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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Peking Union Medical College Hospital
Beijing, , 100032 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia B
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT02213250
Pfizer
Completed
An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B

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An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B
An Open-label, Single Dose Pharmacokinetic Study Of Benefix (Nonacog Alfa, Recombinant Factor Ix) In Male Chinese Subjects With Hemophilia B
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hemophilia B
Drug: BENEFIX
Single dose of 50 IU/kg of BeneFIX by intravenous infusion within 10 minutes.
Experimental: BeneFIX
Intervention: Drug: BENEFIX
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2015
April 2015   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: Male
6 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT02213250
B1821048
2015-003027-61 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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