search
Back to results

A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A

Primary Purpose

Hemophilia A

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Adynovate
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia A

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Participant and/or legally authorized representative must voluntarily sign a written informed consent form (ICF) after all relevant aspects of the study have been explained and discussed with the Participant. For the participants less than (<) 18 years old, participants will give assent AND their parents/legally authorized representative should sign the ICF accordingly. Participant and/or legally authorized representative understands and is willing and able to comply with all requirements of the study protocol. Participant should be ethnic Chinese. Participant is 12 to 65 years of age at screening and male. Participant has severe hemophilia A (FVIII clotting activity <1 percent [%]) as confirmed by the central laboratory at screening after a washout period of at least 72 to 96 hours. The last on-demand or prophylactic treatment received is within 3 months before screening. Participant has documented previous treatment with plasma-derived FVIII concentrates or recombinant FVIII for greater than (>) 150 EDs. Participant is human immunodeficiency virus (HIV)-negative, or HIV-positive with stable disease and CD4+ count greater than or equal to (>=) 200 cells per cubic millimeter (/mm^3). Participant is hepatitis C virus (HCV) negative by antibody testing (if positive, additional polymerase chain reaction testing will be performed to confirm), as confirmed at screening; or HCV-positive with chronic stable hepatitis, as assessed by the investigator. Exclusion Criteria: Participant has detectable FVIII inhibitory antibodies (>=0.6 Bethesda units [BU] per milliliter [/mL] using the Nijmegen modification of the Bethesda assay) as confirmed by the central laboratory at screening. Participant has a confirmed history of FVIII inhibitory antibodies (>=0.6 BU using the Nijmegen modification of the Bethesda assay or >=0.6 BU using the Bethesda assay) at any time prior to screening. Participant has a known hypersensitivity to Adynovate or ADVATE or any of the components of the study drugs, such as mouse or hamster proteins, or other FVIII products. Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (example, qualitative platelet defect or von Willebrand's disease). Participant has severe hepatic dysfunction (example, >=5 times the upper limit of normal [ULN] for alanine aminotransferase [ALT] or aspartate aminotransferase [AST], a recent or persistent international normalized ratio [INR] >1.5, as confirmed by the local laboratory at screening). Participant has severe renal impairment (serum creatinine >1.5 times the ULN) as confirmed by the local laboratory at screening. Participant is planned or likely to undergo major surgery during the study period. Participant has current or recent (<30 days) use of other PEGylated drugs before study participation or scheduled use of such drugs during study participation. Participant has received emicizumab therapy within 6 months of screening. Participant is currently receiving, or scheduled to receive during the study, an immunomodulating drug (example, systemic corticosteroid agent at a dose equivalent to hydrocortisone >10 milligram per day [mg/day], or alpha-interferon) other than antiretroviral chemotherapy. Participant has participated in another clinical study involving the use of an investigational product (IP) other than Adynovate or an investigational device within 30 days before the screening visit or is scheduled to participate in another clinical study involving an IP or investigational device during this study. Participant has a medical, psychiatric, or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance. Participant, in the opinion of the investigator, is unable or unwilling to comply with the study protocol.

Sites / Locations

  • Beijing Children's Hospital, Capital Medical UniversityRecruiting
  • Peking Union Medical College Hospital, Chinese Academy of Medical SciencesRecruiting
  • Xiangya Hospital of Central South University
  • Fujian Medical University Union Hospital
  • Nanfang Hospital Southern Medical UniversityRecruiting
  • Anhui Province Hospital
  • Jinan Central HospitalRecruiting
  • Shenzhen Second People's HospitalRecruiting
  • The First Affiliated Hospital of Soochow University
  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesRecruiting
  • Tongji Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adynovate 45±5 IU/kg

Arm Description

Participants will receive prophylactic treatment with Adynovate (45 [±5] international units per kilogram [IU/kg]), infusion, intravenously, twice-weekly, over a period of 26 weeks or at least 50 EDs, whichever occurs last.

