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Study of PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Male Chinese Subjects With Hemophilia A

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Phase I Unit, Clinical Pharmacology Research Center, Peking Union Medical College Hospital
Beijing, , 100032 China
Contact
1-800-718-1021
ClinicalTri[email protected]
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
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

Subjects must meet all of the following inclusion criteria to be eligible for enrollment in
the study:

1. Male Chinese subjects 6 years or older (weight >20 kg) with severe hemophilia A
(factor VIII activity 150 exposure days to any
FVIII-containing products.

2. Subjects should not have received an infusion of any FVIII products for at least 3
days (at least 72 hours) before the administration of Xyntha on Day 1.

3. Subjects must be in a non bleeding state before the administration of Xyntha on Day 1.

4. Evidence of a personally or legally acceptable representative (legally acceptable
representative is only applicable to pediatric subjects) signed and dated informed
consent document indicating that the subject has been informed of all pertinent
aspects of the study.

5. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.

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

Subjects with any of the following characteristics/conditions will not be included in the
study:

1. Current FVIII inhibitor or history of FVIII inhibitor (defined as > upper limit of
normal (ULN) of the local reporting laboratory).

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

3. Diagnosed with any other bleeding disorder in addition to hemophilia A.

4. Documented Human Immunodeficiency Virus (HIV).

5. Subjects anticipating elective surgery or other invasive procedure within 1 month
following study entry.

6. Treatment with immunomodulatory therapy within 30 days or 5 half lives whichever is
longer, prior to study entry or planned use for the duration of study participation.

7. Subjects with known hypersensitivity to the active substance or to any of the
excipients of Xyntha.

8. Subjects with a known hypersensitivity to Chinese Hamster Ovary cell (CHO cell)
proteins.

9. Subjects with ANY of the following abnormalities in clinical laboratory tests at
screening, as assessed by the study specific laboratory and confirmed by a single
repeat, if deemed necessary: significant hepatic or renal impairment (alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN, or total
bilirubin >2 x ULN or serum creatinine >2 x ULN), prothrombin time >1.5 x ULN,
platelet count

10. Unwilling or unable to follow the terms of the protocol.

11. Any condition which may compromise the subject's ability to comply with and/or perform
study related activities or that poses a clinical contraindication to study
participation, in the opinion of the investigator or sponsor.

12. A positive urine drug screen.

13. History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces
(150 mL) of wine, 12 ounces (360 mL) of beer, or 1.5 ounces (45 mL) of hard liquor)
within 6 months of screening.

14. Treatment with an investigational drug within 30 days or 5 half lives preceding Day 1,
whichever is longer.

15. Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic),
following at least 5 minutes of supine rest. If blood pressure (BP) is 140 mm Hg
(systolic) or 90 mm Hg (diastolic), the BP should be repeated two more times and the
average of the three BP values should be used to determine the subject's eligibility.

16. Screening supine 12 lead ECG demonstrating QTcF >450 or a QRS interval >120 msec msec.
If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more
times and the average of the three QTcF values should be used to determine the
subject's eligibility.

17. Blood donation (excluding plasma donations) of approximately 500 mL or more within 56
days prior to dosing.

18. History of sensitivity to heparin or heparin induced thrombocytopenia.

19. Unwilling or unable to comply with the Lifestyle Guidelines described in this
protocol.

20. Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are Pfizer employees directly involved in the conduct of
the study.

21. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.

22. Subjects with history of infection within 1 week prior to study entry.

23. Male subjects with partners currently pregnant and male subjects able to father
children who are unwilling or unable to use a highly effective method of contraception
as outlined in this protocol for the duration of the study and for at least 28 days
after the last dose of investigational product.

NCT02461992
Pfizer
Completed
Study of PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Male Chinese Subjects With Hemophilia A

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Study of PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Male Chinese Subjects With Hemophilia A
An Open-label, Single Dose Pharmacokinetic Study Of Xyntha (Moroctocog Alfa (Af-cc), Recombinant Factor Viii) In Male Chinese Subjects With Hemophilia A
An open-label, single dose pharmacokinetic study of Xyntha (Moroctocog Alfa (AF-CC), Recombinant Factor VIII) in male Chinese subjects with hemophilia A
The purpose of this study is to obtain pharmacokinetic profiles of FVIII:C after Xyntha administration in Chinese patients with severe hemophilia A, which is in support of the continued registration of Xyntha in China
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Basic Science
Hemophilia A
Drug: Intravenous infusions of Xyntha
A single dose 50IU/kg dose of Xyntha administered by intravenous infusion within 10 minutes on Day 1
Experimental: Intravenous infusion of Xyntha
observation arm
Intervention: Drug: Intravenous infusions of Xyntha
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
August 2015
August 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:

  1. Male Chinese subjects 6 years or older (weight >20 kg) with severe hemophilia A (factor VIII activity <1%) previously treated with > 150 exposure days to any FVIII-containing products.
  2. Subjects should not have received an infusion of any FVIII products for at least 3 days (at least 72 hours) before the administration of Xyntha on Day 1.
  3. Subjects must be in a non bleeding state before the administration of Xyntha on Day 1.
  4. Evidence of a personally or legally acceptable representative (legally acceptable representative is only applicable to pediatric subjects) signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  5. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Subjects with any of the following characteristics/conditions will not be included in the study:

  1. Current FVIII inhibitor or history of FVIII inhibitor (defined as > upper limit of normal (ULN) of the local reporting laboratory).
  2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at Screening.
  3. Diagnosed with any other bleeding disorder in addition to hemophilia A.
  4. Documented Human Immunodeficiency Virus (HIV).
  5. Subjects anticipating elective surgery or other invasive procedure within 1 month following study entry.
  6. Treatment with immunomodulatory therapy within 30 days or 5 half lives whichever is longer, prior to study entry or planned use for the duration of study participation.
  7. Subjects with known hypersensitivity to the active substance or to any of the excipients of Xyntha.
  8. Subjects with a known hypersensitivity to Chinese Hamster Ovary cell (CHO cell) proteins.
  9. Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat, if deemed necessary: significant hepatic or renal impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN, or total bilirubin >2 x ULN or serum creatinine >2 x ULN), prothrombin time >1.5 x ULN, platelet count <80,000 L. Subjects with Gilbert's disease may be enrolled.
  10. Unwilling or unable to follow the terms of the protocol.
  11. Any condition which may compromise the subject's ability to comply with and/or perform study related activities or that poses a clinical contraindication to study participation, in the opinion of the investigator or sponsor.
  12. A positive urine drug screen.
  13. History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces (150 mL) of wine, 12 ounces (360 mL) of beer, or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
  14. Treatment with an investigational drug within 30 days or 5 half lives preceding Day 1, whichever is longer.
  15. Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is 140 mm Hg (systolic) or 90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility.
  16. Screening supine 12 lead ECG demonstrating QTcF >450 or a QRS interval >120 msec msec. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility.
  17. Blood donation (excluding plasma donations) of approximately 500 mL or more within 56 days prior to dosing.
  18. History of sensitivity to heparin or heparin induced thrombocytopenia.
  19. Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
  20. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
  21. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  22. Subjects with history of infection within 1 week prior to study entry.
  23. Male subjects with partners currently pregnant and male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
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
 
 
NCT02461992
B1831082
2015-003685-88 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2016

ICMJE     Data element required by the

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

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