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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005452-15 | EudraCT Number |
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The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fostamatinib Disodium | Experimental | Subjects begin with Fostamatinib Disodium tablet 100 mg PO bid and increase to 150 mg big after week 4 based on platelet count and tolerability. |
|
| Placebo | Other | Placebo tablet PO bid (morning and evening) over the course of 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fostamatinib disodium | Drug | Fostamatinib (100 mg PO bid or 150 mg PO bid) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Stable Platelet Response (Count of ≥50,000/µL on at Least 4 of the Last 6 Scheduled Visits Between Weeks 14 and 24) | A stable platelet response by Week 24 defined as a platelet count of at least 50,000/μL on at least 4 of the last 6 scheduled visits between Weeks 14 and 24 | From Week 14 to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Platelet Count ≥ 50,000/µL at Week 12 | Platelet Count ≥ 50,000/µL at Week 12 | Week 12 |
| Number of Participants With Platelet Count ≥ 50,000/µL at Week 24 | Platelet Count ≥ 50,000/µL at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rigel Pharmaceuticals, Inc. | Rigel Pharmaceuticals,Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates | Tucson | Arizona | 85710 | United States | ||
| University of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33995988 | Derived | 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. |
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76 patients were enrolled from July 2014 to April 2016
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| ID | Title | Description |
|---|---|---|
| FG000 | Fostamatinib Recipient | Fostamatinib (100 mg PO bid or 150 mg PO bid) |
| FG001 | Placebo Recipient | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Placebo | Drug | Placebo tablet PO bid (morning and evening) over the course of 24 weeks |
|
| Week 24 |
| Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 12. | Number of subjects with baseline platelet count <15,000/μL who showed platelet count increase to ≥30,000/μL and ≥20,000/μL from baseline count at Week 12. | Baseline to Week 12 |
| Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 24. | Number of subjects with baseline platelet count <15,000/μL who showed platelet count increase to ≥30,000/μL and ≥20,000/μL from baseline count at Week 24. | Baseline to Week 24 |
| Mean of the ITP Bleeding Score (IBLS) | The ITP Bleeding Scale (IBLS) is an immune thrombocytopenic purpura (ITP)-specific bleeding score used to analyze the correlation of clinical and laboratory platelet variables with bleeding. The IBLS comprises of 11 grades from 0 (none) to 2 (marked bleeding) by history over the previous week or by exam; 2 being worse. These 11 grades include: skin by physical exam, oral by physical exam, skin by history, oral by history, epistaxis, gastrointestinal, urinary, gynecological, pulmonary, intracranial hemorrhage, and subconjunctival hemorrhage. After each grade is scored, the mean value for all 11 grades is calculated (lowest score being 0 and highest score being 2) for each subject visit. LOCF method was used to impute any missing data. The mean of the IBLS scores across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint. | Assessed over the 24-week study period |
| Mean of World Health Organization (WHO) Bleeding Scale | The World Health Organization (WHO) bleeding scale is a standardized grading scale created to measure the severity of bleeding. The scale is a clinical investigator-assessed five-point scale with a score range starting at the lowest 0=No bleeding, 1 = Petechiae, 2=Mild blood loss, 3=Gross blood loss, to the worse 4=Debilitating blood loss. The WHO bleeding scale is scored by history over the previous-week or by exam. After each grade is scored, the mean value is calculated (lowest score being 0 [no bleeding] to the highest score being 4 [debilitating blood loss]) for each visit. LOCF method was used to impute any missing data. The mean of the WHO bleeding scale across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint. | Assessed over the 24-week study period |
| Los Angeles |
| California |
| 90089 |
| United States |
| Lakeland Regional Cancer Center | Lakeland | Florida | 33805-1965 | United States |
| Bleeding & Clotting Disorders Institute | Peoria | Illinois | 61614 | United States |
| Horizon Oncology Research, Inc | Lafayette | Indiana | 47905 | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Weill Cornell Medical College/New York Presbyterian Hospital | New York | New York | 10065 | United States |
| Pitt County Memorial Hospital | Greenville | North Carolina | 27858 | United States |
| Bill Hefner VA Medical Center | Salisbury | North Carolina | 28144 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Signal Point Clinical Research Center LLC | Middletown | Ohio | 45042 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| St George Hospital | Kogarah | New South Wales | 2217 | Australia |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Launceston General Hospital | Launceston | Tasmania | 7250 | Australia |
| Frankston Hospital | Frankston | Victoria | 3199 | Australia |
| Dept of Haematology, The Alfred Hospital and Monash Medical Centre | Melbourne | Victoria | 3004 | Australia |
| Perth Blood Institute | Nedlands | Western Australia | 6009 | Australia |
| Hamilton Health Sciences Corporation | Hamilton | Ontario | L8N 3Z5 | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1 H8L6 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B1W8 | Canada |
| Herlev Hospital University of Copenhagen, Department of Hematology L124 | Herlev | DK | 2730 | Denmark |
| Dept. of Haematology, Odense University Hospital | Odense C | DK | DK-5000 | Denmark |
