Eltrombopag Phase III Study In Chinese Chronic ITP Patients
Status:
Completed
Trial end date:
2018-11-22
Target enrollment:
Participant gender:
Summary
This randomized, double-blind and open-label phase III study aimed to determine the efficacy,
tolerance and safety of eltrombopag in Chinese chronic primary immune thrombocytopenia (ITP)
adult subjects. This study was be conducted in Chinese adult chronic ITP subjects who had not
responded to or had relapsed after previous treatment of ITP, including first line therapy
and /or splenectomy.
The primary objective of this study was to determine the efficacy of oral eltrombopag as a
thrombopoietic agent treating previously treated chronic Chinese ITP patients compared to
placebo. The secondary objective was to assess the safety and tolerability of eltrombopag
when administered for 6 weeks to previously treated adult chronic ITP patients compared with
placebo. In addition, the long-term efficacy and safety of eltrombopag treatment was also
evaluated in the 24-week extension open-label phase after the double-blind phase as one of
other study objectives. If the subject benefited from the eltrombopag treatment based on the
investigator's discretion, the subject could continue on eltrombopag treatment until the
commercial launch of eltrombopag in China. Furthermore, to understand the pharmacokinetics
(PK) profile of eltrombopag and to explore the relationship between the PK and
pharmacodynamics (PD) (platelet response), a PK/PD analysis was embedded in this phase III
study and conducted in the same patient population who participated this phase III study.