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Purpura, Thrombocytopaenic, IdiopathicPhase 3RAISENCT00370331

RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag

A Phase 3 study testing eltrombopag in people with Purpura, Thrombocytopaenic, Idiopathic, run by GlaxoSmithKline at 115 sites in 25 countries.

Completed

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

Official record
Search all trials

Trial summary

The rationale for this Phase III study is to evaluate the 6 month safety and efficacy of eltrombopag in the treatment of previously treated subjects with chronic ITP. The starting dose of eltrombopag, 50 mg, once daily was selected based upon the observed efficacy, safety and pharmacokinetics in a dose-finding Study… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Purpura, Thrombocytopaenic, Idiopathic
What is being tested?
eltrombopag
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
197 participants
Where
115 sitesin 25 countries
Study dates
Nov 2006to Jul 2008
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

  • A subject will be eligible for inclusion in this study only if all of the following criteria apply:
  • Subject has signed and dated a written informed consent.
  • Adults (≥18 years) diagnosed with chronic ITP according to the American Society for Hematology/British Committee for Standards in Hematology (ASH/BCSH) guidelines [George, 1996; BCSH, 2003], and platelet count < 30,000/μL on Day 1 (or within 24 hours prior to dosing on Day 1). In addition, a peripheral blood smear should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia (e.g. pseudothrombocytopenia, myelofibrosis). The physical examination should not suggest any disease which may cause thrombocytopenia other than ITP.
  • Subjects who have previously received one or more prior ITP therapies. Previous treatments for ITP include but are not limited to corticosteroids, immunoglobulins, azathioprine, danazol, cyclophosphamide and/or rituximab.
  • Subjects must have either initially responded (platelet count > 100,000/μL) to a previous ITP therapy or have had a bone marrow examination consistent with ITP within 3 years to rule out myelodysplastic syndromes or other causes of thrombocytopenia.
  • Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 1 week prior to randomization and the platelet count must show a clear downward trend after the last treatment with immunoglobulins. Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to randomization, or clearly be ineffective.
Show all 19Show fewer
  • Subjects treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to randomization. Subjects treated with cyclosporine A, mycophenolate mofetil or danazol must be receiving a dose that has been stable for at least 3 months prior to randomization. The medication should be continued with a stable dose for the initial 6 weeks of study "Concomitant ITP Therapy")
  • Prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) must be within 80 to 120% of the normal range with no history of hypercoagulable state.
  • A complete blood count (CBC), within the reference range (including WBC differential not indicative of a disorder other than ITP), with the following exceptions:
  • < 30,000 platelets/μL on Day 1 (or within 24 hours of Day 1) is required for inclusion,
  • Hemoglobin: Subjects with hemoglobin levels between 10 g/dL (100 g/L) and the lower limit of normal are eligible for inclusion, if anemia is clearly attributable to ITP (excessive blood loss).
  • ANC ≥ 1500/μL (1.5 x 10^9/L) is required for inclusion (elevated WBC/ANC due to steroid treatment is acceptable).
  • The following clinical chemistries MUST NOT exceed the upper limit of normal (ULN) reference range by more than 20%: creatinine, ALT, AST, total bilirubin, and alkaline phosphatase. In addition, total albumin must not be below the lower limit of normal (LLN) by more than 10%.
  • Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subjects) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or of childbearing potential and use one of the following highly effective methods of contraception (i.e., Pearl Index <1.0%) from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study:
  • Complete abstinence from intercourse;
  • Intrauterine device (IUD);
  • Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide);
  • Male partner is sterile prior to entry into the study and is the only partner of the female;
  • Systemic contraceptives (combined or progesterone only). Subject is able to understand and comply with protocol requirements and instructions and intends to complete the study as planned.

