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eltrombopag 12.5 milligrams

Phase 2

Liver Diseases | Small molecule | Gastrointestinal |GSK plc|Last Updated: May 12, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

eltrombopag 12.5 milligrams · 1 trial · 1 indication

Phase 2 1
NCT00861601Phase 2, Pharmacokinetics Study of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver DiseaseLiver Diseases
COMPLETED38 Analytics
PHASE2COMPLETED
Phase 2, Pharmacokinetics Study of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver Disease
Liver Diseases
NCT0086160138
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Study Endpoints

Primary Endpoints

Change From Baseline in Platelet Counts on Day 15
Baseline, Day 15

Platelet counts were measured by blood draw. Change from Baseline was calculated as the Day 15 value minus the Baseline value.

Secondary Endpoints

Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline Platelet Counts as Covariate)
Baseline, Day 15
Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline of Platelet Counts and Child-Pugh Class as Covariates)
Baseline, Day 15
Percent Change From Baseline in Platelet Counts on Day 15
Baseline, Day 15
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
low doseEXPERIMENTALeltrombopag 12.5 mg/day
middle doseEXPERIMENTALeltrombopag 25 mg/day
high doseEXPERIMENTALeltrombopag 37.5 mg/day

Interventions

NameTypeDescription
eltrombopag 12.5 milligrams (mg) tabletDRUGeltrombopag 12.5 mg tablet once a day
eltrombopag 25 mg tabletDRUGeltrombopag 25 mg tablet once a day
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Subject who agree to comply with protocol requirements and instructions and who provide signed and dated written informed consent. * Male and female subjects, ≥20 years of age (at the time of informed consent) with chronic liver disease. * Child-Pugh score \<=9. * A baseline p...

Countries:Japan
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Frequently asked questions about eltrombopag 12.5 milligrams

What is eltrombopag 12.5 milligrams used for?

Eltrombopag 12.5 milligrams is an investigational small molecule being studied for use in liver diseases, specifically in patients with chronic liver disease who have thrombocytopenia. It is being developed by GSK plc (ticker: GSK) and is currently in Phase 2 clinical development.

Who makes eltrombopag 12.5 milligrams?

Eltrombopag 12.5 milligrams is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 2 clinical trials for the treatment of liver diseases.

What phase is eltrombopag 12.5 milligrams in?

Eltrombopag 12.5 milligrams is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for its safety and efficacy in patients with liver diseases.

What clinical trials is eltrombopag 12.5 milligrams in?

Eltrombopag 12.5 milligrams has one completed clinical trial, identified as NCT00861601. This was a Phase 2 pharmacokinetics study conducted in Japan involving 38 thrombocytopenic subjects with chronic liver disease. The trial was controlled but not double-blinded, and enrolled adults aged 20 years and older.

Is eltrombopag 12.5 milligrams the same as eltrombopag?

Eltrombopag 12.5 milligrams is a specific dosage strength of the drug eltrombopag. The clinical trial NCT00861601 studied this dose in Japanese patients with chronic liver disease and thrombocytopenia. The drug is being developed by GSK plc under the ticker GSK.