Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Randomized, Double-Blind, Placebo-controlled Phase 1/2 Study to Determine the Safety and Efficacy of AMG 531 in Thrombocytopenic Pediatric Subjects With Chronic Immune (Idiopathic) Thrombocytopenic Purpura

Trial Profile

A Randomized, Double-Blind, Placebo-controlled Phase 1/2 Study to Determine the Safety and Efficacy of AMG 531 in Thrombocytopenic Pediatric Subjects With Chronic Immune (Idiopathic) Thrombocytopenic Purpura

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 16 Jun 2019

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Romiplostim (Primary)
  • Indications Idiopathic thrombocytopenic purpura; Thrombocytopenia
  • Focus Adverse reactions
  • Sponsors Amgen
  • Most Recent Events

    • 14 Dec 2018 According to an Amgen media release, the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Nplate (romiplostim) for the treatment of pediatric patients one year of age and older with immune thrombocytopenia (ITP) for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy, based on the results of two placebo-controlled studies- Phase 3 and Phase 1/2.
    • 10 Nov 2017 According to an amgen media release, The CHMP of the European Medicines Agency (EMA) has adopted a positive opinion to expand the current indication for Nplate (romiplostim) to include the treatment of idiopathic thrombocytopenic purpura for patients one year of age and older.CHMP opinion was based on five studies including 4 completed studies (a Phase 3, a Phase 1/2 placebo-controlled study, two long-term safetyand efficacy studies) and one ongoing long-term safety and efficacy study.
    • 04 Jul 2014 New trial record
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top