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A Phase 2, Multi-center, Uncontrolled, Open-label Trial to Evaluate Safety, tolerability, and Efficacy of Orally Administered OPC-67683 as 100 mg BID with optional titration to 200 mg BID for up to Six Months Exposure in Patients with Pulmonary Multi-drug Resistant Tuberculosis [EXTENSION OF 700034594]

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A Phase 2, Multi-center, Uncontrolled, Open-label Trial to Evaluate Safety, tolerability, and Efficacy of Orally Administered OPC-67683 as 100 mg BID with optional titration to 200 mg BID for up to Six Months Exposure in Patients with Pulmonary Multi-drug Resistant Tuberculosis [EXTENSION OF 700034594]

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 02 Nov 2021

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At a glance

  • Drugs Delamanid (Primary)
  • Indications Pulmonary tuberculosis
  • Focus Adverse reactions; Registrational
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

    • Most Recent Events

    • 26 Oct 2020 Results (N=744) of a population pharmacokinetic analysis of data pooled from three phase II trials (Trials 204, 208 and 210) and one phase III trial (213) published in the Antimicrobial Agents and Chemotherapy
    • 03 Apr 2013 New trial record
    • 27 Mar 2013 Otsuka Pharmaceutical filed an application with the Pharmaceutical and Medical Devices Agency in Japan (PMDA) to market delamanid based on the results of this study, according to a company media release.

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