NCT00861601

Brief Summary

This is an open label, multi-centre, dose ranging study to assess efficacy, safety and pharmacokinetics of eltrombopag in thrombocytopenic subjects with chronic liver disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

10 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

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 23, 2010

Completed
Last Updated

May 12, 2015

Status Verified

February 1, 2011

Enrollment Period

7 months

First QC Date

March 5, 2009

Results QC Date

May 11, 2010

Last Update Submit

April 23, 2015

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Platelet Counts on Day 15

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

    Baseline, Day 15

Secondary Outcomes (16)

  • 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

  • Platelet Counts by Treatment Visit

    Day 1 (Baseline), Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22)

  • Platelet Counts by Post-Treatment Visit

    4 days post-treatment, 8 days post-treatment, and 15 days post-treatment

  • +11 more secondary outcomes

Study Arms (3)

low dose

EXPERIMENTAL

eltrombopag 12.5 mg/day

Drug: eltrombopag 12.5 milligrams (mg) tablet

middle dose

EXPERIMENTAL

eltrombopag 25 mg/day

Drug: eltrombopag 25 mg tablet

high dose

EXPERIMENTAL

eltrombopag 37.5 mg/day

Drug: eltrombopag 12.5 milligrams (mg) tabletDrug: eltrombopag 25 mg tablet

Interventions

eltrombopag 12.5 milligrams (mg) tabletDRUG

eltrombopag 12.5 mg tablet once a day

high doselow dose
eltrombopag 25 mg tabletDRUG

eltrombopag 25 mg tablet once a day

high dosemiddle dose

Eligibility Criteria

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

You may qualify if:

  • 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 platelet count \<50,000/mcL.
  • A baseline serum sodium level \>130 mEq/L.
  • Haemoglobin concentration \>8 g/dL, stable for at least 4 weeks.
  • A female is eligible to enter and participate in the study if she is of:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who:
  • Has had a hysterectomy
  • Has had a bilateral oophorectomy (ovariectomy)
  • Has had a bilateral tubal ligation
  • Is post-menopausal (demonstrate total cessation of menses for longer than one year)
  • Childbearing potential, has a negative urine and/or serum pregnancy test at screening, and within the 24 hour period prior to the first dose of investigational product and uses one of the following acceptable methods of contraception:
  • Complete abstinence from intercourse.
  • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year.
  • +4 more criteria

You may not qualify if:

  • Subjects with known or suspected hypersensitivity, intolerance or allergy to any of the ingredients in eltrombopag tablets.
  • Evidence of portal vein thrombosis on abdominal imaging (ultrasound with Doppler or appropriate magnetic resonance imaging/computed tomography (MRI/CT) imaging techniques) within 3 months before the start of the study.
  • History of arterial or venous thrombosis (including Budd-Chiari Syndrome),
  • AND ≥ two of the following risk factors:
  • hereditary thrombophilic disorders (e.g. antithrombinIII (ATIII) deficiency, etc.)
  • hormone replacement therapy
  • systemic contraception therapy (containing oestrogen)
  • smoking
  • diabetes
  • hypercholesterolemia
  • medication for hypertension or cancer
  • Human Immunodeficiency Virus (HIV) infection.
  • History of drug/alcohol abuse or dependence within 1 year prior to screening.
  • Any disease condition associated with current active World Health Organization (WHO) Grade 3 or 4 bleeding.
  • Active infection requiring systemic antibiotic therapy.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

GSK Investigational Site

Fukuoka, 810-8563, Japan

Location

GSK Investigational Site

Fukuoka, 814-0180, Japan

Location

GSK Investigational Site

Fukuoka, 815-8555, Japan

Location

GSK Investigational Site

Fukuoka, 830-0011, Japan

Location

GSK Investigational Site

Fukuoka, 839-0863, Japan

Location

GSK Investigational Site

Kagoshima, 890-8520, Japan

Location

GSK Investigational Site

Kumamoto, 860-8556, Japan

Location

GSK Investigational Site

Kumamoto, 862-8655, Japan

Location

GSK Investigational Site

Nagasaki, 856-8562, Japan

Location

GSK Investigational Site

Ōita, 879-5593, Japan

Location

Related Publications (1)

  • Kawaguchi T, Komori A, Seike M, Fujiyama S, Watanabe H, Tanaka M, Sakisaka S, Nakamuta M, Sasaki Y, Oketani M, Hattori T, Katsura K, Sata M. Efficacy and safety of eltrombopag in Japanese patients with chronic liver disease and thrombocytopenia: a randomized, open-label, phase II study. J Gastroenterol. 2012 Dec;47(12):1342-51. doi: 10.1007/s00535-012-0600-5. Epub 2012 Jun 8.

    PMID: 22674141BACKGROUND

MeSH Terms

Conditions

Liver Diseases

Interventions

Tabletseltrombopag

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

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 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 13, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

May 12, 2015

Results First Posted

September 23, 2010

Record last verified: 2011-02

Locations

JP(10)