A Phase 2/3, Multicenter, Open-label Clinical Study to Assess the Safety and Efficacy of BAY86-6150 in Subjects With Hemophilia A or B With Inhibitors, Composed of 2 Parts (A & B). Part A: Sequential Cohorts of Four Dose Levels of the Modified rFVIIa BAY86-6150 Assessed in a Non-controlled Dose Response Design in Acutely Bleeding Subjects and for PK/ PD in an Intra-individual Crossover Design Compared With One Fixed Dose of Eptacog Alfa in Non-bleeding Subjects. Part B: Confirmatory Study to Further Investigate the Efficacy and Safety of BAY86-6150

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT01625390

Title field or adapter rule

protocolSection.identificationModule.officialTitle

Ingested At

2026-04-28T10:35:53.485014+00:00

Published At

2015-07-01T00:00:00+00:00

Record Updated At

2015-07-01

Timestamp Basis

source retrieval time was not retained by the feed adapter

Date limitation

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Fields recorded by this source

protocolSection.conditionsModule.conditions

["Hemophilia A, Hemophilia B"]

protocolSection.statusModule.lastUpdatePostDateStruct.date

"2015-07-01"

protocolSection.identificationModule.nctId

"NCT01625390"

protocolSection.identificationModule.officialTitle

"A Phase 2/3, Multicenter, Open-label Clinical Study to Assess the Safety and Efficacy of BAY86-6150 in Subjects With Hemophilia A or B With Inhibitors, Composed of 2 Parts (A \u0026 B). Part A: Sequential Cohorts of Four Dose Levels of the Modified rFVIIa BAY86-6150 Assessed in a Non-controlled Dose Response Design in Acutely Bleeding Subjects and for PK/ PD in an Intra-individual Crossover Design Compared With One Fixed Dose of Eptacog Alfa in Non-bleeding Subjects. Part B: Confirmatory Study to Further Investigate the Efficacy and Safety of BAY86-6150"

protocolSection.statusModule.overallStatus

"COMPLETED"

protocolSection.designModule.phases

["PHASE2", "PHASE3"]

protocolSection.statusModule.resultsFirstPostDateStruct.date

""

Study condition terms

• Hemophilia A, Hemophilia B (protocolSection.conditionsModule.conditions)

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

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