Trial record 1 of 1 for:
ASY15905
Collection of Blood Samples From Patients With Relapsing MS Who Developed ITP After Receiving Lemtrada (LEMTRADA-ITP)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03784898 |
Recruitment Status :
Completed
First Posted : December 24, 2018
Results First Posted : July 20, 2020
Last Update Posted : March 28, 2022
|
Sponsor:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other |
Condition |
Multiple Sclerosis |
Intervention |
Other: Blood draw for future biomarker analysis |
Enrollment | 13 |
Participant Flow
Recruitment Details | The study was conducted at a single site in the United States. A total of 14 participants were screened between 8 February 2019 to 11 December 2019, of which,1 participant was screen failure. Screen failures was mainly due to inclusion criteria not met. |
Pre-assignment Details | A total of 13 participants were enrolled in the study. |
Arm/Group Title | Participants Diagnosed With ITP |
---|---|
![]() |
Participants with Relapsing Forms of Multiple Sclerosis (RMS) who developed Immune thrombocytopenic purpura (ITP) after Lemtrada treatment were included in this study and provided blood samples for future genetic testing and biomarker analysis. |
Period Title: Overall Study | |
Started | 13 |
Completed | 13 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | Participants Diagnosed With ITP | |
---|---|---|
![]() |
Participants with RMS who developed ITP after Lemtrada treatment were included in this study and provided blood samples for future genetic testing and biomarker analysis. | |
Overall Number of Baseline Participants | 13 | |
![]() |
Analysis was performed on all enrolled participants.
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||
Number Analyzed | 13 participants | |
48.2 (7.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 13 participants | |
Female |
10 76.9%
|
|
Male |
3 23.1%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 13 participants | |
American Indian or Alaska Native |
0 0.0%
|
|
Asian |
0 0.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
|
Black or African American |
0 0.0%
|
|
White |
13 100.0%
|
|
More than one race |
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Name/Title: | Trial Transparency Team |
Organization: | Sanofi |
Phone: | 800-633-1610 ext 1# |
EMail: | Contact-US@sanofi.com |
Responsible Party: | Sanofi ( Genzyme, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT03784898 |
Other Study ID Numbers: |
ASY15905 U1111-1225-1333 |
First Submitted: | December 20, 2018 |
First Posted: | December 24, 2018 |
Results First Submitted: | July 2, 2020 |
Results First Posted: | July 20, 2020 |
Last Update Posted: | March 28, 2022 |