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CompletedNCT01790828Updated Aug 17, 2015Results posted

Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A

An observational study in Hemophilia A, sponsored by Pfizer. Completed at 4 sites in South Korea. Per ClinicalTrials.gov, last updated 2015-08-17.

Sponsored by Pfizer · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
42
Sex
All
01

Study summary

This study is to describe the safety and efficacy of Xyntha® during the usual care setting.

Read the detailed description

non probability sample

02

Conditions studied

  • Hemophilia A

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03

In context

Hemophilia A

885 studies on the registry are indexed under Hemophilia A; 139 are open to participants now.

This study's enrollment of 42 is below the median of 80 across 322 observational studies indexed under Hemophilia A.

Browse Hemophilia A studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hemophilia A

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients or legally authorized representatives of pediatric patients agree to provide written informed consent form (data privacy statement).
  • Pediatric and adult patients who have been treated with Xyntha for Hemophilia A from first approved date by KFDA, or who are planned to be newly prescribed Xyntha.

Exclusion criteria

Exclusion Criteria:

  • Patients with a known history of hypersensitivity to original or reformulated Xyntha or any component of the product.
  • Patients with a known history of hypersensitivity to hamster protein.
  • Patients participating in an interventional trial of any investigational drug or device.
05

Study design

Time perspective
Prospective
Enrollment
42 participants (actual)

Groups and cohorts

  • Xyntha group

    Xyntha will be administered according to physician's discretion.

    Drug: Xyntha : coagulation factor IIIV (recombinant)

Interventions

06

What researchers measure

Primary outcomes

  1. Percentage of Participants by Family History of Factor VIII Inhibitor

    Time frame: 4 years

Secondary outcomes

  1. Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants)

    Time frame: 4 years

  2. Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age

    Time frame: 4 years

  3. Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Greater Than or Equal to (≥) 18 Years of Age

    Time frame: 4 years

  4. Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy (All Participants)

    Response categories were excellent, good, moderate, or no response.

    Time frame: 4 years

  5. Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants <18 Years of Age

    Response categories were excellent, good, moderate, or no response.

    Time frame: 4 years

  6. Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants ≥18 Years of Age

    Response categories were excellent, good, moderate, and no response.

    Time frame: 4 years

  7. Number of Participants With Less-Than-Expected Therapeutic Effect (LETE) for On-Demand Therapy

    Less than expected therapeutic effect was defined as a 'no response' rating after each of two successive infusions less than or equl to (≤) 24 hours of on-demand therapy.

    Time frame: 4 years

  8. Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants)

    Time frame: 4 years

  9. Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age

    Time frame: 4 years

  10. Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age

    Time frame: 4 years

  11. Percentage of Participants Experiencing Hemorrhages During Prophylaxis

    Time frame: 4 years

  12. Annualized Bleeding Rates During Prophylaxis

    Annualized bleeding rate defined as total number of breakthrough bleeds within 48 hours (for prophylaxis purpose) divided by (/) \[(total period of date of bleeding)/365.25)\]

    Time frame: 4 years

  13. Number of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha

    Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleed wtihin 48 hours of prophylaxis infusion.

    Time frame: 4 years

  14. Average Infusion Dose During Prophylaxis (All Participants)

    Time frame: 4 years

  15. Average Infusion Dose During Prophylaxis in Participants <18 Years of Age

    Time frame: 4 years

  16. Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age

    Time frame: 4 years

  17. Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants)

    Time frame: 4 years

  18. Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age

    Time frame: 4 years

  19. Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age

    Time frame: 4 years

07

Results

Posted Aug 17, 2015

Participant flow

Participant flow — Overall Study
MilestoneXyntha
Started42
Completed8
Not completed34
Withdrew: Other34

Outcome measures

PrimaryPercentage of Participants by Family History of Factor VIII Inhibitor
Time frame:
4 years
Reported as:
Number · percentage of participants
Percentage of Participants by Family History of Factor VIII Inhibitor
percentage of participantsXyntha
Yes0
No100.0
SecondaryNumber of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants)
Time frame:
4 years
Reported as:
Mean · infusions
Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants)
infusionsXyntha
Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants)1.40 ± 0.55
SecondaryNumber of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age
Time frame:
4 years
Reported as:
Mean · infusions
Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age
infusionsXyntha
Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age1.00 ± 0
SecondaryNumber of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Greater Than or Equal to (≥) 18 Years of Age
Time frame:
4 years
Reported as:
Mean · infusions
Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Greater Than or Equal to (≥) 18 Years of Age
infusionsXyntha
Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Greater Than or Equal to (≥) 18 Years of Age1.50 ± 0.58
SecondaryNumber of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy (All Participants)

Response categories were excellent, good, moderate, or no response.

Time frame:
4 years
Reported as:
Number · Number of responses
Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy (All Participants)
Number of responsesXyntha
Excellent5
Good2
Moderate0
No response0
SecondaryNumber of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants <18 Years of Age

Response categories were excellent, good, moderate, or no response.

