An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B

Hemophilia B Clinical Trial

Official title:

An Open-label, Single Dose Pharmacokinetic Study Of Benefix (Nonacog Alfa, Recombinant Factor Ix) In Male Chinese Subjects With Hemophilia B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213250
• Other study ID #: B1821048
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2014
• Last updated: May 18, 2015
• Start date: March 2015
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK study and to support the registration in China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Male Chinese subjects 6 years or older (weight =20kg) with moderate to severe hemophilia B (Factor IX activity =2%).

• Subjects should not have received an infusion of any Factor IX products for at least 4 days before the administration of BeneFIX on Day 1.

• Subjects must be in a non-bleeding state before the administration of BeneFIX on Day 1.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.

• Diagnosed with any other bleeding disorder in addition to hemophilia B.

• Current FIX inhibitor or history of FIX inhibitor (defined as > Upper Limit of Normal (ULN) of the reporting lab).

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia B

Intervention

Drug:
• BENEFIX
Single dose of 50 IU/kg of BeneFIX by intravenous infusion within 10 minutes.

Locations

Country	Name	City	State
China	Hematology Department,Beijing Children's Hospital, Capital Medical University	Beijing
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)		0 to 96hours post dose	No
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)		0 to 96hours post dose	No
Primary	Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)		0 to 96hours post dose	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0 to 96hours post dose	No
Primary	Systemic Clearance (CL)		0 to 96hours post dose	No
Primary	Volume of Distribution at Steady State (Vss)		0 to 96hours post dose	No
Primary	Terminal phase rate constant (Kel)		0 to 96hours post dose	No
Primary	Plasma Decay Half-Life (t1/2)		0 to 96hours post dose	No
Primary	mean resident time(MRT)	mean resident time	0 to 96hours post dose	No
Primary	incremental recovery		0 to 96hours post dose	No

External Links

•   To obtain contact information for a study center near you, click here.