Who cannot join

  • A subject will NOT be eligible for inclusion in this study if any of the following criteria apply:
  • Any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g., thrombocytopenia is secondary to another disease).
  • Concurrent malignant disease and/or history of cancer treatment with cytotoxic chemotherapy and/or radiotherapy.
  • Any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), AND ≥ two of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, etc), or any other family history of arterial or venous thrombosis.
  • Pre-existing cardiovascular disease (congestive heart failure, New York Heart Association [NYHA] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), or subjects with a QTc >450 msec.
  • Female subjects who are nursing or pregnant (positive serum or urine b-human chorionic gonadotrophin pregnancy test) at screening or pre-dose on Day 1.
Show all 14Show fewer
  • History of alcohol/drug abuse.
  • Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
  • Subject treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for > 3 consecutive days within 2 weeks of the study start and until the end of the study.
  • History of platelet agglutination abnormality that prevents reliable measurement of platelet counts.
  • All subjects with secondary immune thrombocytopenia, including those with laboratory or clinical evidence of HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, hepatitis C virus infection, or any evidence for active hepatitis at the time of subject screening. If a potential subject has no clinical history that would support HIV infection or hepatitis infection, no further laboratory screening is necessary; however, standard medical practice would suggest further evaluation of patients who have risk factors for these infections.
  • Previous participation in a clinical study with eltrombopag.
  • Patients planning to have cataract surgery.
  • In France, a subject is neither affiliated with nor a beneficiary of a social security category.

Trial locations and contacts

115 sites in 25 countries.

