATED
Last Update Posted:
2023-03-07
First Post:
2018-11-21
Brief Title:
An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Prospective Multi-center Single-arm Open-label Long-term Study Assessing the Safety Tolerability and Effectiveness of Macitentan in Fontan-palliated Adult and Adolescent Subjects
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
As The RUBATO DB study NCT03153137 did not show any benefit of treatment with macitentan in Fontan-palliated participants the sponsor has decided to terminate the RUBATO OL study NCT03775421 No new safety observations were made
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RUBATO OL
Brief Summary:
The aim of this open-label OL trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind DB study AC-055H301 NCT03153137 This OL trial studies the long-term effect of macitentan in Fontan-palliated patients as it is not known if the effect of macitentan is sustained beyond 52 weeks end of the parent RUBATO DB study In addition the trial also studies the long-term safety of macitentan as this is also unknown Furthermore the opportunity will be given to patients who were on placebo in the parent RUBATO DB study to receive macitentan 10 mg and benefit from a potentially active treatment
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002821-45 | EUDRACT_NUMBER | None | None |