Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521190
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
ACOU085 for Hearing Loss Prevention in Testicular Cancer Patients Receiving Cisplatin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase IIa Randomized Double-blind and Placebo-controlled Multicenter Split Body Trial of Repeated Doses of ACOU085 for the Prevention of Hearing Loss in Testicular Cancer Patients Receiving Cisplatin
Status:
RECRUITING
Status Verified Date:
2024-07
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:
PROHEAR
Brief Summary:
Randomized double-blind placebo-controlled multicenter phase IIa clinical trial in adult male TCa patients with the risk to suffer from sensorineural hearing loss SNHL due to cisplatin therapy within a chemotherapeutic regimen of testicular cancer Patients will have an indication for a cisplatin-containing chemotherapy according to current guidelines and trial site tumor board recommendations The trial is designed to show efficacy safety and tolerability of ACOU085 administered into the middle ear using 3 transtympanic injections per ear prior to 3 planned and corresponding 3-week chemotherapeutic cycles The intra-individual control will be done by placebo injection into the respective contralateral middle ear
Detailed Description:
None
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