Last updated: 11/03/2018 20:21:17
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 GSK Clinical Study Register is no longer maintained for this study.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.

An extension study of eltrombopag in pediatric patients with chronic immune (idiopathic) thrombocytopenia purpura (ITP)

GSK study ID
117366
Clinicaltrials.gov ID
NCT02201290
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An extension study of eltrombopag in pediatric patients with chronic immune (idiopathic) thrombocytopenia purpura (ITP)
Trial description: This is an open-label Phase III extension study to evaluate the long-term safety of eltrombopag in pediatric patients with chronic ITP who previously participated in study TRA115450. This study will allow dosing of eltrombopag at an individualized dose for each subject based upon platelet count. The starting dose will be based on the subject’s dose at the end of the TRA115450 study. The maximum dose will be 75 mg daily.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
N\A
Primary outcomes:

Frequency of all adverse events ( including Ophthalmic events) categorized using CTCAE toxicity grades and clinical laboratory test

Timeframe: Up to Week 4 Follow-up period

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Eltrombopag Tablets
  • Drug: Eltrombopag PfOS
    • Enrollment:
    10
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Purpura, Thrombocytopenic, Idiopathic
    Product
    eltrombopag
    Collaborators
    Not applicable
    Study date(s)
    June 2013 to April 2019
    Type
    Interventional
    Phase
    2/3

    Participation criteria

    Sex
    Female & Male
    Age
    1 - 17 Year
    Accepts healthy volunteers
    none
    • Written informed consent must be obtained from the subject’s guardian and accompanying informed assent from the subject (for children over 6 years old).
    • Subjects must be between 1 year and <18 years of age at Day 1.
    • Subjects with any clinically relevant abnormality, other than ITP, identified on the screening examination 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).
    • Any subject considered to be a child in care, defined as one who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. This can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or who has an appointed legal guardian.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Written informed consent must be obtained from the subject’s guardian and accompanying informed assent from the subject (for children over 6 years old).
    • Subjects must be between 1 year and <18 years of age at Day 1.
    • Subjects must have enrolled in TRA115450/PETIT2 study.
    • Subjects must have completed Part 1 and Part 2 of TRA115450/PETIT2 study.
    • Female subjects of child-bearing potential (after menarche) must have a negative pregnancy test within 24 hours of first dose of study treatment; agree and be able to provide a blood or urine specimen for pregnancy testing during the study; agree to use effective contraception during the study and for 28 days following the last dose of study treatment, and not be lactating.
    • Male subjects with a female partner of childbearing potential must agree to use effective contraception from 2 weeks prior to administration of the first dose of study treatment until 3 months after the last dose of study treatment.
    Exclusion criteria:
    • Subjects with any clinically relevant abnormality, other than ITP, identified on the screening examination 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).
    • Any subject considered to be a child in care, defined as one who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. This can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or who has an appointed legal guardian.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    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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