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A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01098487
First received: March 25, 2010
Last updated: February 7, 2013
Last verified: January 2013

March 25, 2010
February 7, 2013
May 2010
April 2015   (final data collection date for primary outcome measure)
  • The proportion of subjects with presence or absence of bone marrow fibers at baseline and a change from baseline after 1 year treatment. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • The proportion of subjects with presence or absence of bone marrow fibers at baseline and a change from baseline after 2 years of treatment. [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01098487 on ClinicalTrials.gov Archive Site
Safety and tolerability parameters including clinical laboratory tests, and incidents of all adverse events. [ Time Frame: 2 years of treatment ] [ Designated as safety issue: Yes ]
Safety and tolerability parameters including clinical laboratory tests, and incidence of all adverse events. [ Time Frame: 2 year of treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
A Longitudinal 2-year Bone Marrow Study of Eltrombopag Olamine (SB-497115-GR) in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

A open-label, multi-center 2-year safety study to ascertain the baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and to evaluate the long-term effect of eltrombopag on bone marrow fibers. The study will also describe the long-term safety and tolerability of oral eltrombopag treatment in subjects with chronic ITP.

This is a phase IV, open-label safety study, designed to determine baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP)and to evaluate the long-term effect of eltrombopag on bone marrow reticulin and/or collagen fibers.

The duration of the screening period is up to 8 weeks. Eltrombopag will be administered for at least 2-years followed by a 4-week follow-up period. Bone marrow biopsies will be performed at screening, after 1-year and 2-years of eltrombopag treatment, and at early withdrawal of treatment. The screening bone marrow biopsy should be performed within 8 weeks of planned start of study medication and the bone marrow biopsy block must be available for central laboratory processing.

Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Purpura, Thrombocytopenic, Idiopathic
Drug: Eltrombopag olamine
Thrombopoietin receptor agonist
Experimental: Open Label
Oral eltrombopag once daily, starting dose 50 mg (or 25 mg for subjects of East Asian ancestry).
Intervention: Drug: Eltrombopag olamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
May 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have signed and dated a written informed consent and be able to understand and comply with protocol requirements and instructions.
  • 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; Provan, 2009]. In addition, a peripheral blood smear should support the diagnosis of ITP with no evidence of other disease causative of thrombocytopenia (e.g., pseudo thrombocytopenia, myelofibrosis). The physical examination should not suggest any disease, which may cause thrombocytopenia other than ITP.
  • Subjects must be physically eligible for serial bone marrow biopsies and must have a bone marrow biopsy performed during screening, and be willing to remain on the study for at least 2 years with annual bone marrow biopsies.
  • Subjects, who previously received eltrombopag or romiplostim, must have completed treatment with these therapies at least 6 months prior to the screening bone marrow biopsy.
  • Subjects must have the following clinical chemistry values:
  • ALT and AST < 2xULN;
  • Bilirubin <1.5xULN (except for Gilbert's Syndrome);
  • Subjects are practicing an acceptable method of contraception as specified in the protocol.
  • In France, subjects will be eligible for inclusion in this study, only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

  • Subjects with any clinically relevant abnormality, other than ITP, 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).
  • Subjects with any concurrent malignant disease and/or a recent history of cancer treatment with systemic chemotherapy and/or radiotherapy.

Exception: Subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.

  • Subjects with 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, hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, etc), or any family history of arterial or venous thrombosis.
  • Subjects with screening bone marrow fibers of either MF Grade 3 using European Consensus scale or Grade 4 using Bauermeister scale.
  • Subjects with a QTc >450 msec or > 480 msec for subjects with Bundle Branch Block.
  • Female subjects who are nursing or pregnant (positive serum or urine β-human chorionic gonadotrophin (β-hCG) pregnancy test) at screening.
  • Subjects treated with an investigational drug (other than a thrombopopoetin-receptor (TPO-R) agonist) within 30 days or five half-lives (whichever is longer) preceding the first dose of eltrombopag in the study. (For romiplostim or eltrombopag, see inclusion criterion #4).
  • Subjects treated with any TPO-R agonist other than romiplostim or eltrombopag.
  • Subjects with recent history of alcohol/drug abuse as determined by the investigator.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   France,   Germany,   Hong Kong,   Hungary,   India,   Italy,   Korea, Republic of,   Pakistan,   Russian Federation
 
NCT01098487
112940
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP