NCT00828750

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2008

Typical duration for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
10 months until next milestone

Results Posted

Study results publicly available

December 1, 2011

Completed
Last Updated

September 17, 2018

Status Verified

October 1, 2011

Enrollment Period

2.8 years

First QC Date

January 22, 2009

Results QC Date

September 15, 2011

Last Update Submit

September 13, 2018

Conditions

Idiopathic Thrombocytopenic PurpuraPurpura, Thrombocytopenic, Idiopathic

Keywords

eltrombopagthrombopoietin receptor agonistITPblood platelet

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (7)

  • 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

    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)

  • Median Platelet Counts

    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)

  • 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.)

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

  • 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

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

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

    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 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Eltrombopag oral tablets once daily

Drug: Eltrombopag oral tablets

Interventions

Eltrombopag oral tabletsDRUG

Eltrombopag oral tablets once daily

Also known as: SB-497115-GR oral tablets
Treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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.

You may not qualify if:

  • 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.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

GSK Investigational Site

Gifu, 503-8502, Japan

Location

GSK Investigational Site

Hiroshima, 734-8551, Japan

Location

GSK Investigational Site

Ibaraki, 305-8576, Japan

Location

GSK Investigational Site

Osaka, 565-0871, Japan

Location

GSK Investigational Site

Osaka, 596-8501, Japan

Location

GSK Investigational Site

Tokyo, 160-8582, Japan

Location

Related Publications (1)

  • 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.

    PMID: 23896965DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 26, 2009

Study Start

May 1, 2008

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

September 17, 2018

Results First Posted

December 1, 2011

Record last verified: 2011-10

Locations

JP(6)