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CompletedNCT05251090Updated Aug 22, 2023

A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for Injection

A Phase 1 interventional study of ADVATE and FRSW107 in Hemophilia A, sponsored by Jiangsu Gensciences lnc.. Completed at 6 sites in China. Open to male participants aged Up to 12 Years. Per ClinicalTrials.gov, last updated 2023-08-22.

Sponsored by Jiangsu Gensciences lnc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jun 2021, registered Feb 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
Up to 12 Years
Sex
Male
01

Study summary

Primary objective: To assess the pharmacokinetics of Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection (FRSW107) Secondary objectives: To assess Safety and Tolerability by monitoring FVIII recovery and adverse events in Severe Hemophilia A.

02

Conditions studied

  • Hemophilia A

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Keywords

  • Hemophilia A;Pharmacokinetics;Child;Safety and Tolerability
03

In context

Hemophilia A

866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.

This study's enrollment of 13 is below the median of 28 across 512 interventional studies indexed under Hemophilia A.

Browse Hemophilia A studies →

Lead sponsor

Jiangsu Gensciences lnc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
Up to 12 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • The activity of the coagulation factor VIII (FVIII:C) \< 1%. Less than 6 years old Patients previously treated with FVIII concentrate (s) for a minimum of 50 exposure days (EDs) prior to study entry. 6 years old to 12 years old Patients previously treated with FVIII concentrate (s) for a minimum of 150 exposure days (EDs) prior to study entry.
  • Normal prothrombin time or INR \< 1.3.
  • Negative lupus anticoagulant.

Key Exclusion Criteria:

  • Hypersensitive to any of the excipients of the test materials (e.g. allergic to murine or hamster origin heterologous proteins).
  • History of hypersensitivity or anaphylaxis associated with any FVIII or II immunoglobulin administration.
  • Current FVIII inhibitor-positive or history of FVIII inhibitor-positive.
  • Other coagulation disorder(s) in addition to hemophilia A.
  • Infusion of any products containing FVIII within 72 h prior to administration.
  • Significant hepatic or renal impairment (ALT and AST > 2×ULN; serum bilirubin level > 2 × upper limit of normal (ULN), BUN > 2×ULN, Cr > 2.0 ULN).
  • One or more clinically significant tests for Human Immunodeficiency Virus (HIV), Antisyphilitic spirulina (TPHA) and Hepatitis C Virus (HCV) Antibody.
  • Patients who received any anticoagulant or antiplatelet therapy within one week prior screening or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials.
  • Patients having major surgery or receiving blood or bood components transfusion within 4 weeks prior screening or having planned major surgery schedule during the study.
  • Patients who previously participated in the other clinical trials within one month prior to administration.
  • Any life-threatening disease or condition which, according to the investigator's judgment, could not benefit from the trial participation.
  • Patient who is considered by the other investigators not suitable for clinical study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Arm 1

    Subjects(up to 12 years of age) received two treatments: 50 IU/kg ADVATE in the first period, followed by 50 IU/kg FRSW107 in the second period.

    Drug: ADVATE · Drug: FRSW107

Interventions

  • DrugADVATE

    50 international units (IU)/kg, a single dose.

  • DrugFRSW107

    50 IU/kg, a single dose.

    Also known as: Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection

06

What researchers measure

Primary outcomes

  1. Maximum measured concentration of FVIII:C (Cmax)

    Measured by aPTT Clotting Assay.

    Time frame: Pre-dose and post dose up to 8 days.

  2. Time required for the concentration of the drug to reach half of its original value (T1/2)

    Measured by aPTT Clotting Assay.

    Time frame: Pre-dose and post dose up to 8 days

  3. Area Under the Curve to Infinity (AUC)

    Measured by aPTT Clotting Assay.

    Time frame: Pre-dose and post dose up to 8 days.

  4. The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time (CL).

    Measured by aPTT Clotting Assay.

    Time frame: Pre-dose and post dose up to 8 days.

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE V5.0.

    Adverse events related to Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection according to Common Terminology Criteria for Adverse Events (CTCAE) NCI.V5.0.

    Time frame: Post dose up to 32 days.

  2. Development of Inhibitor

    Measured by the Nijmegen-Modified Bethesda Assay.

    Time frame: Pre-dose and post dose up to 32 days.

07

Study locations

6 sites
  • Beijing Children's Hospital,Capital Medical University
    Beijing, Beijing 100045, China
  • Shenzhen Children's Hospita
    Shenzhen, Guangdong 518000, China
  • Nanfang Hospital of Southern Medical University
    Guangzhou, Guangzhou 510515, China
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
    Wuhan, Hubei 430000, China
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong 266000, China
  • Chengdu Women's and Children's Central Hospital
    Chengdu, Sichuan 610000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05251090
Lead sponsor
Jiangsu Gensciences lnc.
Responsible party
Sponsor
First posted
Feb 22, 2022
Start date
Jun 16, 2021
Primary completion
Nov 15, 2021
Completion
May 9, 2022
Last update
Aug 22, 2023

Study contacts

Runhui Wu, PhD
principal investigator · Beijing Children's Hospital
Xiaoling Wang, MA.Sc
principal investigator · Beijing Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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