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Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Severe Hemophilia A

Intervention: rFVIIIFc (Biological)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

Overall contact:
Biogen, Email: clinicaltrials@biogen.com

Summary

The primary objective of the study is to compare the pharmacokinetic (PK) of recombinant coagulation factor VIII Fc fusion protein (rFVIIIFc) manufactured at the current scale of 2000 L (2K) to the PK of rFVIIIFc manufactured at the 15,000 L (15K) scale in previously treated subjects with severe hemophilia A. The secondary objectives are: to characterize the PK of rFVIIIFc manufactured at the 15K scale at the 15K baseline and after 13 weeks of treatment; to characterize the PK of rFVIIIFc manufactured at the 15K scale at 1000 IU/vial and a higher strength vial; and to evaluate the safety of rFVIIIFc manufactured at the 15K scale.

Clinical Details

Official title: A Randomized, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) Manufactured at 15K Scale and at Different Vial Strengths in Previously Treated Subjects With Severe Hemophilia A

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

Area under the concentration time curve from time zero to infinity (AUCinf) for PK1 and PK2

Incremental recovery (IR) for PK1 and PK2

Secondary outcome:

area under the concentration-time curve from time zero to infinity (AUCinf) for PK2 and PK3

incremental recovery (IR) for PK2 and PK3

the maximum rFVIIIFc activity (Cmax) for PK2 and PK3

half-life (t½) for PK2 and PK3

clearance (CL) for PK2 and PK3

volume of distribution at steady state (Vss) at PK2 and PK3

mean residence time (MRT) at PK2 and PK3

AUCinf of rFVIIIFc manufactured at the 15K scale at different vial strengths

IR of rFVIIIFc manufactured at the 15K scale at different vial strengths

Cmax of rFVIIIFc manufactured at the 15K scale at different vial strengths

t½ of rFVIIIFc manufactured at the 15K scale at different vial strengths

CL of rFVIIIFc manufactured at the 15K scale at different vial strengths

Vss of rFVIIIFc manufactured at the 15K scale at different vial strengths

MRT of rFVIIIFc manufactured at the 15K scale at different vial strengths

Cmax at PK1 and Pk2

t½ at PK1 and Pk2

CL at PK1 and Pk2

Vss at PK1 and Pk2

MRT at PK1 and Pk2

Development of inhibitors as measured by the Nijmegen-modified Bethesda assay

Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)

Detailed description: PK assessments are in 3 phases: PK1: PK assessments following single injection of rFVIIIFc manufactured at the 2K scale. PK2: PK assessments are made following a single injection of rFVIIIFc manufactured at the 15K scale where participants are randomized to the 1000 IU vial or a higher strength vial. PK3: PK assessments are made following 13 weeks of rFVIIIFc treatment manufactured at the 15K scale where participants are randomized to the 1000 IU vial or a higher strength vial. After study completion, in countries where rFVIIIFc is not commercially available, eligible subjects will be offered enrollment into a long-term safety and efficacy extension study (8HA01EXT [NCT01454739]).

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Key Inclusion Criteria:

- Have severe hemophilia A, defined as <1 IU/dL (<1%) endogenous FVIII as determined by

one-stage clotting assay from the central laboratory at Screening.

- Previously treated subject, defined as having at least 150 documented prior exposure

days (EDs) to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products at Day 1. Fresh frozen plasma treatment must not be considered in the count for documented exposure days.

- No history of a positive inhibitor test or clinical signs of decreased response to

FVIII administrations. Family history of inhibitors will not exclude the subject.

- No measurable inhibitor activity using the Nijmegen-modified Bethesda assay (≥0. 6

BU/mL is considered positive) at Screening. Key Exclusion Criteria:

- Current enrollment in any interventional clinical study in which an investigational

drug or approved therapy for investigational use is administered within 30 days prior to the Baseline Visit.

- Previous participation in this study.

- Any concurrent clinically significant major disease that, in the opinion of the

Investigator or Biogen, makes the subject unsuitable for participation in the study.

- Other coagulation disorder(s) in addition to hemophilia A.

- History of hypersensitivity or anaphylaxis associated with FVIII or IV immunoglobulin

administration. NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Locations and Contacts

Biogen, Email: clinicaltrials@biogen.com

Additional Information

Starting date: September 2015
Last updated: July 16, 2015

Page last updated: August 23, 2015

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