Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is being conducted to compare how moroctocog alfa (AF-CC) acts in the body when administered as 2 different dose presentations. The first is the current product vials with prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Moroctocog Alfa (AF-CC) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Hemophilia A Patients

NCT04396639

Hemophilia A

COMPLETED PHASE4

Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients

NCT00914459

Hemophilia A

COMPLETED PHASE4

Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII

NCT00543439

Hemophilia A

COMPLETED PHASE3

Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A

NCT01027377

Severe Hemophilia A

COMPLETED PHASE1

A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A

NCT05911763

Hemophilia A

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is being conducted in order to satisfy a post-approval EMA commitment to compare the pharmacokinetics of the 2 dose presentations used in this study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemophilia A

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sequence 1

Subjects randomized to receive Treatment A during Period 1, then Treatment B during Period 2.

Group Type EXPERIMENTAL

moroctocog alfa (AF-CC)

Intervention Type DRUG

Treatment A: 3000 IU moroctocog alfa (AF-CC) dual chamber syringe (including diluent); Treatment B: 1000 IU + 2000 IU moroctocog alfa (AF-CC) vials and separate diluent syringes

Sequence 2

Subjects randomized to receive Treatment B during Period 1, then Treatment B during Period 2.

Group Type EXPERIMENTAL

moroctocog alfa (AF-CC)

Intervention Type DRUG

Treatment B: 1000 IU + 2000 IU moroctocog alfa (AF-CC) vials and separate diluent syringes; Treatment A: 3000 IU moroctocog alfa (AF-CC) dual chamber syringe (including diluent)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

moroctocog alfa (AF-CC)

Treatment A: 3000 IU moroctocog alfa (AF-CC) dual chamber syringe (including diluent); Treatment B: 1000 IU + 2000 IU moroctocog alfa (AF-CC) vials and separate diluent syringes

Intervention Type DRUG

moroctocog alfa (AF-CC)

Treatment B: 1000 IU + 2000 IU moroctocog alfa (AF-CC) vials and separate diluent syringes; Treatment A: 3000 IU moroctocog alfa (AF-CC) dual chamber syringe (including diluent)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male patients at least 18 years old with severe or moderately severe hemophilia A (facto VIII concentration less than or equal to 2%).
* Negative test for facto VIII inhibitor.
* If applicable, HIV or hepatitis treatment is stable at the time of enrollment.
* Ability to abstain from use of FVIII products for 72 hours at a time.

Exclusion Criteria

* History of any positive test result for factor VIII inhibitor.
* Presence of any bleeding disorder in addition to Hemophilia A.
* Body weight less than 50 kg.
* History of alcoholism.
* Treatment with investigational drug or device within 30 days prior to the Screening visit.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No