Expanded Access of Fostamatinib in Patients With Persiste... | NCT03363334

Studies
Expanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory ITP

NCT03363334

Sponsor

Rigel Pharmaceuticals

Status

No longer available

Last Update Posted

Aug 1, 2018Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Immune Thrombocytopenic Purpura

Interventions

Fostamatinib disodium 100 mg
Fostamatinib disodium 150 mg

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

No longer available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 28, 2017

First Submission Date that Met QC Criteria

Nov 30, 2017

First Posted Date

Dec 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2018

Last Update Posted Date

Aug 1, 2018Actual

Description Module

Brief Summary

C-935788-055 is an open-label, multi-center, expanded access (EAP) study.

Detailed Description

The purpose of the program is to provide Fostamatinib in an Expanded Access setting to subjects who meet the selection criteria.

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Intermediate-type Population

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fostamatinib disodium 100 mg	Drug	Fostamatinib Disodium tablet 100 mg PO bid (morning and evening)		Fostamatinib R935788 R788
Fostamatinib disodium 150 mg	Drug	Fostamatinib Disodium tablet 150 mg PO bid (morning and evening)		Fostamatinib R935788 R788

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient with chronic or persistent ITP.
Must have failed or are unable to receive standard of care treatments for ITP.
Must have at least two platelet counts < 30,000/µL during the last 2 months prior to screen date.

Exclusion Criteria:

ITP associated with lymphoma, chronic lymphocytic leukemia, transplant, or thrombocytopenia associated with myeloid dysplasia.
Subject has uncontrolled or poorly controlled hypertension.
Any of the following laboratory abnormalities: neutrophil count of < 1,500/µL, or transaminase levels (ALT, AST) > 1.5x ULN, total bilirubin > 2.0 mg/dL.
Active HBV or HCV infection.
Current or recent enrollment in an investigational drug or device study.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Anne-Marie Duliege, M.D.	Rigel Pharmaceuticals, Inc., Chief Medical Officer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D016553	Purpura, Thrombocytopenic, Idiopathic

Ancestor Terms

ID	Term
D011696	Purpura, Thrombocytopenic
D011693	Purpura
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided