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An Open-label, Uncontrolled, Single-arm, Multicenter Phase IIIb Study to Assess the Efficacy and Safety of BE1116 in Japanese Subjects Receiving Vitamin K Antagonist Therapy With an Elevated INR and Either Acute Major Bleeding or a Requirement for Urgent Reversal of Vitamin K Antagonist Therapy for a Surgical or Invasive Medical Procedure

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Record identity and dates

Source
ClinicalTrials.gov
Source record ID
NCT02281201
Title field or adapter rule
protocolSection.identificationModule.officialTitle
Ingested At
2026-04-28T10:36:13.557798+00:00
Published At
2016-05-04T00:00:00+00:00
Record Updated At
2016-05-04
Timestamp Basis
source retrieval time was not retained by the feed adapter
Date limitation
source retrieval time was not retained by the feed adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions
["Acute Major Bleeding", "Reversal of Coagulopathy"]
protocolSection.statusModule.lastUpdatePostDateStruct.date
"2016-05-04"
protocolSection.identificationModule.nctId
"NCT02281201"
protocolSection.identificationModule.officialTitle
"An Open-label, Uncontrolled, Single-arm, Multicenter Phase IIIb Study to Assess the Efficacy and Safety of BE1116 in Japanese Subjects Receiving Vitamin K Antagonist Therapy With an Elevated INR and Either Acute Major Bleeding or a Requirement for Urgent Reversal of Vitamin K Antagonist Therapy for a Surgical or Invasive Medical Procedure"
protocolSection.statusModule.overallStatus
"COMPLETED"
protocolSection.designModule.phases
["PHASE3"]
protocolSection.statusModule.resultsFirstPostDateStruct.date
""

Study condition terms

  • Acute Major Bleeding (protocolSection.conditionsModule.conditions)
  • Reversal of Coagulopathy (protocolSection.conditionsModule.conditions)

Intervention details are not present in the imported fields for this record. No drug-condition relationship is inferred from co-listing.

This index keeps the source fields it imported; it may not contain the complete original record. Verify wording and context in the linked source.