A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-14

Study Completion Date

2022-08-21

Brief Summary

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Primary objective: To assess the pharmacokinetics, Safety and immunogenicity of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A(FRSW117) Secondary objectives: To assess Preliminary efficacy of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A.

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Detailed Description

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Conditions

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Severe Hemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 prophylaxis treatment

Subjects of high dose group are being received four doses of FRSW117. dosing on day1(ED1), day8(ED2), day15(ED3), day22(ED4) respectively.

Subjects of low dose group are being received four doses of FRSW117. dosing on day1(ED1), day8(ED2), day15(ED3), day22(ED4) respectively.

All subjects are being received PK assessment in ED1 and ED4.

Group Type EXPERIMENTAL

FRSW117

Intervention Type DRUG

Subjects of high dose group are being received four doses(50 IU/kg,once a week or every 7 days) of FRSW117.

Subjects of low dose group (40 IU/kg,once a week or every 7 days)are being received four doses of FRSW117.

Interventions

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FRSW117

Subjects of high dose group are being received four doses(50 IU/kg,once a week or every 7 days) of FRSW117.

Subjects of low dose group (40 IU/kg,once a week or every 7 days)are being received four doses of FRSW117.

Intervention Type DRUG

Other Intervention Names

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PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

Eligibility Criteria

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Inclusion Criteria

* The activity of the coagulation factor VIII (FVIII:C) \< 1%.
* 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

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.• Significant hepatic or renal impairment (ALT and AST \> 2×ULN; serum bilirubin level \> 2 × upper limit of normal (ULN), Urea /BUN \> 2×ULN, Cr \> 176.8 µmol/L)
* 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 screening
* 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

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No