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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
Celgene
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Myelodysplastic Syndrome focused on measuring Expanded Access, Compassionate Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

-

Exclusion Criteria:

-

Sites / Locations

  • Celgene

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 26, 2018
Last Updated
July 16, 2020
Sponsor
Celgene
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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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