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A Phase 2, Multi-center, Non-controlled, Open-label Dose Escalation Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Orally Administered OPC-67683 Two Times Daily to Patients With Pulmonary Multidrug-Resistant Tuberculosis Refractory to Conventional Treatment

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A Phase 2, Multi-center, Non-controlled, Open-label Dose Escalation Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Orally Administered OPC-67683 Two Times Daily to Patients With Pulmonary Multidrug-Resistant Tuberculosis Refractory to Conventional Treatment

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 15 Nov 2021

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At a glance

  • Drugs Delamanid (Primary)
  • Indications Pulmonary tuberculosis
  • Focus Adverse reactions; Pharmacokinetics

    • 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
    • 15 Mar 2012 Actual end date (12 May 2011) added as reported by European Clinical Trials Database.
    • 15 Mar 2012 Status changed from active, no longer recruiting to completed as reported by European Clinical Trials Database.

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