A Rollover Study to Provide Continued Treatment With Eltrombopag
Condition: Thrombocytopaenia
MeSH terms: Thrombocytopenia
Intervention: Eltrombopag (ELT)
Intervention description: Subjects were dosed with ELT tablets or powder for oral suspension (PfOS) based on the dosage form used in the parent study. ELT tablets were white, round film coated tablets containing ELT olamine equivalent to 12.5 mg, 25 mg, 50 mg, 75 mg and 100 mg of ELT. ELT PfOS was a reddish-brown to yellow powder contained inside an elongated sachet. Each sachet contained ELT olamine equivalent to 20 mg of ELT per gram of powder.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: myelodysplastic syndromes; thrombocytopenia; acute myeloid leukemia; idiopathic thrombocytopenic purpura; Eltrombopag; pediatrics

Summary:

      The objective of this study was to provide continued treatment with eltrombopag for subjects
      who were participating in a Novartis-sponsored investigational study with eltrombopag (parent
      studies 114968/ASPIRE (NCT01440374), PMA112509 (NCT00903422), and TRA105325/EXTEND
      (NCT00351468), receiving clinical benefit without unacceptable toxicity and to collect
      long-term safety data.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent has been obtained from the subject (or subject's legally
             acceptable representative) prior to performance of any study-specific procedure.

          -  The subject is participating in a GSK sponsored investigational study of eltrombopag
             (parent study) within the past 28 days and is receiving clinical benefit without
             unacceptable toxicity as determined by the investigator.

          -  Subjects with a QTc <450 millisecond (msec) or <480 msec for subjects with bundle
             branch block. The QTc is the QT interval corrected for heart rate according to either
             Bazett's formula (QTcB), Fridericia's formula (QTcF) or another method, machine or
             manual overread. For subject eligibility and withdrawal QTcF will be used. For
             purposes of data analysis, QTcF will be used. The QTc should be based on single or
             averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief
             recording period.

          -  Women must be either of non-child bearing potential or women with child-bearing
             potential and men with reproductive potential must be willing to practice acceptable
             methods of birth control during the study.

          -  Women of childbearing potential must have a negative serum pregnancy test within 14
             days of the first dose of study treatment and agree to use effective contraception,
             during the study and for 4 weeks following the last dose of study treatment.

          -  Men with a female partner of childbearing potential must have either had a prior
             vasectomy or agree to use effective contraception from time of first dose until 16
             weeks after the last dose of study treatment.

          -  In France, a subject will be eligible for inclusion in this study only if either
             affiliated to, or a beneficiary of, a social security category.

        Exclusion Criteria:

          -  Permanent discontinuation of eltrombopag in the parent study based upon the study
             treatment discontinuation or study withdrawal criteria from the parent study. Subjects
             who permanently discontinued treatment because they completed all study related
             treatments remain eligible.

          -  The subject is pregnant or a lactating female.

          -  Any serious and/or unstable pre-existing medical, psychiatric disorder or other
             conditions at the time of transition to this study that could interfere with subject's
             safety, obtaining informed consent or compliance with the study procedures, in the
             opinion of the investigator or GSK Medical Monitor.

          -  French subjects: The French subject has participated in any study using an
             investigational drug during the previous 30 days, with the exception of eltrombopag,
             in the parent study.