Outcomes

Primary Outcome Measures

Total Annualized Bleeding Rates (ABR)
Total ABR for all bleeding episodes, spontaneous or traumatic, recorded in the participant's electronic diary and/or recorded in the physician/nurse/study site notes will be reported.

Secondary Outcome Measures

ABR Based on Bleeding Site and Cause
Number of Adynovate Infusions per Week During the Prophylactic Treatment Period
Number of Adynovate Infusions per Month During the Prophylactic Treatment Period
Weight-adjusted Consumption of Adynovate per Week During the Prophylactic Treatment Period
Weight-adjusted Consumption of Adynovate per Month During the Prophylactic Treatment Period
Percentage of Participants With Zero Bleeding Episodes During the Study
Time Intervals Between Bleeding Episodes
Overall Hemostatic Efficacy Rating at Bleed Resolution for Treatment of Breakthrough Bleeding Episodes
Number of Adynovate Infusions per Bleeding Episode
Weight-adjusted Consumption of Adynovate per Bleeding Episode
Number of Minor Surgeries With Hemostatic Efficacy Response Based on Global Hemostatic Efficacy Assessment (GHEA) Score as Assessed by the Operating Surgeon/Investigator
GHEA score consists of 3 individual rating scales: (1) Intra-operative Efficacy Assessment Scale, (2) Post-operative Efficacy Assessment Scale, and (3) Peri-operative Efficacy Assessment Scale. Each rating scale is based on 4 points scale ranging from: 3 (Excellent), 2 (Good), 1 (Fair), and 0 (None). Total score ranged from 0 to 9, where scores evaluates as: excellent (7 to 9), good (5 to 7), fair (3 to 4), and none (0 to 2). The scores of 3 individual ratings scales will be added together to form a GHEA score. For a GHEA score of 7 to be rated "excellent" with no individual assessment scores less than (<) 2 and at least 1 assessment score equal to (=) 3; otherwise a score of 7 will be rated "good".
Volume of Actual and Predicted Intra-operative and Post-operative Blood Loss After the Surgery as Assessed by the Operating Surgeon/Investigator
Number of Participants who Require Perioperative Transfusion of Blood, Red blood Cells, Platelets, and Other Blood Products
Daily Intra-Operative and Post-Operative Weight-Adjusted Consumption Dose of Adynovate
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs will include TEAEs by severity, TEAEs by causality, thromboembolic events, hypersensitivity reactions, any clinically significant changes in vital signs and clinical laboratory parameters.
Number of Participants With Confirmed Inhibitory Antibodies to Factor VIII (FVIII), Binding Antibodies to Adynovate and Chinese Hamster Ovary (CHO) Protein
FVIII Activity Level in Plasma Assessed by a 1-stage Clotting Assay
Incremental Recovery Over Time During Adynovate Prophylactic Treatment
Pre-dose Level of FVIII Activity and Antigen and von Willebrand Factor (VWF) Antigen in Plasma
Clearance (CL) for FVIII Activity Following an Initial Single Dose and Steady-state Dose of Adynovate
Volume of Distribution (V) for FVIII Activity Following an Initial Single Dose and Steady-state Dose of Adynovate
Area Under the Concentration Versus Time Curve From 0 to 96 Hours (AUC0-96) for FVIII Activity Following an Initial Single Dose and Steady-state Dose of Adynovate
Maximum Concentration (Cmax) for FVIII Activity Following an Initial Single Dose and Steady-state Dose of Adynovate
Pre-dose Concentration (Cpredose) for FVIII Activity Following an Initial Single Dose and Steady-state Dose of Adynovate
Terminal Phase Elimination Half-life (T1/2) for FVIII Activity Following an Initial Single Dose and Steady-state Dose of Adynovate

Full Information

First Posted
January 23, 2023
Last Updated
June 1, 2023
Sponsor
Takeda
search

1. Study Identification

Unique Protocol Identification Number
NCT05707351
Brief Title
A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A
Official Title
A Phase 3, Prospective, Multicenter, Open-label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (ADYNOVATE) Administered for Prophylaxis and Treatment of Bleeding in Chinese Previously Treated Patients With Severe Hemophilia A (FVIII <1%)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

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
The main aim of the study is to determine how well Adynovate works to decrease bleeding in previously treated Chinese men and boys with severe hemophilia A when given prophylactically. Participants will be treated with Adynovate twice a week for 26 weeks or until participants have received 50 days of treatment with Adynovate (whichever takes longer). Participants will need to visit their study clinic several times during their participation.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adynovate 45±5 IU/kg
Arm Type
Experimental
Arm Description
Participants will receive prophylactic treatment with Adynovate (45 [±5] international units per kilogram [IU/kg]), infusion, intravenously, twice-weekly, over a period of 26 weeks or at least 50 EDs, whichever occurs last.
Intervention Type
Biological
Intervention Name(s)
Adynovate
Other Intervention Name(s)
Antihemophilic Factor (recombinant) PEGylated, Rurioctocog Alfa Pegol
Intervention Description
Adynovate will be injected intravenously using an appropriately sized syringe as a bolus infusion over a period of less than or equal to (<=) 5 minutes (maximum infusion rate, 10 milliliters per minute [mL/min]).
Primary Outcome Measure Information:
Title
Total Annualized Bleeding Rates (ABR)
Description
Total ABR for all bleeding episodes, spontaneous or traumatic, recorded in the participant's electronic diary and/or recorded in the physician/nurse/study site notes will be reported.
Time Frame
Baseline up to Week 26
Secondary Outcome Measure Information:
Title
ABR Based on Bleeding Site and Cause
Time Frame
Baseline up to Week 26
Title
Number of Adynovate Infusions per Week During the Prophylactic Treatment Period
Time Frame
Baseline up to Week 26
Title
Number of Adynovate Infusions per Month During the Prophylactic Treatment Period
Time Frame
Baseline up to Week 26
Title
Weight-adjusted Consumption of Adynovate per Week During the Prophylactic Treatment Period
Time Frame
Baseline up to Week 26
Title
Weight-adjusted Consumption of Adynovate per Month During the Prophylactic Treatment Period
Time Frame
Baseline up to Week 26
Title
Percentage of Participants With Zero Bleeding Episodes During the Study
Time Frame
Baseline up to Week 26
Title
Time Intervals Between Bleeding Episodes
Time Frame
Baseline up to Week 26
Title
Overall Hemostatic Efficacy Rating at Bleed Resolution for Treatment of Breakthrough Bleeding Episodes
Time Frame
Baseline up to Week 26
Title
Number of Adynovate Infusions per Bleeding Episode
Time Frame
Baseline up to Week 26
Title
Weight-adjusted Consumption of Adynovate per Bleeding Episode
Time Frame
Baseline up to Week 26
Title
Number of Minor Surgeries With Hemostatic Efficacy Response Based on Global Hemostatic Efficacy Assessment (GHEA) Score as Assessed by the Operating Surgeon/Investigator
Description
GHEA score consists of 3 individual rating scales: (1) Intra-operative Efficacy Assessment Scale, (2) Post-operative Efficacy Assessment Scale, and (3) Peri-operative Efficacy Assessment Scale. Each rating scale is based on 4 points scale ranging from: 3 (Excellent), 2 (Good), 1 (Fair), and 0 (None). Total score ranged from 0 to 9, where scores evaluates as: excellent (7 to 9), good (5 to 7), fair (3 to 4), and none (0 to 2). The scores of 3 individual ratings scales will be added together to form a GHEA score. For a GHEA score of 7 to be rated "excellent" with no individual assessment scores less than (<) 2 and at least 1 assessment score equal to (=) 3; otherwise a score of 7 will be rated "good".
Time Frame
Baseline up to Week 26
Title
Volume of Actual and Predicted Intra-operative and Post-operative Blood Loss After the Surgery as Assessed by the Operating Surgeon/Investigator
Time Frame
Post-operative: Day 1 and at discharge Week 26
Title
Number of Participants who Require Perioperative Transfusion of Blood, Red blood Cells, Platelets, and Other Blood Products
Time Frame
Baseline up to Week 26
Title
Daily Intra-Operative and Post-Operative Weight-Adjusted Consumption Dose of Adynovate
Time Frame
Baseline up to Week 26
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
TEAEs will include TEAEs by severity, TEAEs by causality, thromboembolic events, hypersensitivity reactions, any clinically significant changes in vital signs and clinical laboratory parameters.
Time Frame
Screening up to Week 26
Title
Number of Participants With Confirmed Inhibitory Antibodies to Factor VIII (FVIII), Binding Antibodies to Adynovate and Chinese Hamster Ovary (CHO) Protein
Time Frame
Screening up to Week 26
Title
FVIII Activity Level in Plasma Assessed by a 1-stage Clotting Assay
Time Frame
Baseline and Week 20: 0-96 hours post-infusion
Title
Incremental Recovery Over Time During Adynovate Prophylactic Treatment
Time Frame
Baseline up to Week 26
Title
Pre-dose Level of FVIII Activity and Antigen and von Willebrand Factor (VWF) Antigen in Plasma
Time Frame
Baseline up to Week 26: Within 30 minutes pre-infusion
Title
Clearance (CL) for FVIII Activity Following an Initial Single Dose and Steady-state Dose of Adynovate
Time Frame
Baseline and Week 20: 0-96 hours post-infusion
Title
Volume of Distribution (V) for FVIII Activity Following an Initial Single Dose and Steady-state Dose of Adynovate
Time Frame
Baseline and Week 20: 0-96 hours post-infusion
Title
Area Under the Concentration Versus Time Curve From 0 to 96 Hours (AUC0-96) for FVIII Activity Following an Initial Single Dose and Steady-state Dose of Adynovate
Time Frame
Baseline and Week 20: 0-96 hours post-infusion
Title
Maximum Concentration (Cmax) for FVIII Activity Following an Initial Single Dose and Steady-state Dose of Adynovate
Time Frame
Baseline and Week 20: 0-96 hours post-infusion
Title
Pre-dose Concentration (Cpredose) for FVIII Activity Following an Initial Single Dose and Steady-state Dose of Adynovate
Time Frame
Baseline and Week 20: Within 30 minutes pre-infusion
Title
Terminal Phase Elimination Half-life (T1/2) for FVIII Activity Following an Initial Single Dose and Steady-state Dose of Adynovate
Time Frame
Baseline and Week 20: 0-96 hours post-infusion

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant and/or legally authorized representative must voluntarily sign a written informed consent form (ICF) after all relevant aspects of the study have been explained and discussed with the Participant. For the participants less than (<) 18 years old, participants will give assent AND their parents/legally authorized representative should sign the ICF accordingly. Participant and/or legally authorized representative understands and is willing and able to comply with all requirements of the study protocol. Participant should be ethnic Chinese. Participant is 12 to 65 years of age at screening and male. Participant has severe hemophilia A (FVIII clotting activity <1 percent [%]) as confirmed by the central laboratory at screening after a washout period of at least 72 to 96 hours. The last on-demand or prophylactic treatment received is within 3 months before screening. Participant has documented previous treatment with plasma-derived FVIII concentrates or recombinant FVIII for greater than (>) 150 EDs. Participant is human immunodeficiency virus (HIV)-negative, or HIV-positive with stable disease and CD4+ count greater than or equal to (>=) 200 cells per cubic millimeter (/mm^3). Participant is hepatitis C virus (HCV) negative by antibody testing (if positive, additional polymerase chain reaction testing will be performed to confirm), as confirmed at screening; or HCV-positive with chronic stable hepatitis, as assessed by the investigator. Exclusion Criteria: Participant has detectable FVIII inhibitory antibodies (>=0.6 Bethesda units [BU] per milliliter [/mL] using the Nijmegen modification of the Bethesda assay) as confirmed by the central laboratory at screening. Participant has a confirmed history of FVIII inhibitory antibodies (>=0.6 BU using the Nijmegen modification of the Bethesda assay or >=0.6 BU using the Bethesda assay) at any time prior to screening. Participant has a known hypersensitivity to Adynovate or ADVATE or any of the components of the study drugs, such as mouse or hamster proteins, or other FVIII products. Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (example, qualitative platelet defect or von Willebrand's disease). Participant has severe hepatic dysfunction (example, >=5 times the upper limit of normal [ULN] for alanine aminotransferase [ALT] or aspartate aminotransferase [AST], a recent or persistent international normalized ratio [INR] >1.5, as confirmed by the local laboratory at screening). Participant has severe renal impairment (serum creatinine >1.5 times the ULN) as confirmed by the local laboratory at screening. Participant is planned or likely to undergo major surgery during the study period. Participant has current or recent (<30 days) use of other PEGylated drugs before study participation or scheduled use of such drugs during study participation. Participant has received emicizumab therapy within 6 months of screening. Participant is currently receiving, or scheduled to receive during the study, an immunomodulating drug (example, systemic corticosteroid agent at a dose equivalent to hydrocortisone >10 milligram per day [mg/day], or alpha-interferon) other than antiretroviral chemotherapy. Participant has participated in another clinical study involving the use of an investigational product (IP) other than Adynovate or an investigational device within 30 days before the screening visit or is scheduled to participate in another clinical study involving an IP or investigational device during this study. Participant has a medical, psychiatric, or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance. Participant, in the opinion of the investigator, is unable or unwilling to comply with the study protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Children's Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613911383480
Email
wurunhuigcp@163.com
First Name & Middle Initial & Last Name & Degree
Wu Runhui
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8618611743292
Email
zhutn@pumch.cn
First Name & Middle Initial & Last Name & Degree
Tienan Zhu
Facility Name
Xiangya Hospital of Central South University
City
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613707489198
Email
zhaox19198@163.com
First Name & Middle Initial & Last Name & Degree
Xielan Zhao
First Name & Middle Initial & Last Name & Degree
Yajing Xu
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613365910312
Email
yangfenge2016@163.com
First Name & Middle Initial & Last Name & Degree
Yang Fenge
Facility Name
Nanfang Hospital Southern Medical University
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613316202696
Email
jsun_cn@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sun Jing
Facility Name
Anhui Province Hospital
City
Hefei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8618956073079
Email
zhengchch1123@163.com
First Name & Middle Initial & Last Name & Degree
Changcheng Zheng
Facility Name
Jinan Central Hospital
City
Jinan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613370582720
Email
chyun66@126.com
First Name & Middle Initial & Last Name & Degree
Chen Yun
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613602523722
Email
duxingz@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Du Xin
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613913518032
Email
yuziqiang@suda.edu.cn
First Name & Middle Initial & Last Name & Degree
Yu Ziqiang
Facility Name
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613512078851
Email
rcyang65@163.com
First Name & Middle Initial & Last Name & Degree
Yang Renchi
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8618971353983
Email
qunhu2013@163.com
First Name & Middle Initial & Last Name & Degree
Hu Qun
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613986183871
Email
dr_huyu@126.com
First Name & Middle Initial & Last Name & Degree
Hu Yu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/46da5667215042fa?idFilter=%5B%22TAK-660-3001%22%5D
Description
To obtain more information on the study, click here/on this link

Learn more about this trial

A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A

We'll reach out to this number within 24 hrs