Last updated: 11/03/2018 13:53:47
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
A longitudinal 2-year bone marrow study of eltrombopag in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP)
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with bone marrow (BM) fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) scale at Baseline
Timeframe: Baseline
Number of participants with a positive or negative collagen level at Baseline
Timeframe: Baseline
Number of participants with indicated grade change from Baseline in the EC grading scale at 1 year
Timeframe: Baseline and 1 year
Number of participants with indicated change from Baseline in the EC grading scale at 2 years
Timeframe: Baseline and 2 years
Number of participants with a positive or negative collagen level at 1 year
Timeframe: 1 year
Number of participants with a positive or negative collagen level at 2 year
Timeframe: 2 years
Secondary outcomes:
Number of participants with the indicated maximum toxicity grade for the indicated clinical chemistry parameters at any time post-Baseline during the study
Timeframe: From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)
Number of participants with the indicated maximum toxicity grade for the indicated hematology parameters at any time post-Baseline during the study
Timeframe: From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)
Number of participants with any adverse event (AE) or serious adverse event (SAE) started on-therapy + 1 day, >1 to 30 days post therapy and >30 days post therapy
Timeframe: From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)
Interventions:
Drug: Eltrombopag olamine
Enrollment:
167
Observational study model:
Not applicable
Primary completion date:
2014-06-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Purpura, Thrombocytopaenic, Idiopathic
Product
eltrombopag
Collaborators
Not applicable
Study date(s)
May 2010 to May 2014
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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 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.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Pune, India, 411004
89.3 miles (142.9 km) away from your location
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
No longer a GSK study
Actual primary completion date
2014-06-05
Actual study completion date
2014-06-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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Access to clinical trial data by researchers
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