Time frame:
4 years
Reported as:
Number · number of responses
Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants <18 Years of Age
number of responsesXyntha
Excellent1
Good0
Moderate0
No response0
SecondaryNumber of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants ≥18 Years of Age

Response categories were excellent, good, moderate, and no response.

Time frame:
4 years
Reported as:
Number · number of responses
Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants ≥18 Years of Age
number of responsesXyntha
Excellent4
Good2
Moderate0
No response0
SecondaryNumber of Participants With Less-Than-Expected Therapeutic Effect (LETE) for On-Demand Therapy

Less than expected therapeutic effect was defined as a 'no response' rating after each of two successive infusions less than or equl to (≤) 24 hours of on-demand therapy.

Time frame:
4 years

No measurements were reported for this outcome.

SecondaryAverage Infusion Dose Per Bleeding for On-Demand Therapy (All Participants)
Time frame:
4 years
Reported as:
Mean · IU
Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants)
IUXyntha
Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants)1997.00 ± 892.77
SecondaryAverage Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age
Time frame:
4 years
Reported as:
Median · IU
Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age
IUXyntha
Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age725.00 ± 892.77
SecondaryAverage Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age
Time frame:
4 years
Reported as:
Mean · IU
Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age
IUXyntha
Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age2315.00 ± 623.00
SecondaryPercentage of Participants Experiencing Hemorrhages During Prophylaxis
Time frame:
4 years
Reported as:
Number · percentage of participants
Percentage of Participants Experiencing Hemorrhages During Prophylaxis
percentage of participantsXyntha
All participants (n=41)0
Participants <18 years (n=4)0
Participants ≥18 years (n=37)0
SecondaryAnnualized Bleeding Rates During Prophylaxis

Annualized bleeding rate defined as total number of breakthrough bleeds within 48 hours (for prophylaxis purpose) divided by (/) \[(total period of date of bleeding)/365.25)\]

Time frame:
4 years

No measurements were reported for this outcome.

SecondaryNumber of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha

Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleed wtihin 48 hours of prophylaxis infusion.

Time frame:
4 years

No measurements were reported for this outcome.

SecondaryAverage Infusion Dose During Prophylaxis (All Participants)
Time frame:
4 years
Reported as:
Mean · IU
Average Infusion Dose During Prophylaxis (All Participants)
IUXyntha
Average Infusion Dose During Prophylaxis (All Participants)1926.70 ± 532.90
SecondaryAverage Infusion Dose During Prophylaxis in Participants <18 Years of Age
Time frame:
4 years
Reported as:
Mean · IU
Average Infusion Dose During Prophylaxis in Participants <18 Years of Age
IUXyntha
Average Infusion Dose During Prophylaxis in Participants <18 Years of Age1243.75 ± 894.51
SecondaryAverage Infusion Dose During Prophylaxis in Participants ≥18 Years of Age
Time frame:
4 years
Reported as:
Mean · IU
Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age
IUXyntha
Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age2000.16 ± 437.59
SecondaryTotal Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants)
Time frame:
4 years
Reported as:
Mean · IU
Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants)
IUXyntha
Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants)66371.00 ± 60985.45
SecondaryTotal Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age
Time frame:
4 years
Reported as:
Median · IU
Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age
IUXyntha
Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age2900.00 ± 894.51
SecondaryTotal Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age
Time frame:
4 years
Reported as:
Mean · IU
Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age
IUXyntha
Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age70104.59 ± 60704.87

Adverse events

Collected over Adverse events were collected up to 6 months after the first administration of Xyntha.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Xyntha—0/42 (0%)10/42 (23.8%)
Most frequent other events
Showing 10 of 14
Most frequent other events
EventXyntha
GastritisGastrointestinal disorders3/42
HaemarthrosisMusculoskeletal and connective tissue disorders2/42
MyalgiaMusculoskeletal and connective tissue disorders2/42
HeadacheNervous system disorders1/42
DyspepsiaGastrointestinal disorders1/42
Irritable bowel syndromeGastrointestinal disorders1/42
ArthralgiaMusculoskeletal and connective tissue disorders1/42
Ligament disorderMusculoskeletal and connective tissue disorders1/42
Muscle haemorrhageMusculoskeletal and connective tissue disorders1/42
Intervertebral disc disorderMusculoskeletal and connective tissue disorders1/42

Baseline characteristics

All enrolled participants

Age, Continuous
Age, Continuous(years)Xyntha
Mean36.4 ± 14.50
Sex: Female, Male
Sex: Female, Male(Participants)Xyntha
Female2
Male40
08

Study locations

4 sites
  • Yonsei Rehabilitation Clinic
    Guro-gu, Seoul 152-834, South Korea
  • Kim Hugh Chul Internal Medicine Clinic
    Songpa-gu, Seoul 138-879, South Korea
  • Pusan National University Hospital
    Busan, 632-739, South Korea
  • Kyung Hee University Hospital at Gangdong
    Seoul, 134-727, South Korea
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01790828
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Feb 13, 2013
Start date
Feb 2014
Primary completion
Aug 2014
Completion
Aug 2014
Results posted
Aug 17, 2015
Last update
Aug 17, 2015

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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