115 sites in 25 countries

United States26 sites

  • GSK Investigational Site

    Arlington, Virginia, 22205

  • GSK Investigational Site

    Atlanta, Georgia, 30341

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Buffalo, New York, 14215

  • GSK Investigational Site

    Cleveland, Ohio, 44106

  • GSK Investigational Site

    Dallas, Texas, 75137

  • GSK Investigational Site

    Duarte, California, 91010

  • GSK Investigational Site

    Hollywood, Florida, 33021

  • GSK Investigational Site

    Honolulu, Hawaii, 96813

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Lawton, Oklahoma, 73505

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    Lubbock, Texas, 79410

  • GSK Investigational Site

    Lubbock, Texas, 79415

  • GSK Investigational Site

    New York, New York, 10029

  • GSK Investigational Site

    New York, New York, 10065

  • GSK Investigational Site

    Portland, Oregon, 97227

  • GSK Investigational Site

    San Francisco, California, 94143

  • GSK Investigational Site

    Savannah, Georgia, 31405

  • GSK Investigational Site

    Seattle, Washington, 98109

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20007

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20010-2975

  • GSK Investigational Site

    Willow Grove, Pennsylvania, 19090

  • GSK Investigational Site

    Worcester, Massachusetts, 01655

Other trials in United States

United Kingdom10 sites

  • GSK Investigational Site

    Leed, LS1 3EX

  • GSK Investigational Site

    London, E1 1BB

  • GSK Investigational Site

    London, NW1 2BU

  • GSK Investigational Site

    London, SE5 9RS

  • GSK Investigational Site

    Manchester, M13 9WL

  • GSK Investigational Site

    Morriston, SA6 6NL

  • GSK Investigational Site

    Plymouth, Devon, PL6 8DH

  • GSK Investigational Site

    Reading, RG1 5AN

  • GSK Investigational Site

    Rhyl, Denbighshire

  • GSK Investigational Site

    Taunton, Somerset, TA1 5DA

Other trials in United Kingdom

Canada8 sites

  • GSK Investigational Site

    Burnaby, British Columbia, V5H 4K7

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • GSK Investigational Site

    Hamilton, Ontario, L8N 3Z5

  • GSK Investigational Site

    Laval, Quebec, H7M 3L9

  • GSK Investigational Site

    Montreal, Quebec, H2L 4M1

  • GSK Investigational Site

    Montreal, Quebec, H3T 1E2

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • GSK Investigational Site

    Weston, Ontario, M9N 1N8

Other trials in Canada

Poland7 sites

  • GSK Investigational Site

    Gdansk, 80-952

  • GSK Investigational Site

    Krakow, 31-501

  • GSK Investigational Site

    Legnica, 59-200

  • GSK Investigational Site

    Opole, 45-372

  • GSK Investigational Site

    Słupsk, 76-200

  • GSK Investigational Site

    Torun, 87-100

  • GSK Investigational Site

    Wroclaw, 50-367

Other trials in Poland

Italy6 sites

  • GSK Investigational Site

    Albano Laziale (Roma), Lazio, 00041

  • GSK Investigational Site

    Bologna, Emilia-Romagna, 40138

  • GSK Investigational Site

    Milan, Lombardy, 20132

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Padova, Veneto, 35128

  • GSK Investigational Site

    Vicenza, Veneto, 36100

Other trials in Italy

Germany5 sites

  • GSK Investigational Site

    Berlin, State of Berlin, 13353

  • GSK Investigational Site

    Giessen, Hesse, 35392

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Munich, Bavaria, 80639

  • GSK Investigational Site

    Saarbrücken, Saarland, 66113

Other trials in Germany

Greece5 sites

  • GSK Investigational Site

    Athens, 10676

  • GSK Investigational Site

    Athens, 11527

  • GSK Investigational Site

    Athens, 15123

  • GSK Investigational Site

    Heraklion, Crete, 71201

  • GSK Investigational Site

    Thessaloniki, 57010

Other trials in Greece

Ukraine5 sites

  • GSK Investigational Site

    Dnipropetrovsk, 49102

  • GSK Investigational Site

    Kyiv, 03150

  • GSK Investigational Site

    Kyiv, 04112

  • GSK Investigational Site

    Lviv, 79044

  • GSK Investigational Site

    Odesa, 65025

Other trials in Ukraine

Czechia4 sites

  • GSK Investigational Site

    Brno, 625 00

  • GSK Investigational Site

    Hradec Králové, 500 05

  • GSK Investigational Site

    Olomouc, 775 20

  • GSK Investigational Site

    Prague, 128 20

Other trials in Czechia

France4 sites

  • GSK Investigational Site

    Bobigny, 93003

  • GSK Investigational Site

    Caen, 14033

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Pessac, 33604

Other trials in France

New Zealand4 sites

  • GSK Investigational Site

    Auckland, 1309

  • GSK Investigational Site

    Auckland, 1701

  • GSK Investigational Site

    Christchurch, 8011

  • GSK Investigational Site

    Grafton, 1003

Other trials in New Zealand

Taiwan4 sites

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 110

  • GSK Investigational Site

    Taipei, 114

  • GSK Investigational Site

    Taipei

Other trials in Taiwan

China3 sites

  • GSK Investigational Site

    Jiang Su Province, 215006

  • GSK Investigational Site

    Shanghai, 200025

  • GSK Investigational Site

    Tianjin, 300020

Other trials in China

Netherlands3 sites

  • GSK Investigational Site

    Amersfoort, 3816 CP

  • GSK Investigational Site

    Nijmegen, 6525 GA

  • GSK Investigational Site

    Zwolle, 8025 AB

Other trials in Netherlands

Russia3 sites

  • GSK Investigational Site

    Moscow, 125167

  • GSK Investigational Site

    Novosibirsk, 630087

  • GSK Investigational Site

    Saint Petersburg, 193024

Other trials in Russia

Slovakia3 sites

  • GSK Investigational Site

    Košice, 041 90

  • GSK Investigational Site

    Martin, 036 59

  • GSK Investigational Site

    Prešov, 080 01

Other trials in Slovakia

Spain3 sites

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Palma de Mallorca, 07014

Other trials in Spain

Tunisia3 sites

  • GSK Investigational Site

    Sfax, 3029

  • GSK Investigational Site

    Sousse, 4000

  • GSK Investigational Site

    Tunis, 1008

Other trials in Tunisia

India2 sites

  • GSK Investigational Site

    Bangalore, 560002

  • GSK Investigational Site

    Manipal, 576 104

Other trials in India

Peru2 sites

  • GSK Investigational Site

    Lima, Lima Province, Lima 41

  • GSK Investigational Site

    Lima, Lima 27

Other trials in Peru

Austria1 site

  • GSK Investigational Site

    Vienna, A-1090

Other trials in Austria

Denmark1 site

  • GSK Investigational Site

    Odense, 5000

Other trials in Denmark

Finland1 site

  • GSK Investigational Site

    Kuopio, 70210

Other trials in Finland

Hong Kong1 site

  • GSK Investigational Site

    Shatin

Other trials in Hong Kong

Vietnam1 site

  • GSK Investigational Site

    Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy, Safety and Tolerability of Eltrombopag Olamine (SB-497115-GR), a Thrombopoietin Receptor Agonist, Administered for 6 Months as Oral Tablets Once Daily in Adult Subjects With Previously Treated Chronic ITP.

