Expanded Access for ACE-011
Primary Purpose
Myelodysplastic Syndrome
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
ACE-011
Sponsored by
About this trial
This is an expanded access trial for Myelodysplastic Syndrome focused on measuring Expanded Access, Compassionate Use
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Sites / Locations
- Celgene
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03724227
Brief Title
Expanded Access for ACE-011
Official Title
Expanded Access for ACE-011
Study Type
Expanded Access
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
5. Study Description
Brief Summary
This is an expanded access program (EAP) for eligible participants designed to provide access to ACE-011.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
Expanded Access, Compassionate Use
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ACE-011
Other Intervention Name(s)
Sotatercept
Intervention Description
ACE-011 will be administered subcutaneous injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Facility Information:
Facility Name
Celgene
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Expanded Access for ACE-011
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