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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1319-5468 | Registry Identifier | WHO |
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This is an open-label, multi-center, single group, Phase 3 study for treatment with rilzabrutinib.
The purpose of this study is to provide continuation of rilzabrutinib treatment to adult participants with ITP who have completed the LTE of the LUNA 3 study in Japan, demonstrating clinically meaningful benefit as judged by the Investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rilzabrutinib | Experimental | 400 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rilzabrutinib | Drug | Pharmaceutical form:Tablet-Route of administration:Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| AEs including SAEs and AESIs | An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor is required | Until study completion, approximately 60 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number: 1001 | Tsuchiura | Ibaraki | 300-0028 | Japan | ||
| Investigational Site Number: 1002 |
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| Label | URL |
|---|---|
| LTS19407 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| Kanazawa |
| Ishikawa-ken |
| 920-8641 |
| Japan |
| Investigational Site Number: 1003 | Iruma-gun | Saitama | 350-0495 | Japan |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |