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05/12/22

Romiplostim in children with immune thrombocytopenia: a phase 3, randomised, double-blind, placebo-controlled study.

Background: The thrombopoietin receptor agonist romiplostim could be an effective treatment in symptomatic children with persistent or chronic immune thrombocytopenia....

  • 1 min read
  • Source: The Lancet
Clinical trial
29/09/11

Safety and Efficacy Study of Romiplostim to Treat ITP in Pediatric Subjects

The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of thrombocytopenia in pediatric subjects...

  • 1 min read
  • Source: Clinicaltrials.gov
Drug news
21/04/16

Nplate (romiplostim) Phase III study in children with symptomatic immune thrombocytopenia.-Amgen

Amgen has announced that The Lancet published results from a Phase III randomized, double-blind, placebo-controlled study of Nplate (romiplostim) in...

  • 1 min read
Drug information
17/12/21

Nplate vial

Adults: Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Paediatrics: Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).

  • 1 min read
Clinical trial
09/09/14

A Phase 3 Randomized, Double Blind, Placebo Controlled Study to Determine the Safety and Efficacy of Romiplostim in Thrombocytopenic Pediatric Subjects with Immune Thrombocytopenia (ITP)

The primary objective is to evaluate the efficacy of romiplostim in the treatment of thrombocytopenia in pediatric subjects with immune...

  • 1 min read
  • Source: ClinicalTrialsRegister.eu
Drug information
23/12/21

Nplate with Reconstitution Pack

Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).

  • 1 min read
Clinical trial
19/05/09

A prospective, phase IV, open-label, multi-center study evaluating changes in bone marrow morphology in adult subjects receiving romiplostim for the treatment of thrombocytopenia associated with immune (idiopathic) thrombocytopenia purpura (ITP)

The primary objective of this study is to evaluate the incidence of collagen fibrosis as evidenced by trichrome staining at...

  • 1 min read
  • Source: ClinicalTrialsRegister.eu
Clinical trial
20/10/09

An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects with immune (Idiopathic) Thrombocytopenia Purpura (ITP).

The primary objective of this study is to evaluate the safety of romiplostim as a long-term treatment in pediatric thrombocytopenic...

  • 1 min read
  • Source: ClinicalTrialsRegister.eu
Clinical trial
26/08/10

A phase 2, interventional, single arm study describing platelet responses and itp remission rates in adult subjects with immune thrombocytopenia purpura receiving romiplostim

The primary objective is to describe the number of months with a subject platelet response over a 12 month treatment...

  • 1 min read
  • Source: ClinicalTrialsRegister.eu
Drug news
16/12/18

FDA approves sBLA for NPlate to treat pediatric patients one year of age and older with immune thrombocytopenia. Amgen.

Amgen announced that the FDA has approved the supplemental Biologics License Application (sBLA) for Nplate (romiplostim) for the treatment of...

  • 1 min read
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