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A phase II, open-label, sequential-cohort, dose-escalation study of romiplostim in Japanese patients with chronic immune thrombocytopenic purpura.

Abstract
This phase II, multicenter, open-label, sequential-cohort, dose-escalation study was designed to evaluate the safety and efficacy of romiplostim, a novel peptibody that increases platelet production, in Japanese patients with chronic immune thrombocytopenic purpura (ITP). Sequential cohorts of four patients each received romiplostim (1, 3, or 6 microg/kg) subcutaneously on days 1 and 8 of the dose-escalation phase. Patients who achieved platelet responses (doubling of baseline platelet counts to > or =50 x 10(9)/L) continued romiplostim weekly during the treatment-continuation phase. Romiplostim produced dose-dependent increases in mean and peak platelet counts. Five patients received romiplostim during the treatment-continuation phase, with platelet counts > or =50 x 10(9)/L maintained in approximately half of the weekly assessments. Romiplostim was well tolerated. No severe, serious, or life-threatening adverse events were reported. No binding antibodies to romiplostim or thrombopoietin were detected. Romiplostim is safe and well tolerated in Japanese patients with chronic ITP and is effective in producing platelet count increases, consistent with the results from studies in non-Japanese patients. On the basis of these findings, a starting dose of 3 microg/kg was recommended for phase III evaluation of romiplostim in Japanese patients with chronic ITP.
AuthorsYukari Shirasugi, Kiyoshi Ando, Satoshi Hashino, Toshiro Nagasawa, Yoshiyuki Kurata, Yuji Kishimoto, Koji Iwato, Tomoko Ohtsu, Dietmar P Berger
JournalInternational journal of hematology (Int J Hematol) Vol. 90 Issue 2 Pg. 157-65 (Sep 2009) ISSN: 1865-3774 [Electronic] United States
PMID19543952 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Carrier Proteins
  • Receptors, Fc
  • Recombinant Fusion Proteins
  • romiplostim
  • Thrombopoietin
Topics
  • Adult
  • Aged
  • Asian Continental Ancestry Group
  • Carrier Proteins (administration & dosage, adverse effects)
  • Chronic Disease
  • Cohort Studies
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Male
  • Middle Aged
  • Platelet Count
  • Purpura, Thrombocytopenic, Idiopathic (drug therapy, ethnology)
  • Receptors, Fc (administration & dosage)
  • Recombinant Fusion Proteins (administration & dosage, adverse effects)
  • Thrombopoiesis (drug effects)
  • Thrombopoietin
  • Treatment Outcome
  • Young Adult

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