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A Randomized, Placebo-controlled Study of the Treatment of Iron Deficiency Anemia (IDA) by Ferric Pyrophosphate Citrate (FPC) Delivered Via Infusion Pump in Patients Receiving Home Infusion Therapy

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Trial Profile

A Randomized, Placebo-controlled Study of the Treatment of Iron Deficiency Anemia (IDA) by Ferric Pyrophosphate Citrate (FPC) Delivered Via Infusion Pump in Patients Receiving Home Infusion Therapy

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 06 Oct 2023

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At a glance

  • Drugs Ferric pyrophosphate (Primary)
  • Indications Iron deficiency anaemia
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Rockwell Medical Technologies

    • Most Recent Events

    • 14 Dec 2021 According to a Rockwell Medical India media release, the company received a feedback from the FDA requesting additional data related to the microbiology and short-term stability of FPC be submitted to further support the drug administration method proposed for the study. The company expects to run these additional studies, complete the required analysis, and provide the requested data in the first half of 2022.
    • 16 Aug 2021 According to a Rockwell Medical India media release, company received a written response to pre-IND submission and intend to engage with the FDA to clarify and refine study design. In the meantime, company continue to work on the logistics and preparatory aspects of the trial. Assuming positive FDA feedback, comapny expect a potential commencement date in 2H 2021.
    • 28 Jun 2021 According to a Rockwell Medical India media release, the company has submitted a pre-IND (Investigational New Drug) meeting request with the U.S. Food and Drug Administration (FDA) in support of this trial.

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