Phase
Condition
Lupus
Thrombocytopenic
Immune Thrombocytopenia (Itp)
Treatment
N/AClinical Study ID
Ages 1-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent must be obtained from the patient's guardian and accompanyinginformed assent from the patient (for children over 6 years old)
Patients must be between 1 year and <18 years of age at Day 1
Patients will have a confirmed diagnosis of chronic ITP for at least 1 year, atscreening, according to the guidelines published in the International Working GroupReport
A peripheral blood smear or bone marrow examination will support the diagnosis of ITPwith no evidence of other causes of thrombocytopenia.
Patients must be refractory or have relapsed after at least one prior ITP therapy, orpatients must be unable, for a medical reason, to continue other ITP treatments.
Patients must have a Day 1 (or within 48 hours prior) platelet count <30 Gi/L.
Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have beencompleted at least 2 weeks prior to Day 1, or these therapies must have been completedat least 1 week prior to Day 1 and have been clearly ineffective.
Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must havebeen completed at least 4 weeks prior to Day 1.
Patients treated with concomitant ITP medication (e.g. corticosteroids orazathioprine) must be receiving a dose that has been stable for at least 4 weeks priorto Day 1.
Patients must have a complete blood count (CBC) not suggestive of anotherhematological disorder.
Patients must have the following laboratory results:
prothrombin time international normalized ratio (INR) and activated partialthromboplastin time (aPTT) within 80 to 120% of the normal range.
clinical chemistries that do NOT exceed the upper limit of normal reference range bymore than 20% for the following: creatinine, ALT, AST, total bilirubin, and alkalinephosphatase.
total albumin that is not below the lower limit of normal by more than 10%.
Female patients 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 duringthe study,
agree to use effective contraception during the study and for 28 days following thelast dose of study treatment, and not be lactating.
Male patients with a female partner of childbearing potential must agree to useeffective contraception from 2 weeks prior to administration of the first dose ofstudy treatment until 3 months after the last dose of study treatment.
In France, a patient will be eligible for inclusion in this study only if eitheraffiliated to or a beneficiary of a social security category.
Exclusion
Exclusion Criteria:
Patients with any clinically relevant abnormality, other than ITP, identified on thescreening examination or any other medical condition or circumstance, which in theopinion of the investigator makes the patient unsuitable for participation in thestudy or suggests another primary diagnosis (e.g. Thrombocytopenia is secondary toanother disease).
Patients with concurrent or past malignant disease, including myeloproliferativedisorder.
Patients expected not to be suitable for continuation of their current therapy for atleast 13 additional weeks.
Patients with a history of platelet agglutination abnormality that prevents reliablemeasurement of platelet counts.
Patients with a diagnosis of secondary immune thrombocytopenia, including those withlaboratory or clinical evidence of HIV infection, anti-phospholipid antibody syndrome,chronic hepatitis B infection, hepatitis c virus infection, or any evidence of activehepatitis at the time of subject screening.
Patients with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis).
Patients with known inherited thrombocytopenia (e.g. MYH9 disorders).
Patients treated with any medication that affects platelet function (including but notlimited to aspirin, clopidogrel and/or NSAIDS) or anti-coagulants for >3 consecutivedays within 2 weeks of Day 1.
Patients who have received treatment with an investigational drug within 30 days or 5half-lives (whichever is longer) preceding Day 1.
Patients who have previously received eltrombopag or any other thrombopoietin receptoragonist.
Any patient considered to be a child in care, defined as one who has been placed underthe control or protection of an agency, organization, institution or entity by thecourts, the government or a government body, acting in accordance with powersconferred on them by law or regulation. This can include a child cared for by fosterparents or living in a care home or institution, provided that the arrangement fallswithin the definition above. The definition of a child in care does not include achild who is adopted or who has an appointed legal guardian.
Patients who have a known immediate or delayed hypersensitivity reaction oridiosyncrasy to drugs chemically related to eltrombopag or excipients thatcontraindicates their participation.
Any serious and/or unstable pre-existing medical, psychiatric disorder, or otherconditions that could interfere with the patient's safety or compliance to the studyprocedures.
