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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05265286
Recruitment Status : Recruiting
First Posted : March 3, 2022
Last Update Posted : June 29, 2022
Sponsor:
Information provided by (Responsible Party):
Jiangsu Gensciences lnc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Severe Hemophilia A Drug: FRSW117 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicentre, Open-label Study to Evaluate the Pharmacokinetic, Safety and Preliminary Efficacy of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Subjects With Severe Hemophilia A
Actual Study Start Date : April 14, 2022
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : November 30, 2022


Arm Intervention/treatment
Experimental: 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.

Drug: 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.

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




Primary Outcome Measures :
  1. Maximum measured concentration of FVIII:C (Cmax) [ Time Frame: Pre-dose and post dose up to 10 days ]
    Measured by One-Stage Clotting Assay

  2. Time required for the concentration of the drug to reach half of its original value (T1/2) [ Time Frame: Pre-dose and post dose up to 10 days ]
    Measured by One-Stage Clotting Assay

  3. Area Under the Curve to Infinity (AUC) [ Time Frame: Pre-dose and post dose up to 10 days ]
    Measured by One-Stage Clotting Assay

  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) [ Time Frame: Pre-dose and post dose up to 10 days ]
    Measured by One-Stage Clotting Assay

  5. Evaluation of the level of anti-PEG-rFⅧFc antibody production in participants [ Time Frame: Pre-dose and post dose up to 36 days ]
  6. Evaluation of the level of anti-PEG antibody production in participants [ Time Frame: Pre-dose and post dose up to 36 days ]

Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE V5.0 [ Time Frame: Pre-dose and post dose up to 36 days ]
    Adverse events related to PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein according to Common Terminology Criteria for Adverse Events (CTCAE) NCI.V5.0.

  2. Development of Inhibitor [ Time Frame: Pre-dose and post dose up to 36 days ]
    Measured by the Nijmegen-Modified Bethesda Assay

  3. score of bleeding symptoms and Vital signs [ Time Frame: Pre-dose and post dose up to 36 days ]
    Response to treatment with PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for bleeding episodes, using the 4-point bleeding response scale



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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Hemophilia A is an X-chromosome-linked recessive inherited bleeding disorder caused by a deficiency of coagulation factor VIII (FVIII)
Accepts Healthy Volunteers:   No
Criteria

Key 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

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.• 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

Other protocol-defined inclusion/exclusion Criteria May Apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05265286


Contacts
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Contact: Weichuan Mo, PhD +86-010-67806990 weichuanmo@gensciences.cn
Contact: Yaping Zhang, MA.Sc +86-010-67806623 clinical@gensciences.cn

Locations
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China, Henan
People'S Hospital of Zhengzhou Recruiting
Zhengzhou, Henan, China, 450000
Contact: Shuxia Guo         
China, Jiangsu
Affiliated Hospital of Jiangnan University Recruiting
Wuxi, Jiangsu, China, 214100
Contact: Haiying Hua         
China, Shandong
The Affiliated Hospital of Qingdao University Recruiting
Qingdao, Shandong, China, 266000
Contact: Yu Cao         
Contact: Xianqi Feng         
People'S Hospital of Rizhao Recruiting
Rizhao, Shandong, China, 276800
Contact: Enqin Yang         
China, Tianjin
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College. Recruiting
Tianjin, Tianjin, China, 300020
Contact: Renchi Yang, PhD         
Sponsors and Collaborators
Jiangsu Gensciences lnc.
Investigators
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Principal Investigator: Renchi Yang, PhD Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College.
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Responsible Party: Jiangsu Gensciences lnc.
ClinicalTrials.gov Identifier: NCT05265286    
Other Study ID Numbers: CTR20220238
First Posted: March 3, 2022    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Gensciences lnc.:
Pharmacokinetics;
Safety;
immunogenicity;
Preliminary efficacy
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants