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Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

Primary Purpose

Immune Thrombocytopenic Purpura

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fostamatinib Disodium
Sponsored by
Rigel Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenic Purpura

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Completed week 24 evaluation of Study C935788-047 or Study C935788-048 or discontinued early due to lack of response.
  • Able and willing to give written informed consent

Exclusion Criteria:

  • Discontinued participation in Study C935788-047 or Study C935788-048 for any reason other than lack of response
  • Poorly controlled hypertension during Study C935788-047 or Study C935788-048
  • Significant infection, an acute infection such as influenza, or known inflammatory process

Sites / Locations

  • Arizona Oncology Associates
  • Bleeding & Clotting Disorders Institute
  • Horizon Oncology Research, Inc
  • Center for Cancer and Blood Disorders
  • Weill Cornell Medical College/New York Presbyterian Hospital
  • Weill Cornell Medicine
  • East Carolina University, Brody School of Medicine
  • W.G. "Bill" Hefner VA Medical Center
  • Signal Point Clinical Research Center LLC
  • Concord Repatriation General Hospital
  • Liverpool Hospital
  • Prince of Wales Hospital
  • Westmead Hospital
  • Launceston General Hospital
  • The Alfred
  • Perth Blood Institute
  • Hanusch-Krankenhaus Wiener Gebietskrankenkasse
  • Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology;
  • UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology
  • UMHAT Aleksandrovska, EAD
  • MHAT Hristo Botev, AD, Vratsa, First Internal Department
  • Hamilton Health Sciences Corporation
  • St. Michael's Hospital
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Ostrava
  • Herlev Hospital
  • Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz. Belgyogyaszati Klinika
  • Istituto di Ematologia "Lorenzo e Ariosto Seràgnoli"
  • Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" - Clinica Ematologica
  • HAGA ziekenhuis
  • Haukeland universitetssykehus, Helse Bergen HF
  • Sykehuset Østfold Kalnes
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw
  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka
  • Lkinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne
  • SPZOZ Szpital Uniwersytecki w Krakowie Pracownia Separacji Krwinek i Bank Komórek Krwiotwórczych Klinika Hematologii
  • Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi
  • Specjalistyczny Gabinet Lekarski
  • Szpital Wojewodzki w Opolu
  • Instytut Hematologii I Transfuzjologii
  • Spitalul Clinic Colentina, Hematologie
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario La Paz
  • Hospital Universitari i Politécnic La Fe de Valencia
  • Colchester General Hospital
  • Royal Victoria Infirmary
  • Kent & Canterbury Hospital
  • James Paget University Hospital
  • St. James's Hospital
  • Leicester Royal Infirmary
  • Royal Liverpool University Hospital
  • Imperial College Healthcare NHS Trust
  • University College Hospital
  • Cancer and Haematology Centre
  • University Hospital of North Midlands NHS Trust, Royal Stoke University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fostamatinib Disodium

Arm Description

Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day

Outcomes

Primary Outcome Measures

Number of Participants with platelet count of at least 50,000/µL as a Measure of Safety and Efficacy

Secondary Outcome Measures

Full Information

First Posted
February 27, 2014
Last Updated
May 21, 2021
Sponsor
Rigel Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02077192
Brief Title
Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Official Title
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rigel Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether fostamatinib is safe and effective in treating patients with persistent/chronic Immune Thrombocytopenic Purpura (ITP) over a 5 year period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenic Purpura

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fostamatinib Disodium
Arm Type
Experimental
Arm Description
Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day
Intervention Type
Drug
Intervention Name(s)
Fostamatinib Disodium
Other Intervention Name(s)
R935788, R788, Fostamatinib
Intervention Description
Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day
Primary Outcome Measure Information:
Title
Number of Participants with platelet count of at least 50,000/µL as a Measure of Safety and Efficacy
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed week 24 evaluation of Study C935788-047 or Study C935788-048 or discontinued early due to lack of response. Able and willing to give written informed consent Exclusion Criteria: Discontinued participation in Study C935788-047 or Study C935788-048 for any reason other than lack of response Poorly controlled hypertension during Study C935788-047 or Study C935788-048 Significant infection, an acute infection such as influenza, or known inflammatory process
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rigel Pharmaceuticals, Inc.
Organizational Affiliation
Rigel Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Bleeding & Clotting Disorders Institute
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Horizon Oncology Research, Inc
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Weill Cornell Medical College/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
East Carolina University, Brody School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
W.G. "Bill" Hefner VA Medical Center
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Signal Point Clinical Research Center LLC
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Launceston General Hospital
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Perth Blood Institute
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Hanusch-Krankenhaus Wiener Gebietskrankenkasse
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology;
City
Sofia
State/Province
BG
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT Aleksandrovska, EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
MHAT Hristo Botev, AD, Vratsa, First Internal Department
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Hamilton Health Sciences Corporation
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Herlev Hospital
City
Herlev
State/Province
DK
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz. Belgyogyaszati Klinika
City
Pecs
ZIP/Postal Code
H-7624
Country
Hungary
Facility Name
Istituto di Ematologia "Lorenzo e Ariosto Seràgnoli"
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" - Clinica Ematologica
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
HAGA ziekenhuis
City
Den Haag
State/Province
NL
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Haukeland universitetssykehus, Helse Bergen HF
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Sykehuset Østfold Kalnes
City
Grålum
ZIP/Postal Code
1714
Country
Norway
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw
City
Wroclaw
State/Province
Dolnoslaski
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. J. Korczaka
City
Slupsk
State/Province
PO
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Lkinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
SPZOZ Szpital Uniwersytecki w Krakowie Pracownia Separacji Krwinek i Bank Komórek Krwiotwórczych Klinika Hematologii
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Specjalistyczny Gabinet Lekarski
City
Lublin
ZIP/Postal Code
20-601
Country
Poland
Facility Name
Szpital Wojewodzki w Opolu
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Facility Name
Instytut Hematologii I Transfuzjologii
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Spitalul Clinic Colentina, Hematologie
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitari i Politécnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Colchester General Hospital
City
Colchester
State/Province
Essex
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle-upon-Tyne
State/Province
UK
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Kent & Canterbury Hospital
City
Canterbury
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
James Paget University Hospital
City
Great Yarmouth
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
Facility Name
St. James's Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L78XP
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
University College Hospital
City
London
ZIP/Postal Code
WC1E 6AG
Country
United Kingdom
Facility Name
Cancer and Haematology Centre
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
University Hospital of North Midlands NHS Trust, Royal Stoke University Hospital
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33995988
Citation
Cooper N, Altomare I, Thomas MR, Nicolson PLR, Watson SP, Markovtsov V, Todd LK, Masuda E, Bussel JB. Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib. Ther Adv Hematol. 2021 Apr 30;12:20406207211010875. doi: 10.1177/20406207211010875. eCollection 2021.
Results Reference
derived

Learn more about this trial

Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

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