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Advate

Phase 1

Congenital Bleeding Disorder | Small molecule | Rare Disease |Novo Nordisk A/S|Last Updated: Feb 10, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

Advate · 1 trial · 2 indications

Phase 1 1
NCT00837356Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A SubjectsCongenital Bleeding Disorder
COMPLETED23 Analytics
PHASE1COMPLETED
Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects
Congenital Bleeding DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Recovery of FVIII 30 min after administration, half-life, AUC, and clearance
at 30 days

Secondary Endpoints

Inhibitor development
at 30 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Advate®/turoctocog alfaEXPERIMENTAL -

Interventions

NameTypeDescription
Advate®DRUGSubjects will receive Advate® at a dose of 50 IU/kg body weight in the first session
turoctocog alfaDRUGAfter a washout period of 4 days, subjects will subsequently receive turoctocog alfa (recombinant factor VIII (N8)) at a dose of 50 IU/kg body weight in the second session
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Eligibility Criteria

Age Range12 Years to 55 Years
SexMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Severe haemophilia A (FVIII level less than or equal to 1%) * Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products * HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the en...

Countries:GermanyIsraelItalySpainSwitzerland
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Frequently asked questions about Advate

What is Advate used for?

Advate is used for congenital bleeding disorder, specifically Haemophilia A. It is being studied in a clinical trial for this condition. The drug is currently in Phase 1 development and is being investigated for its safety and action in the body.

Who makes Advate?

Advate is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the stock exchange under the ticker symbol NVO. The company is conducting clinical research on this drug for the treatment of congenital bleeding disorder.

What phase is Advate in?

Advate is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its safety and pharmacological action in patients with Haemophilia A.

What clinical trials is Advate in?

Advate is being studied in clinical trial NCT00837356, titled "Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects." This Phase 1 trial has been completed and enrolled 23 male participants aged 12 years and older.

Is Advate the same as N8?

Advate is not the same as N8. The clinical trial NCT00837356 compares the action and safety of N8 and Advate in Haemophilia A subjects. These are two distinct drugs being evaluated against each other in the study.