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Immune Thrombocytopenic PurpuraPhase 3FITNCT02076412

A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

A Phase 3 study testing Fostamatinib Disodium in people with Immune Thrombocytopenic Purpura, run by Rigel Pharmaceuticals at 35 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Immune Thrombocytopenic Purpura
What is being tested?
Fostamatinib Disodium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
35 sitesin 9 countries
Study dates
Jan 2015to Aug 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of persistent/chronic ITP for at least 3 months
  • Average platelet count< 30,000/µL (and none > 35,000 unless as a result of rescue therapy) from at least 3 qualifying counts

Who cannot join

  • Clinical diagnosis of autoimmune hemolytic anemia
  • Uncontrolled or poorly controlled hypertension
  • History of coagulopathy including prothrombotic conditions

Trial locations and contacts

35 sites in 9 countries.

35 sites in 9 countries

Poland8 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Szpital Uniwersytecki

    Krakow, 31-501

  • Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi

    Lodz, 93-510

  • Specjalistyczny Gabinet Lekarski

    Lublin, 20-081

  • Szpital Wojewodzki w Opolu

    Opole, 45-064

  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka

    Słupsk, 76-200

  • Instytut Hematologii I Transfuzjologii

    Warsaw, 02-776

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw

    Wroclaw, 50-367

Other trials in Poland

Czechia5 sites

  • Fakultni nemocnice Brno

    Brno, CZ, 625 00

  • Hospital Kyjov

    Kyjov, CZ, 69733

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice, Linterní Klinika, Klinika hematologie

    Prague, 128 08

Other trials in Czechia

Germany5 sites

  • Charit Berlin - Campus Benjamin Franklin

    Berlin, 12203

  • Marien Hospital Duesseldorf

    Düsseldorf, 40479

  • Universittsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Giessen und Marburg (UKGM)

    Giessen, DE, 35392

  • Werlhof Institut GmbH

    Hanover, DE, 30159

Other trials in Germany

Bulgaria4 sites

  • UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology

    Pleven, 5800

  • Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology;

    Sofia, BG, 1756

  • UMHAT Aleksandrovska, EAD, Clinic of Clinical Hematology

    Sofia, 1431

  • MHAT Hristo Botev, AD, Vratsa, First Internal Department

    Vratsa, BG, 3000

Other trials in Bulgaria

Spain4 sites

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

  • Hospital Universitariola Paz

    Madrid, 28046

  • Hospital Universitari i Politécnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

Austria3 sites

  • LKH Feldkirch at LKH Rankweil

    Rankweil, 6830

  • Medizinische Universitaet Wien / AKH Wien

    Vienna, AU, 1090

  • Hanusch-Krankenhaus Wiener Gebietskrankenkasse

    Vienna, AU, 1140

Other trials in Austria

Romania3 sites

  • Spitalul Clinic Colentina, Hematologie

    Bucharest, 020125

  • Spitalul Clinic Coltea, Hematologie

    Bucharest, 030171

  • Spitalul Clinic Judetean de Urgenta Tirgu-Mures, Sectia Medicina Interna 1, Compartiment Hematologie

    Târgu Mureş, Mureș County, 540136

Other trials in Romania

Norway2 sites

  • Haukeland University Hospital

    Bergen, 5021

  • Sykehuset Østfold Fredrikstad

    Fredrikstad, 1606

Other trials in Norway

United States1 site

  • Hematology Oncology Associates of Rockland Division of Highland Medical PC

    Nyack, New York, 10960

Other trials in United States

About this study

Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).

Being tested
Fostamatinib Disodium, Placebo
Medical subject headings
Purpura, Thrombocytopenic, Idiopathic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fostamatinib DisodiumDrug

    Also called R935788, R788, Fostamatinib

    Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.

  • PlaceboDrug

    Placebo tablet PO bid (morning and evening)

Study groups in NCT02076412
Study groupRoleWhat they receive
Fostamatinib DisodiumExperimentalFostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
Receives: Drug: Fostamatinib Disodium
PlaceboOtherPlacebo tablet PO bid (morning and evening) over the course of 24 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Stable Platelet Response of at Least 50,000/µL

    Stable platelet response by Week 24 defined as a platelet count of at least 50,000/µL on at least 4 of the 6 visits between Weeks 14-24

    Measured: Baseline to Week 24

Secondary outcomes (6)

  1. Number of Participants With Platelet Count ≥ 50,000/µL at Week 12

    Platelet Count ≥ 50,000/µL at Week 12

    Measured: Baseline to Week 12

  2. Number of Participants With Platelet Count ≥ 50,000/µL at Week 24

    Platelet Count ≥ 50,000/µL at Week 24

    Measured: Baseline to Week 24

  3. Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 12

    Among subjects with a baseline platelet count < 15,000/μL, achievement of a count ≥ 30,000/μL and at least 20,000/μL above baseline at Week 12.

    Measured: Baseline to Week 12

  4. Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 24

    Among subjects with a baseline platelet count < 15,000/μL, achievement of a count ≥ 30,000/μL and at least 20,000/μL above baseline at Week 24

    Measured: Baseline to Week 24

  5. Frequency and Severity of Bleeding According to 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.

    Measured: Baseline to Week 24

  6. Frequency and Severity of Bleeding According to the 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.

    Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02076412
Sponsor's protocol ID
C-935788-048
Other IDs
2013-005453-76
Acronym
FIT
Status last verified
Jan 2019
First submitted
26 Feb 2014
Last updated
25 Jan 2019
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 33995988

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fostamatinib Disodium in people with Immune Thrombocytopenic Purpura, run by Rigel Pharmaceuticals at 35 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Poland, Czechia, Germany, Bulgaria, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Stable Platelet Response of at Least 50,000/µL (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02076412, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.

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