Pre-Approval Access for Administration of Daratumumab Subcutaneously (SC) in Participants Who Are Unable to Receive Intravenous (IV) Daratumumab
Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT04264884
Collaborator
(none)
Study Details
Study Description
Brief Summary
The purpose of this pre-approval access (PAA) program is to provide treatment to participants with serious/life-threatening diseases or conditions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Expanded Access
Official Title:
Daratumumab Subcutaneous Pre-approval Access Study
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT04264884
Other Study ID Numbers:
- CR108780
- 54767414MMY4031
First Posted:
Feb 11, 2020
Last Update Posted:
Jul 7, 2020
Last Verified:
Jul 1, 2020
Additional relevant MeSH terms: