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KN057 Multiple Dose Study in Moderately Severe to Severe Hemophilia

Primary Purpose

Hemophilia

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
KN057 doseⅠ
KN057 dose Ⅱ
KN057 dose Ⅲ
Sponsored by
Suzhou Alphamab Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemophilia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male, 18-70 years old (including threshold), weight≥40kg;
  2. Moderately severe to severe hemophilia A or B (Factor VIII or Factor IX activity ≤2%)
  3. Participants who are enrolled into the Non-Inhibitor Cohort must meet the following criteria:

    ①negtive results of of inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in screening period.

    ②with ≥6 acute bleeding episodes (spontaneous or traumatic, not including episodes of bleeding during surgery) that required treatment within 6 months before screening and willing to continue to receive on-demand treatment during the study.

    ③using coagulation factor replacement therapy for more than 50 exposure days before screening.

  4. Participants who are enrolled into the Inhibitor Cohort must meet the following criteria:

    ①positive results of inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in screening period.

    ②with ≥6 acute bleeding episodes (spontaneous or traumatic, not including episodes of bleeding during surgery) that required treatment within 6 months before screening and willing to continue to receive on-demand treatment during the study.

  5. Be willing to undergo a washout period of the original treatment regimen before the administration of KN057: at least 48 hours for recombinant activated coagulation factor Ⅶ (rFⅦa); at least 72 hours for FⅧ and prothrombin complex (PCC); at least 96 hours for FⅨ; For other drugs or investigational products with a long half-life, such as Emicizumab, at least five half-lives should have passed prior to dosing.
  6. Be willing to comply with the relevant management regulations of the clinical trial unit, and follow study procedures.

Exclusion Criteria:

  1. Patients with serious or poorly controlled chronic diseases or obvious systemic diseases, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, autoimmune diseases, nervous system diseases or psychiatric diseases, bacterial or viral infections, etc.; past or current lipid-lowering treatment for hypertriglyceridemia.
  2. Inherited or acquired bleeding disorder other than hemophilia A or B.
  3. Have symptoms or signs related to thromboembolic disease or are receiving thrombolytic/anti-thrombolytic therapy; A history of coronary atherosclerotic diseases, arterial or venous thrombosis, and ischemic diseases of important organs.
  4. Conditions that may increase risk of thrombosis: including reduced activity of antithrombin III, protein S or protein C;
  5. Must use PCC to treat acute bleeding episodes, and can't be treated with rFVIIa.
  6. Ongoing or planned use of immune tolerance induction.
  7. Regular use of immunomodulatory therapy, such as regular infusion of immunoglobulin or regular use of hormones.
  8. Allergy situation: Allergic to test drugs/similar drugs or excipients; With a history of multiple allergies (two or more); A history of specific reactions, such as sensitivity to heparin or heparin induced thrombocytopenia.
  9. Abnormal hematologic parameters: Platelet count≤100×10^9/L; Hemoglobin < 100g/L; Fibrinogen level < LLN; Prothrombin time > 1.5 times ULN;
  10. Abnormal renal or hepatic function: Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 times ULN; Lactate dehydrogenase (LDH) > 1.5 times ULN; Total bilirubin (TB) > 1.5 times ULN; Serum creatinine (Cr) and triglyceride > ULN; Albumin < 0.8 times LLN;
  11. Chronic active hepatitis B/C (HBV-DNA or HCV-RNA quantitative test indicates viral activity); Human immunodeficiency virus (HIV) antibody positive; Syphilis antibody positive; Previous antiviral treatment within 1 month, or a plan for antiviral treatment within 28 weeks of initial administration.
  12. Had major surgery, as judged by the investigator, within 3 months prior to the study or have elective surgery planned within 28 weeks of initial administration.
  13. Need to use anti-fibrinolytic drugs or drugs affecting platelet function 5 days before administration or 28 weeks after initial administration, including Traditional Chinese medicine/proprietary Chinese medicine, such as aspirin and other non-steroidal anti-inflammatory drugs, Angelica, astragalus, etc., or proprietary Chinese medicine containing the above ingredients.
  14. Participated in clinical trials related to coagulation factors within 1 month; Participated in any other drug clinical trials within 3 months.
  15. Vaccination within 1 month, or within 28 weeks after initial administration, including inactivated vaccines, live attenuated vaccines, recombinant protein vaccines, recombinant adenovirus vaccines, RNA vaccines, DNA vaccines, etc.;
  16. Subjects with fertile partners are not willing to use effective contraception during the study period and for 3 months after the last dosing; Effective contraceptive methods include: vasectomy, adhere to the scientific use of male condoms, etc.
  17. Other factors that the investigator considers unacceptable for participation in the study.

Sites / Locations

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting
  • stitute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

KN057 (Cohort 1:HA/HB)

KN057 (Cohort 2:HA/HB)

KN057 (Cohort 3:HA/HB)

KN057 (Cohort 4:HAW/HBW)

Arm Description

Injection, once a week

Injection, once a week

Injection, once a week

Injection, once a week

Outcomes

Primary Outcome Measures

Frequency and severity of treatment emergent adverse events(TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. A serious adverse event (SAE) is any untoward medical occurrence at any dose that resulted in death; life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment.
Withdrawals due to TEAEs
An AE is any untoward medical occurrence in a clinical investigation participant administered a product and the event does not need to have a causal relationship with the treatment. TEAEs are AEs occurred following the start of treatment or AEs increasing in severity during treatment.
Number of Participants With Abnormal Laboratory Findings-Hematology
White blood cells, red blood cells; the count of lymphocyte, neutrophils, monocytes, eosinophils, basophils; the percentage of lymphocyte, neutrophils, monocytes, eosinophils, basophils; hemoglobin, red blood cell pressure, platelet count
Number of Participants With Abnormal Laboratory Findings-Urinalysis
blood, urobilirubin, urobiliogen, ketone body, protein, nitrite, red blood cell (qualitative and/or quantitative), white blood cell (qualitative and/or quantitative), pH, urinary glucose.
Number of Participants With Abnormal Laboratory Findings-Blood biochemistry
Total bilirubin and indirect bilirubin, direct bilirubin, alanine aminotransferase, aspertate aminotransferase, GGTP (gamma glutamyl transpeptidase), alkaline phosphatase, total protein, albumin, globulin, albumin-globulin ratio, urea, creatinine, uric acid, glucose, total cholesterol, triglyceride, low density lipoprotein cholesterol (ldl-c), high-density lipoprotein cholesterol (hdl-c), lactate dehydrogenase, creatine kinase, chlorine, calcium, sodium, potassium, C reactive protein
Number of Participants With Abnormal Laboratory Findings-Coagulation tests
Prothrombin time (PT), International Standardized ratio (INR), Activated partial thrombin time (APTT), thrombin time (TT), fibrinogen (FBG/FIB), D-dimer (D-DI), fibrinogen degradation product (FDP), antithrombin - ⅲ (AT- ⅲ)
Number of Participants With Clinically Significant Changes in Vital Signs Data
Vital signs:blood pressure (systolic blood pressure, diastolic blood pressure), respiration, temperature, pulse;
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
ECG: HR; RR; PR; QRS; QT; QTc
Number of Participants With Clinically Significant Changes in Physical Examination Findings
Physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Clinical significance was judged by the investigator.
Number of Participants With Injection Site Reactions
Injection site reactions may include, but are not limited to: erythema, sclerosis, ecchymosis, pain, and itching.

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax) of KN057
Time to Reach Maximum Plasma Concentration (Tmax) of KN057
Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of KN057
Cmax,ss: Maximum observed KN057 concentration at steady-state
Time to Reach Maximum Plasma Concentration at steady-state (Tmax,ss) of KN057
Area Under the Serum Concentration-time Curve Over the Dosing Interval Tau (AUCtau) of KN057
Apparent Clearance (CL/F) of KN057
Lowest Concentration Observed During the Dosing Interval (Cmin) of KN057
Pharmacodynamics index: Changes of TFPI from baseline;
Tissue factor (TF) pathway inhibitor (TFPI) is an anticoagulant protein that inhibits early phases of the procoagulant response. TFPI: Total TFPI, Free TFPI
Pharmacodynamics index: Changes of Prothrombin fragment 1+2 (PF1+2) from baseline;
Prothrombin fragment 1+2 (F1+2) is the amino terminus fragment of the prothrombin molecule.
Pharmacodynamics index: Thrombin Generation (TGA);
Lag Time; Peak Thrombin; Endogenous Thrombin Potential;
Number of Participants Who Tested Positive for Anti-KN057 Antibody (ADA)
Human plasma ADA samples were analyzed for the detection of anti KN057 antibodies.
Number of Participants Who Tested Positive for Neutralizing Antibody (NAb)
Human plasma NAb samples were analyzed for the presence or absence of NAb to KN057.
Annualized Bleeding Rate
ABR = number of bleeds requiring treatments/ (days on treatment period / 365.25)

Full Information

First Posted
June 9, 2022
Last Updated
July 20, 2022
Sponsor
Suzhou Alphamab Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05421429
Brief Title
KN057 Multiple Dose Study in Moderately Severe to Severe Hemophilia
Official Title
An Open, Multicenter, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Subcutaneous (SC) Doses of KN057 in Subjects With Hemophilia A or B, With or Without Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Alphamab Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of multiple subcutaneous doses of KN057 in subjects with hemophilia A or B, with or without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). 24 adult participants 18 to 70 years of age with moderately severe to severe hemophilia A or hemophilia B (defined as FVIII or FIX activity ≤2%, respectively) with or without inhibitors (including 18 HA/HB patients without inhibitors and 6 HA/HB patients with inhibitors) are expected to be enrolled in this study during which they will receive prophylaxis treatment (defined as treatment by SC injection once weekly of KN057).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KN057 (Cohort 1:HA/HB)
Arm Type
Experimental
Arm Description
Injection, once a week
Arm Title
KN057 (Cohort 2:HA/HB)
Arm Type
Experimental
Arm Description
Injection, once a week
Arm Title
KN057 (Cohort 3:HA/HB)
Arm Type
Experimental
Arm Description
Injection, once a week
Arm Title
KN057 (Cohort 4:HAW/HBW)
Arm Type
Experimental
Arm Description
Injection, once a week
Intervention Type
Biological
Intervention Name(s)
KN057 doseⅠ
Intervention Description
KN057 subcutaneous (SC) injection
Intervention Type
Biological
Intervention Name(s)
KN057 dose Ⅱ
Intervention Description
KN057 SC injection
Intervention Type
Biological
Intervention Name(s)
KN057 dose Ⅲ
Intervention Description
KN057 SC injection
Primary Outcome Measure Information:
Title
Frequency and severity of treatment emergent adverse events(TEAEs)
Description
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. A serious adverse event (SAE) is any untoward medical occurrence at any dose that resulted in death; life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment.
Time Frame
Day 1 up to Day 85
Title
Withdrawals due to TEAEs
Description
An AE is any untoward medical occurrence in a clinical investigation participant administered a product and the event does not need to have a causal relationship with the treatment. TEAEs are AEs occurred following the start of treatment or AEs increasing in severity during treatment.
Time Frame
Day 1 up to Day 85
Title
Number of Participants With Abnormal Laboratory Findings-Hematology
Description
White blood cells, red blood cells; the count of lymphocyte, neutrophils, monocytes, eosinophils, basophils; the percentage of lymphocyte, neutrophils, monocytes, eosinophils, basophils; hemoglobin, red blood cell pressure, platelet count
Time Frame
Day 1 up to Day 85
Title
Number of Participants With Abnormal Laboratory Findings-Urinalysis
Description
blood, urobilirubin, urobiliogen, ketone body, protein, nitrite, red blood cell (qualitative and/or quantitative), white blood cell (qualitative and/or quantitative), pH, urinary glucose.
Time Frame
Day 1 up to Day 85
Title
Number of Participants With Abnormal Laboratory Findings-Blood biochemistry
Description
