An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytop… (NCT01129024) | Clinical Trial Compass
TerminatedPhase 2
An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytopenia (ITP)
Stopped: The study was terminated due to cessation of clinical development of S-888711 for chronic ITP based on a business decision by the Sponsor.
United States19 participantsStarted 2010-04-29
Plain-language summary
The primary objective of this study was to assess the long-term safety of lusutrombopag in the treatment of adults with relapsed persistent or chronic ITP with or without prior splenectomy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects who previously participated in Study 0913M0621 (NCT01054443) and who completed treatment or discontinued treatment due to a platelet count \> 400,000/μL and continued to meet all inclusion criteria of the previous study, listed below, including platelet counts \< 50,000/μL were eligible for study participation. For the purpose of this study, initial screening visit and all prestudy time period refer to Study 0913M0621.
* A signed and dated written informed consent
* Males and females ≥ 18 years of age
* All subjects must agree to use barrier contraception
* Diagnosis of ITP
* Subjects \> 60 years must have had a diagnostic bone marrow aspiration
* Relapsed persistent or chronic ITP status, with or without prior splenectomy
* Subjects receiving steroid therapy must be on a stable dose for at least 2 weeks prior to Screening
* Prothrombin time (PT) and activated partial thromboplastin time (aPTT) within 20% of the upper limit of normal (ULN) at Screening
* Subjects receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine, or danazol are allowed
Exclusion Criteria:
* History of clinically important hemorrhagic clotting disorder
* Females who are pregnant, lactating, or taking oral contraceptives
* History of alcohol/drug abuse or dependence within 1 year
* Use of the following drugs or treatment prior to Visit 1 (Day 1):
* Within 1 week - Rho(D) immune globulin or intravenous immunoglobulin;
* Within 2 weeks - plasmap…
What they're measuring
1
Number of Participants With Adverse Events
Timeframe: From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.