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eltrombopag 12.5 milligrams

Phase 2

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

eltrombopag 12.5 milligrams target and mechanism

Molecular targetMPL
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

eltrombopag 12.5 milligrams clinical trials

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 DiseasesUnlock trial analytics

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?

Eltrombopag 12.5 milligrams is a low-dose tablet formulation of eltrombopag, a small molecule drug developed by GSK plc (ticker GSK). It is being studied in liver diseases, specifically in thrombocytopenic patients with chronic liver disease. The 12.5 mg strength is also referred to as the eltrombopag 12.5 mg tablet.

What is eltrombopag 12.5 milligrams used for in liver diseases?

Eltrombopag 12.5 milligrams has been studied in thrombocytopenic patients with chronic liver disease. A Phase 2 pharmacokinetics trial evaluated the drug in this population in Japan. The condition studied was liver diseases, and the trial enrolled 38 subjects aged 20 years and older.

What does eltrombopag 12.5 milligrams target?

Eltrombopag 12.5 milligrams targets MPL, the thrombopoietin receptor. It acts as an MPL agonist, meaning it stimulates that receptor. This target class, agonist activity at MPL, is the basis for its study in thrombocytopenic patients with chronic liver disease.

Who makes eltrombopag 12.5 milligrams?

Eltrombopag 12.5 milligrams is developed by GSK plc, which trades under the ticker GSK. GSK is the company associated with this low-dose eltrombopag tablet and the clinical program in liver diseases.

What phase is eltrombopag 12.5 milligrams in?

Eltrombopag 12.5 milligrams is in Phase 2 development. The single recorded trial, NCT00861601, is a completed Phase 2 pharmacokinetics study. It is an investigational asset in the clinical development stage for liver diseases, and no approval status is established by the available program information.

What clinical trials is eltrombopag 12.5 milligrams in?

Eltrombopag 12.5 milligrams has been evaluated in one clinical trial, NCT00861601, titled a Phase 2 pharmacokinetics study of eltrombopag in Japanese thrombocytopenic subjects with chronic liver disease. That trial is completed, enrolled 38 participants, was randomized and controlled, and was conducted in Japan.