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Idiopathic Thrombocytopenic PurpuraPhase 3NCT00828750

Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)

A Phase 3 study testing Eltrombopag oral tablets in people with Idiopathic Thrombocytopenic Purpura and Purpura, Thrombocytopenic, Idiopathic, run by GlaxoSmithKline at 6 sites in Japan.

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

An open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for treatment of subjects with ITP who have previously been enrolled in the eltrombopag trial TRA108109 (NCT00540423). Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Eltrombopag oral tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
6 sitesJapan
Study dates
May 2008to Feb 2011
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has signed and dated written informed consent.
  • Subject (>=20 years) diagnosed with ITP.
  • Subject previously enrolled in TRA108109 (NCT00540423) must have completed the treatment and follow-up periods as defined in that protocol.
  • Subject has no intercurrent medical event at risk of thrombosis such as thrombophilia.
  • Prolongation of prothrombin time and activated partial thromboplastin time (aPTT) must be within 1.2 times the upper limit of the normal range with no history of hypercoagulable state.
  • A complete blood count (CBC), within the reference range, with the following exceptions:
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  • Hemoglobin: patients with haemoglobin level < the lower limit of normal are eligible for inclusion if hemorrhage is present.
  • Neutrophil count >= 1,500/L (1.5x10E9/L) is required for inclusion.
  • The following clinical chemistries MUST NOT exceed 1.2 times the upper limit of the normal reference range: creatinine, total bilirubin and alkaline phosphatase.
  • The following clinical chemistries MUST NOT exceed 2 times the upper limit of the normal reference range: ALT and AST.
  • Albumin must be not less than 80% of the lower limit of normal.
  • Female subjects must either be:
  • of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or
  • of childbearing potential and have a negative pregnancy test and agree to use contraceptive methods specified in the GSK List of Highly Effective Methods for Avoidance of Pregnancy from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study:
  • Reticulocyte count within the reference range or elevated in case of bleeding.

Who cannot join

  • Any severe medical condition (cardiac, hepatic or renal disorder) other than chronic ITP. (Note: "Severe" is defined as >= Grade 3 as a rule according to the "Classification of the Severity of Adverse Experiences (PAB/SD Notification No.80, dated 29 June 1992)
  • History of suspected or confirmed arterial or venous thrombosis (e.g., myocardial infarction, deep vein thrombosis) within the last 1 year.
  • History of drug/alcohol abuse or dependence within the last 1 year.
  • Suspected blood disorder other than ITP.
  • Suspected platelet aggregation abnormality.
  • Suspected cyclic thrombocytopenia.
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  • Suspected Evans Syndrome.
  • Subjects who met the GSK Liver Stopping Criteria in the previous eltrombopag study TRA108109 (NCT00540423).
  • Current or history of HIV infection or hepatitis B virus or hepatitis C virus infections.
  • Current malignancy or history of malignancy that was treated with chemotherapy or radiotherapy.
  • Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
  • Subjects who are deemed unsuitable for the study by the investigator (or subinvestigator).
  • Treatment with an investigational drug within 30 days preceding the first dose of study medication.
  • Pre-existing cardiovascular disease, or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation).

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Japan6 sites

  • GSK Investigational Site

    Gifu, 503-8502

  • GSK Investigational Site

    Hiroshima, 734-8551

  • GSK Investigational Site

    Ibaraki, 305-8576

  • GSK Investigational Site

    Osaka, 565-0871

  • GSK Investigational Site

    Osaka, 596-8501

  • GSK Investigational Site

    Tokyo, 160-8582

Other trials in Japan

About this study

Official title: Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)-An Extension Study of Eltrombopag in Subjects, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study TRA108109 (NCT00540423)-<Phase III Study>

An open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for treatment of subjects with ITP who have previously been enrolled in the eltrombopag trial TRA108109 (NCT00540423).

Being tested
Eltrombopag oral tablets
Keywords
eltrombopag, thrombopoietin receptor agonist, ITP, blood platelet
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.

  • Eltrombopag oral tabletsDrug

    Also called SB-497115-GR oral tablets

    Eltrombopag oral tablets once daily

Study groups in NCT00828750
Study groupRoleWhat they receive
TreatmentExperimentalEltrombopag oral tablets once daily
Receives: Drug: Eltrombopag oral tablets

What is being measured

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

  1. Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment.

    Measured: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)

Secondary outcomes (7)

  1. Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L

    Platelet counts were measured by blood draw.

    Measured: Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)

  2. Median Platelet Counts

    Platelet counts were measured by blood draw.

    Measured: Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)

  3. Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)

    Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.

    Measured: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)

  4. Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals

    Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.

    Measured: 3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks)

  5. Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication

    Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s).

    Measured: Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)

  6. Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication

    Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration.

    Measured: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)

  7. Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy

    Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy.

    Measured: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)

Timeline

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

  1. First posted26 Jan 2009 (estimated)
  2. Study startMay 2008
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00828750
Sponsor's protocol ID
111433
Status last verified
Oct 2011
First submitted
22 Jan 2009
Last updated
17 Sep 2018

Publications

  • Katsutani S, Tomiyama Y, Kimura A, Miyakawa Y, Okamoto S, Okoshi Y, Ninomiya H, Kosugi H, Ishii K, Ikeda Y, Hattori T, Katsura K, Kanakura Y. Oral eltrombopag for up to three years is safe and well-tolerated in Japanese patients with previously treated chronic immune thrombocytopenia: an open-label, extension study. Int J Hematol. 2013 Sep;98(3):323-30. doi: 10.1007/s12185-013-1401-1. Epub 2013 Jul 30.

    PubMed 23896965

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eltrombopag oral tablets in people with Idiopathic Thrombocytopenic Purpura and Purpura, Thrombocytopenic, Idiopathic, run by GlaxoSmithKline at 6 sites in Japan.

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 15 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 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. 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 1 Dec 2011). 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 Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category (time frame: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)). 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 NCT00828750, 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 17 Sep 2018.

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