Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623890
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
A Study to Learn More About the Long-Term Safety of BIIB141 Omaveloxolone in Participants With Friedreichs Ataxia Who Are Prescribed it for the First Time
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Observational Multinational Post-Marketing Registry of Omaveloxolone-Treated Patients With Friedreichs Ataxia
Status:
NOT_YET_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:
In this study researchers will learn more about the safety of BIIB141 also known as omaveloxolone or SKYCLARYS This is a drug available for doctors to prescribe for people with Friedreichs Ataxia also known as FA This is known as an observational study which collects health information about study participants without changing their medical care Participants for this study will be found using a group called the Friedreichs Ataxia Global Clinical Consortium FA GCC This is a group of study research centers that help provide clinical care for people with FA
The main objective of this study is to collect safety information in participants with FA who are being prescribed BIIB141 for the first time by their own doctors
The main question researchers want to answer in this study is
How many participants had serious adverse events SAEs An adverse event is considered serious when it results in death is life-threatening causes lasting problems or requires hospital care
How many participants had adverse events AEs related to heart failure or liver damage caused by the drug
Researchers will also learn more about
Why and when participants stopped treatment left the study or took more of the drug than was prescribed
This study will be done as follows
Participants will be screened to check if they can join the study
After joining the study the participants must start treatment with BIIB141 within 6 months
During the study each participants doctor will decide how often the participant visits the study research center to check on their health This will be based on the doctors own clinical judgment and what is recommended by the drugs label Most participants will visit their study research center at least once a year
Data from the participants regular visits to their doctor will be collected at 1 month 2 months 3 months 6 months 12 months 24 months 36 months 48 months and 60 months
Each participant will be in the study for up to 5 years
The main objective of this study is to collect safety information in participants with FA who are being prescribed BIIB141 for the first time by their own doctors
The main question researchers want to answer in this study is
How many participants had serious adverse events SAEs An adverse event is considered serious when it results in death is life-threatening causes lasting problems or requires hospital care
How many participants had adverse events AEs related to heart failure or liver damage caused by the drug
Researchers will also learn more about
Why and when participants stopped treatment left the study or took more of the drug than was prescribed
This study will be done as follows
Participants will be screened to check if they can join the study
After joining the study the participants must start treatment with BIIB141 within 6 months
During the study each participants doctor will decide how often the participant visits the study research center to check on their health This will be based on the doctors own clinical judgment and what is recommended by the drugs label Most participants will visit their study research center at least once a year
Data from the participants regular visits to their doctor will be collected at 1 month 2 months 3 months 6 months 12 months 24 months 36 months 48 months and 60 months
Each participant will be in the study for up to 5 years
Detailed Description:
The primary objective of this study is to assess the long-term safety of omaveloxolone as prescribed to participants with FA in the real-world setting including characterization of all drug-induced liver injury DILI and congestive heart failure CHF AEs The secondary objective of this study is to capture the reasons and timing of omaveloxolone treatment interruptions discontinuations and drug overdose
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