Recent Updates
Recently added Catalysts

Damoctocog

Phase 1

Hemophilia A | Small molecule | Hematology |Bayer AG|Last Updated: Sep 9, 2019

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Damoctocog · 1 trial · 1 indication

Phase 1 1
NCT03364998BAY94-9027 PK Study Comparing to Another Long Acting ProductHemophilia A
COMPLETED18 Analytics
PHASE1COMPLETED
BAY94-9027 PK Study Comparing to Another Long Acting Product
Hemophilia AUnlock trial analytics

Study Endpoints

Primary Endpoints

AUC from time 0 to the last data point
Pre-Dose and up to 120 hours post dose

Area under the concentration time profile curve.

Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
BAY94-9027 and EloctaEXPERIMENTALSubjects received two treatments: 60 IU/kg BAY94-9027 in the first period, followed by 60 IU/kg Elocta in the second period, with a washout period before each treatment
Elocta and BAY94-9027EXPERIMENTALSubjects received two treatments: 60 IU/kg Elocta in the first period, followed by 60 IU/kg BAY94-9027 in the second period, with a washout period before each treatment

Interventions

NameTypeDescription
Damoctocog (Jivi, BAY94-9027)DRUG60 international units (IU)/kg, given as a 10 minute injection, 1 dose
EloctaDRUG60 IU/kg, given as a 10 minute injection, 1 dose
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Males, age 18 to 65 years. * Subjects with Severe Hemophilia A with a documented plasma FVIII level of \< 1% * ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records Exclusion Criteria: * Evidence of current or past inhibitor antibody: * History of any...

Countries:Bulgaria
Unlock Eligibility Criteria

Frequently asked questions about Damoctocog

What is Damoctocog used for?

Damoctocog is an investigational small molecule being developed for the treatment of Hemophilia A. It is currently in Phase 1 clinical development. The drug is being studied in a clinical trial that has been completed, which enrolled 18 male participants aged 18 years and older in Bulgaria.

Who makes Damoctocog?

Damoctocog is being developed by Bayer AG, a pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The drug is currently in Phase 1 clinical development for the treatment of Hemophilia A.

What phase is Damoctocog in?

Damoctocog is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial for Damoctocog has been completed, with a total enrollment of 18 participants.

What clinical trials is Damoctocog in?

Damoctocog has one completed clinical trial registered under NCT03364998, titled 'BAY94-9027 PK Study Comparing to Another Long Acting Product'. This Phase 1 study enrolled 18 male participants with Hemophilia A in Bulgaria. The trial was controlled and randomized, but not double-blinded.

Is Damoctocog the same as BAY94-9027?

Yes, Damoctocog is also known as BAY94-9027. The clinical trial NCT03364998, which studied Damoctocog, is titled 'BAY94-9027 PK Study Comparing to Another Long Acting Product'. This trial was a Phase 1 study in Hemophilia A.