Total bilirubin and indirect bilirubin, direct bilirubin, alanine aminotransferase, aspertate aminotransferase, GGTP (gamma glutamyl transpeptidase), alkaline phosphatase, total protein, albumin, globulin, albumin-globulin ratio, urea, creatinine, uric acid, glucose, total cholesterol, triglyceride, low density lipoprotein cholesterol (ldl-c), high-density lipoprotein cholesterol (hdl-c), lactate dehydrogenase, creatine kinase, chlorine, calcium, sodium, potassium, C reactive protein
Time Frame
Day 1 up to Day 85
Title
Number of Participants With Abnormal Laboratory Findings-Coagulation tests
Description
Prothrombin time (PT), International Standardized ratio (INR), Activated partial thrombin time (APTT), thrombin time (TT), fibrinogen (FBG/FIB), D-dimer (D-DI), fibrinogen degradation product (FDP), antithrombin - ⅲ (AT- ⅲ)
Time Frame
Day 1 up to Day 85
Title
Number of Participants With Clinically Significant Changes in Vital Signs Data
Description
Vital signs:blood pressure (systolic blood pressure, diastolic blood pressure), respiration, temperature, pulse;
Time Frame
Day 1 up to Day 85
Title
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Description
ECG: HR; RR; PR; QRS; QT; QTc
Time Frame
Day 1 up to Day 85
Title
Number of Participants With Clinically Significant Changes in Physical Examination Findings
Description
Physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Clinical significance was judged by the investigator.
Time Frame
Day 1 up to Day 85
Title
Number of Participants With Injection Site Reactions
Description
Injection site reactions may include, but are not limited to: erythema, sclerosis, ecchymosis, pain, and itching.
Time Frame
Day 1 up to Day 85
Secondary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax) of KN057
Time Frame
Day 1 up to Day 8
Title
Time to Reach Maximum Plasma Concentration (Tmax) of KN057
Time Frame
Day 1 up to Day 8
Title
Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of KN057
Time Frame
Day 1 up to Day 8
Title
Cmax,ss: Maximum observed KN057 concentration at steady-state
Time Frame
Day 36 up to Day 43
Title
Time to Reach Maximum Plasma Concentration at steady-state (Tmax,ss) of KN057
Time Frame
Day 36 up to Day 43
Title
Area Under the Serum Concentration-time Curve Over the Dosing Interval Tau (AUCtau) of KN057
Time Frame
Day 36 up to Day 43
Title
Apparent Clearance (CL/F) of KN057
Time Frame
Day 36 up to Day 43
Title
Lowest Concentration Observed During the Dosing Interval (Cmin) of KN057
Time Frame
Day 36 up to Day 43
Title
Pharmacodynamics index: Changes of TFPI from baseline;
Description
Tissue factor (TF) pathway inhibitor (TFPI) is an anticoagulant protein that inhibits early phases of the procoagulant response. TFPI: Total TFPI, Free TFPI
Time Frame
Day 1 up to Day 169
Title
Pharmacodynamics index: Changes of Prothrombin fragment 1+2 (PF1+2) from baseline;
Description
Prothrombin fragment 1+2 (F1+2) is the amino terminus fragment of the prothrombin molecule.
Time Frame
Day 1 up to Day 169
Title
Pharmacodynamics index: Thrombin Generation (TGA);
Description
Lag Time; Peak Thrombin; Endogenous Thrombin Potential;
Time Frame
Day 1 up to Day 169
Title
Number of Participants Who Tested Positive for Anti-KN057 Antibody (ADA)
Description
Human plasma ADA samples were analyzed for the detection of anti KN057 antibodies.
Time Frame
Day 1 up to Day 169
Title
Number of Participants Who Tested Positive for Neutralizing Antibody (NAb)
Description
Human plasma NAb samples were analyzed for the presence or absence of NAb to KN057.
Time Frame
Day 1 up to Day 169
Title
Annualized Bleeding Rate
Description
ABR = number of bleeds requiring treatments/ (days on treatment period / 365.25)
Time Frame
Day 1 up to Day 169

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male, 18-70 years old (including threshold), weight≥40kg; Moderately severe to severe hemophilia A or B (Factor VIII or Factor IX activity ≤2%) Participants who are enrolled into the Non-Inhibitor Cohort must meet the following criteria: ①negtive results of of inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in screening period. ②with ≥6 acute bleeding episodes (spontaneous or traumatic, not including episodes of bleeding during surgery) that required treatment within 6 months before screening and willing to continue to receive on-demand treatment during the study. ③using coagulation factor replacement therapy for more than 50 exposure days before screening. Participants who are enrolled into the Inhibitor Cohort must meet the following criteria: ①positive results of inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in screening period. ②with ≥6 acute bleeding episodes (spontaneous or traumatic, not including episodes of bleeding during surgery) that required treatment within 6 months before screening and willing to continue to receive on-demand treatment during the study. Be willing to undergo a washout period of the original treatment regimen before the administration of KN057: at least 48 hours for recombinant activated coagulation factor Ⅶ (rFⅦa); at least 72 hours for FⅧ and prothrombin complex (PCC); at least 96 hours for FⅨ; For other drugs or investigational products with a long half-life, such as Emicizumab, at least five half-lives should have passed prior to dosing. Be willing to comply with the relevant management regulations of the clinical trial unit, and follow study procedures. Exclusion Criteria: Patients with serious or poorly controlled chronic diseases or obvious systemic diseases, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, autoimmune diseases, nervous system diseases or psychiatric diseases, bacterial or viral infections, etc.; past or current lipid-lowering treatment for hypertriglyceridemia. Inherited or acquired bleeding disorder other than hemophilia A or B. Have symptoms or signs related to thromboembolic disease or are receiving thrombolytic/anti-thrombolytic therapy; A history of coronary atherosclerotic diseases, arterial or venous thrombosis, and ischemic diseases of important organs. Conditions that may increase risk of thrombosis: including reduced activity of antithrombin III, protein S or protein C; Must use PCC to treat acute bleeding episodes, and can't be treated with rFVIIa. Ongoing or planned use of immune tolerance induction. Regular use of immunomodulatory therapy, such as regular infusion of immunoglobulin or regular use of hormones. Allergy situation: Allergic to test drugs/similar drugs or excipients; With a history of multiple allergies (two or more); A history of specific reactions, such as sensitivity to heparin or heparin induced thrombocytopenia. Abnormal hematologic parameters: Platelet count≤100×10^9/L; Hemoglobin < 100g/L; Fibrinogen level < LLN; Prothrombin time > 1.5 times ULN; Abnormal renal or hepatic function: Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 times ULN; Lactate dehydrogenase (LDH) > 1.5 times ULN; Total bilirubin (TB) > 1.5 times ULN; Serum creatinine (Cr) and triglyceride > ULN; Albumin < 0.8 times LLN; Chronic active hepatitis B/C (HBV-DNA or HCV-RNA quantitative test indicates viral activity); Human immunodeficiency virus (HIV) antibody positive; Syphilis antibody positive; Previous antiviral treatment within 1 month, or a plan for antiviral treatment within 28 weeks of initial administration. Had major surgery, as judged by the investigator, within 3 months prior to the study or have elective surgery planned within 28 weeks of initial administration. Need to use anti-fibrinolytic drugs or drugs affecting platelet function 5 days before administration or 28 weeks after initial administration, including Traditional Chinese medicine/proprietary Chinese medicine, such as aspirin and other non-steroidal anti-inflammatory drugs, Angelica, astragalus, etc., or proprietary Chinese medicine containing the above ingredients. Participated in clinical trials related to coagulation factors within 1 month; Participated in any other drug clinical trials within 3 months. Vaccination within 1 month, or within 28 weeks after initial administration, including inactivated vaccines, live attenuated vaccines, recombinant protein vaccines, recombinant adenovirus vaccines, RNA vaccines, DNA vaccines, etc.; Subjects with fertile partners are not willing to use effective contraception during the study period and for 3 months after the last dosing; Effective contraceptive methods include: vasectomy, adhere to the scientific use of male condoms, etc. Other factors that the investigator considers unacceptable for participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanrong Dong, Master
Phone
+86 18914005458
Email
yanrongdong@alphamab.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renchi Yang, Doctor
Organizational Affiliation
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shujie Wang, Doctor
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hu Zhou, Doctor
Organizational Affiliation
Henan Cancer Hospital(The Affiliated Cancer Hospital Of ZhengZhou University)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ziqiang Yu, Doctor
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Changcheng Zheng, Doctor
Organizational Affiliation
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jing Sun, Doctor
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xielan Zhao, Doctor
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renchi Yang, Doctor
Facility Name
stitute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renchi Yang, Doctor

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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KN057 Multiple Dose Study in Moderately Severe to Severe Hemophilia

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