The rationale for this Phase III study is to evaluate the 6 month safety and efficacy of eltrombopag in the treatment of previously treated subjects with chronic ITP. The starting dose of eltrombopag, 50 mg, once daily was selected based upon the observed efficacy, safety and pharmacokinetics in a dose-finding Study (TRA100773). This Phase III study is a randomized, double-blind, placebo-controlled, Phase III study, to evaluate efficacy, safety and tolerability of eltrombopag, initially administered as 50 mg oral tablets once daily for six months in adult subjects with previously treated chronic ITP. Subjects will be randomized 2:1, eltrombopag to placebo, and will be stratified based upon splenectomy status, use of ITP medication at baseline and baseline platelet count less than or equal to 15,000/µL. Subjects will receive study medication for 6 months, during which the dose of study medication may be adjusted based upon individual platelet counts. In addition, subjects may taper off concomitant ITP medications and may receive any rescue treatments as dictated by local standard of care. After discontinuation of study medication, subjects will complete follow-up visits at weeks 1, 2, 4 and months 3 and 6.

Read the detailed description

A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP).

Being tested
eltrombopag, Placebo
Keywords
ITP, idiopathic, platelets, purpura, thrombocytopenia, Idiopathic Thrombocytopenic Purpura, thrombocytopenic
Medical subject headings
Purpura, Thrombocytopenia, Purpura, Thrombocytopenic, Idiopathic

What participants receive

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

  • eltrombopagDrug

    Subjects will initiate treatment with either 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down.

  • PlaceboDrug

    Subjects will initiate treatment with either 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down

Study groups in NCT00370331
Study groupRoleWhat they receive
Treatment arm plus standard of careExperimentalSubjects will initiate treatment with 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down.
Receives: Drug: eltrombopag
placebo plus standard of carePlacebo comparatorSubjects will initiate treatment with 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down.
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Responders

    The percentage of evaluable participants who achieved a platelet response (defined as a platelet count between 50,000 and 400,000 microliter) at each nominal on-therapy day and 4 weeks post-treatment

    Measured: Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment

Secondary outcomes (9)

  1. Summary of Median Platelet Counts

    Platelet counts were measured by blood draw.

    Measured: Baseline; Day 8 through Week 26 on-treatment; and 1, 2, 4 week follow-up visits

  2. Percentage of Participants Initiating Rescue Treatment On-therapy

    Percentage of participants initiating new ITP medication, an increased dose of concomitant ITP medication from baseline, platelet transfusion, or splenectomy.

    Measured: Anytime from Day 1 to Week 26

  3. Maximum and Total Weeks of Platelet Response

    Response is defined as a platelet count between 50,000 and 400,000 platelets per microliter.

    Measured: Day 1 through Week 26 on-treatment

  4. Percentage of Participants With a Reduction in Use of Baseline ITP Medication

    Percentage of participants who experienced a reduction in their baseline concomitant ITP medication use

    Measured: From Day 1 through Week 26 on-treatment

  5. WHO Bleeding Scale

    Summary of World Health Organization (WHO) bleeding scores at each nominal visit. WHO Grades 1-4 = any bleeding; WHO Grades 2-4 = clinically significant bleeding

    Measured: Baseline, all nominal visits on-therapy defined as Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Week 10, Week 14, Week 18, Week 22, Week 26, and 1, 2 and 4 week follow-up visits

  6. HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment

    Health-related quality of life (HR-QoL) patient reported outcomes from the short form-36v2 (SF-36v2) questionnaire. Scores could range from 0 (worst possible) to 100 (best possible).

    Measured: Baseline, Week 6, Week 14, and Week 26/Early Withdrawal

  7. HR-QoL Instrument and Domain Scores From the FACIT-F Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment

    Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of chronic illness therapy fatigue (FACIT-F) questionnaire. Scores could range from 0 (worst possible) to 52 (best possible).

    Measured: Baseline, Week 6, Week 14, and Week 26/Early Withdrawal

  8. HR-QoL Instrument and Domain Scores for the FACT-Th Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment

    Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of cancer therapy thrombocytopenia (FACT-Th) questionnaire (six selected items). Scores could range from 0 (worst possible) to 24 (best possible).

    Measured: Baseline, Week 6, Week 14, and Week 26/Early Withdrawal

  9. HR-QoL Instrument and Domain Scores From the MEI-SF Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment

    Health-related quality of life (HR-QoL) patient reported outcomes from the motivation and energy inventory-short form (MEI-SF) questionnaire. Scores could range from 0 (worst possible) to 72 (best possible).

    Measured: Baseline, Week 6, Week 14, and Week 26/Early Withdrawal

Timeline

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

  1. First posted31 Aug 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionJul 2008
  4. Study completionJul 2008

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
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00370331
Sponsor's protocol ID
TRA102537
Acronym
RAISE
Status last verified
Mar 2017
First submitted
29 Aug 2006
Last updated
18 Apr 2017

Publications

  • Cheng G, Saleh MN, Marcher C, Vasey S, Mayer B, Aivado M, Arning M, Stone NL, Bussel JB. Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study. Lancet. 2011 Jan 29;377(9763):393-402. doi: 10.1016/S0140-6736(10)60959-2. Epub 2010 Aug 23.

    PubMed 20739054

  • Haselboeck J, Pabinger I, Ay C, Koder S, Panzer S. Platelet activation and function during eltrombopag treatment in immune thrombocytopenia. Ann Hematol. 2012 Jan;91(1):109-13. doi: 10.1007/s00277-011-1249-5. Epub 2011 May 7.

    PubMed 21553010

  • Hayes S, Ouellet D, Zhang J, Wire MB, Gibiansky E. Population PK/PD modeling of eltrombopag in healthy volunteers and patients with immune thrombocytopenic purpura and optimization of response-guided dosing. J Clin Pharmacol. 2011 Oct;51(10):1403-17. doi: 10.1177/0091270010383019. Epub 2010 Dec 8.

    PubMed 21148042

  • Tarantino MD, Fogarty P, Mayer B, Vasey SY, Brainsky A. Efficacy of eltrombopag in management of bleeding symptoms associated with chronic immune thrombocytopenia. Blood Coagul Fibrinolysis. 2013 Apr;24(3):284-96. doi: 10.1097/MBC.0b013e32835fac99.

    PubMed 23492914

  • Fogarty PF, Tarantino MD, Brainsky A, Signorovitch J, Grotzinger KM. Selective validation of the WHO Bleeding Scale in patients with chronic immune thrombocytopenia. Curr Med Res Opin. 2012 Jan;28(1):79-87. doi: 10.1185/03007995.2011.644849. Epub 2011 Dec 20.

    PubMed 22117897

  • Signorovitch J, Brainsky A, Grotzinger KM. Validation of the FACIT-fatigue subscale, selected items from FACT-thrombocytopenia, and the SF-36v2 in patients with chronic immune thrombocytopenia. Qual Life Res. 2011 Dec;20(10):1737-44. doi: 10.1007/s11136-011-9912-9. Epub 2011 May 1.

    PubMed 21533818

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing eltrombopag in people with Purpura, Thrombocytopaenic, Idiopathic, run by GlaxoSmithKline at 115 sites in 25 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 19 inclusion and 14 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 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, United Kingdom, Canada, Poland, Italy and 20 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. Some participants in this study may receive a placebo. 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 23 Feb 2010). 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?

Percentage of Responders (time frame: Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment). 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 NCT00370331, which also lists 6 linked publications.

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 18 Apr 2017.

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