Clinical trial • Oncology
Etentamig (ABBV-383) for Light chain amyloidosis
Clinical trial of Etentamig (ABBV-383) for Light chain amyloidosis. None/Not specified-controlled. 60 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Light chain amyloidosis
Key dates
- Initial CTIS Submission Date
- 15-01-2024
- First CTIS Authorization Date
- 06-05-2024
Trial design
None/Not specified-controlled trial across 5 sites in France, Greece, Italy.
- Comparator
- None/Not specified
- Target Sample Size
- 60
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 85
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 60
France
- Earliest CTIS Part Ii Submission Date
- 17-04-2024
- Latest Decision Or Authorization Date
- 06-05-2024
- Processing Time Days
- 19
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Département de néphrologie et transplantation d'organes
- Principal Investigator Name
- Antoine Huart
- Principal Investigator Email
- huart.a@chu-toulouse.fr
- Contact Person Name
- Antoine Huart
- Contact Person Email
- huart.a@chu-toulouse.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Service d'Hématologie Clinique et Thérapie Cellulaire
- Principal Investigator Name
- Arnaud Jaccard
- Principal Investigator Email
- arnaud.jaccard@chu-limoges.fr
- Contact Person Name
- Arnaud Jaccard
- Contact Person Email
- arnaud.jaccard@chu-limoges.fr
Greece
- Earliest CTIS Part Ii Submission Date
- 04-04-2024
- Latest Decision Or Authorization Date
- 13-05-2024
- Processing Time Days
- 39
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Alexandra Hospital
- Department Name
- Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics
- Principal Investigator Name
- Efstathios Kastritis
- Principal Investigator Email
- ekastritis@med.uoa.gr
- Contact Person Name
- Efstathios Kastritis
- Contact Person Email
- ekastritis@med.uoa.gr
Italy
- Earliest CTIS Part Ii Submission Date
- 28-03-2024
- Latest Decision Or Authorization Date
- 08-05-2024
- Processing Time Days
- 41
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- General Medicine 2
- Principal Investigator Name
- Giovanni Palladini
- Principal Investigator Email
- Giovanni.palladini@unipv.it
- Contact Person Name
- Giovanni Palladini
- Contact Person Email
- Giovanni.palladini@unipv.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Department of Oncological and Hematological Diseases
- Principal Investigator Name
- Elena Zamagni
- Principal Investigator Email
- e.zamagni@unibo.it
- Contact Person Name
- Elena Zamagni
- Contact Person Email
- e.zamagni@unibo.it
Sponsor
Primary sponsor
- Full Name
- Abbvie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Etentamig (ABBV-383)
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