Study Design
Study Description
Connect with a study center
GSK Investigational Site
Capital Federal, Buenos Aires 1425
ArgentinaSite Not Available
GSK Investigational Site
Santiago, 8380418
ChileSite Not Available
GSK Investigational Site
Brno, 613 00
Czech RepublicSite Not Available
GSK Investigational Site
Olomouc, 775 20
Czech RepublicSite Not Available
GSK Investigational Site
Ostrava, 708 52
Czech RepublicSite Not Available
GSK Investigational Site
Praha 5, 154 00
Czech RepublicSite Not Available
GSK Investigational Site
Freiburg, Baden-Wuerttemberg 79106
GermanySite Not Available
GSK Investigational Site
Mainz, Rheinland-Pfalz 55131
GermanySite Not Available
GSK Investigational Site
Berlin, 13353
GermanySite Not Available
GSK Investigational Site
Pokfulam,
Hong KongSite Not Available
GSK Investigational Site
Shatin,
Hong KongSite Not Available
GSK Investigational Site
Beer-Sheva, 84101
IsraelSite Not Available
GSK Investigational Site
Haifa, 31048
IsraelSite Not Available
GSK Investigational Site
Petah-Tikva, 49202
IsraelSite Not Available
GSK Investigational Site
Ramat Gan, 52621
IsraelSite Not Available
GSK Investigational Site
Rehovot, 76100
IsraelSite Not Available
GSK Investigational Site
Tel-Aviv, 64239
IsraelSite Not Available
GSK Investigational Site
Bologna, Emilia-Romagna 40138
ItalySite Not Available
GSK Investigational Site
Roma, Lazio 00165
ItalySite Not Available
GSK Investigational Site
Monza, Lombardia 20900
ItalySite Not Available
GSK Investigational Site
Pavia, Lombardia 27100
ItalySite Not Available
GSK Investigational Site
Torino, Piemonte 10126
ItalySite Not Available
GSK Investigational Site
Bari, Puglia 70124
ItalySite Not Available
GSK Investigational Site
Padova, Veneto 35128
ItalySite Not Available
GSK Investigational Site
Bydgoszcz,
PolandSite Not Available
GSK Investigational Site
Gdansk, 80-952
PolandSite Not Available
GSK Investigational Site
Lodz, 91-738
PolandSite Not Available
GSK Investigational Site
Lublin, 20-093
PolandSite Not Available
GSK Investigational Site
Zabrze, 41-800
PolandSite Not Available
GSK Investigational Site
Krasnodar, 350007
Russian FederationSite Not Available
GSK Investigational Site
Moscow, 117198
Russian FederationSite Not Available
GSK Investigational Site
Saint Petersburg, 198205
Russian FederationSite Not Available
GSK Investigational Site
Barcelona, 08035
SpainSite Not Available
GSK Investigational Site
Madrid, 28007
SpainSite Not Available
GSK Investigational Site
Murcia (El Palmar), 30120
SpainSite Not Available
GSK Investigational Site
Málaga, 29011
SpainSite Not Available
GSK Investigational Site
Málaga, 29011
SpainSite Not Available
GSK Investigational Site
Pamplona, 31008
SpainSite Not Available
GSK Investigational Site
Valencia, 46026
SpainSite Not Available
GSK Investigational Site
Tainan, 704
TaiwanSite Not Available
GSK Investigational Site
Taoyuan, 333
TaiwanSite Not Available
GSK Investigational Site
Bangkok,
ThailandSite Not Available
GSK Investigational Site
Khon Kaen, 40002
ThailandSite Not Available
GSK Investigational Site
Songkla, 90110
ThailandSite Not Available
GSK Investigational Site
Birmingham, B4 6NH
United KingdomSite Not Available
GSK Investigational Site
Cardiff, CF14 4XW
United KingdomSite Not Available
GSK Investigational Site
London, SW17 0QT
United KingdomSite Not Available
GSK Investigational Site
Manchester, M13 9WL
United KingdomSite Not Available
GSK Investigational Site
Romford, RM7 0AG
United KingdomSite Not Available
GSK Investigational Site
Sheffield, S10 2TH
United KingdomSite Not Available
GSK Investigational Site
Los Angeles, California 90027
United StatesSite Not Available
GSK Investigational Site
St. Petersburg, Florida 33701
United StatesSite Not Available
GSK Investigational Site
Brooklyn, New York 11219
United StatesSite Not Available
GSK Investigational Site
Salt Lake City, Utah 84113
United StatesSite Not Available
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