| Hematological department, Roskilde Hospital | Roskilde | DK | 4000 | Denmark |
| Aarhus University Hospital | Aalborg | 9000 | Denmark |
| Semmelweis University 1st | Budapest | H-1083 | Hungary |
| University of Debrecen | Debrecen | H-1083 | Hungary |
| Pecs University | Pécs | H-7624 | Hungary |
| Ematologia - Padigilione 8, Policinico S. Orsola Malpighi, Azienda Ospedaliero Universitaria di Bologna | Bologna | 40138 | Italy |
| Ospedale San Raffaele S.r.l. Dipartimento di Oncoematologia | Milan | 20132 | Italy |
| Universitã Federico II di Napoli | Naples | 80131 | Italy |
| OspedaleCivile-ClinicaEmatologica/PUGD | Udine | 33100 | Italy |
| ULSS 6 Vicenza-Ospedale San Bortolo di Vicenza | Vicenza | Italy |
| HAGA ziekenhuis | Haag | NL | 2545 CH | Netherlands |
| Kent & Canterbury Hospital | Kent | Canterbury | CT1 3NG | United Kingdom |
| Colchester General Hospital | Colchester | Essex | CO4 5JL | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | UK | L78XP | United Kingdom |
| St. James's Hospital | Leeds | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Royal London Hospital | London | E1 2ES | United Kingdom |
| Hammersmith Hospital, Catherine Lewis Centre | London | W12 0HS | United Kingdom |
| University College Hospital | London | WC1E 6HX | United Kingdom |
| Manchester Royal Infirmary | Manchester | M139WL | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| James Paget University Hospital | Norfolk | NR31 6LA | United Kingdom |
| Oxford University Hospital | Oxford | OX3 9BQ | United Kingdom |
| University Hospital of North Staffordshire | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Sandwell General Hospital | West Bromwich | B71 4HJ | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
ITT Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fostamatinib Recipient | Fostamatinib (100 mg PO bid or 150 mg PO bid) |
| BG001 | Placebo Recipient | Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Stable Platelet Response (Count of ≥50,000/µL on at Least 4 of the Last 6 Scheduled Visits Between Weeks 14 and 24) | A stable platelet response by Week 24 defined as a platelet count of at least 50,000/μL on at least 4 of the last 6 scheduled visits between Weeks 14 and 24 | Posted | Count of Participants | Participants | From Week 14 to Week 24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Platelet Count ≥ 50,000/µL at Week 12 | Platelet Count ≥ 50,000/µL at Week 12 | Posted | Count of Participants | Participants | Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Platelet Count ≥ 50,000/µL at Week 24 | Platelet Count ≥ 50,000/µL at Week 24 | Posted | Count of Participants | Participants | Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 12. | Number of subjects with baseline platelet count <15,000/μL who showed platelet count increase to ≥30,000/μL and ≥20,000/μL from baseline count at Week 12. | Posted | Count of Participants | Participants | Baseline to Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 24. | Number of subjects with baseline platelet count <15,000/μL who showed platelet count increase to ≥30,000/μL and ≥20,000/μL from baseline count at Week 24. | Posted | Count of Participants | Participants | Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean of the ITP Bleeding Score (IBLS) | The ITP Bleeding Scale (IBLS) is an immune thrombocytopenic purpura (ITP)-specific bleeding score used to analyze the correlation of clinical and laboratory platelet variables with bleeding. The IBLS comprises of 11 grades from 0 (none) to 2 (marked bleeding) by history over the previous week or by exam; 2 being worse. These 11 grades include: skin by physical exam, oral by physical exam, skin by history, oral by history, epistaxis, gastrointestinal, urinary, gynecological, pulmonary, intracranial hemorrhage, and subconjunctival hemorrhage. After each grade is scored, the mean value for all 11 grades is calculated (lowest score being 0 and highest score being 2) for each subject visit. LOCF method was used to impute any missing data. The mean of the IBLS scores across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint. | Posted | Mean | Standard Deviation | scores on a scale | Assessed over the 24-week study period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean of World Health Organization (WHO) Bleeding Scale | The World Health Organization (WHO) bleeding scale is a standardized grading scale created to measure the severity of bleeding. The scale is a clinical investigator-assessed five-point scale with a score range starting at the lowest 0=No bleeding, 1 = Petechiae, 2=Mild blood loss, 3=Gross blood loss, to the worse 4=Debilitating blood loss. The WHO bleeding scale is scored by history over the previous-week or by exam. After each grade is scored, the mean value is calculated (lowest score being 0 [no bleeding] to the highest score being 4 [debilitating blood loss]) for each visit. LOCF method was used to impute any missing data. The mean of the WHO bleeding scale across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint. | Posted | Mean | Standard Deviation | scores on a scale | Assessed over the 24-week study period |
|
|
24 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fostamatinib Recipient | Fostamatinib (100 mg PO bid or 150 mg PO bid) | 0 | 51 | 8 | 51 | 49 | 51 |
| EG001 | Placebo Recipient | Placebo | 1 | 25 | 5 | 25 | 19 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Immune Thrombocytopenic Purpura | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Retinal Tear | Eye disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Rash | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne-Marie Duliege, MD | Rigel | 650-624-1100 | clinicaltrials@rigel.com |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C523665 | fostamatinib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|