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Safety, Efficacy Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04061109
Recruitment Status : Unknown
Verified August 2019 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..
Recruitment status was:  Recruiting
First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study Description
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Brief Summary:
This is a multi-center, open-label, single-arm trial to evaluate the efficacy and safety of Recombinant Coagulation Factor VIII in patients with hemophilia A . Recombinant Coagulation Factor VIII is prophylactic administrated 25 - 35 IU/kg once every other day or three times per week which should be continuous for 24 weeks.

Condition or disease Intervention/treatment Phase
Hemophilia A Drug: Recombinant Human Coagulation FVIII Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multicenter, Noncontrol Study of Recombinant Coagulation Factor VIII for Prophylactic Therapy in Subjects With Hemophilia A.
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Prophylactic therapy
Subjects received Recombinant Human Coagulation FVIII for prophylactic therapy with 25 - 35 IU/kg injection once every other day or three times per week for 6 months.
 Drug: Recombinant Human Coagulation FVIII
A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.


Outcome Measures
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Primary Outcome Measures :
  1. Annualized joint bleeding rate [ Time Frame: up to 24 weeks ]
    Annualized joint bleeding rate（AJBR） can be calculated using the following formula: Number of joint bleeding events during efficacy evaluation period/(number of days in treatment period/365.25).

  2. Incremental Recovery of the First Dose [ Time Frame: After the first dose on day 1 ]
    Peak activity of FVIII (as Cmax) measured within 1 hour after the end of injection


Secondary Outcome Measures :
  1. Bleeding Event Treatment Efficacy [ Time Frame: up to 24 weeks ]
    The investigator shall evaluate the hemostatic effect after the treatment of every bleeding event of subjects based on a four-point scale(excellent, good, moderate, not relieved).

  2. Monthly Average Number of Bleedings [ Time Frame: up to 24 weeks ]
    Number of bleeding events in each month.

  3. The number and dose of injection of Recombinant Human Coagulation FVIII required per bleeding episode [ Time Frame: up to 24 weeks ]
    The number and dose of injection of Recombinant Human Coagulation FVIII required per bleeding episode

  4. Incremental Recovery of Duplicated Dose [ Time Frame: up to 12 weeks, 24 weeks ]
    Peak activity of FVIII (as Cmax) measured within 1 hour after the end of injection.

  5. Hemophilia Joint Health Score (HJHS) [ Time Frame: Baseline, week 24 ]
    The scale assesses the functional status of the six major joints of the elbow, knee, and ankle, including: joint swelling, swelling duration, muscle atrophy, muscle strength, joint friction, joint pain, joint extension, joint flexion Degree decline, overall gait, etc.

  6. Assess the impact of Recombinant Human Coagulation FVIII following Patient Reported Outcome (PRO) EQ-5D [ Time Frame: Baseline, week 24 ]
    EQ-5D is a general questionnaire designed to measure health status on a scale of 0-100 with the higher value representing a better outcome and record the participants' current health state in 5 domains mobility, selfcare, usual activities, pain, anxiety.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Hemophilia A.
  2. FVIII:C <1%. 3）12 and 65 years old.

4）Has received FVIII treatment and the treatment exposure days ≥100. 5）Has bleeding treatment records of at least 3 months before randomization. 6）FVIII inhibitor assay results is negative. 7） Subjects should agree to use an adequate method of contraception during the study.

8）Understood and Signed an informed consent form.

Exclusion Criteria:

  1. Has a history or family history of blood coagulation factor VIII inhibitor.
  2. Has other coagulation dysfunction diseases in addition to hemophilia A.
  3. HIV positive.
  4. Plan to receive surgery during the trial.
  5. Has used immunomodulator within one weeks before the first dose，and less than 7 half-life periods.
  6. Known to be allergic to experimental drugs or any excipients.
  7. Severe anemia and need blood transfusion.
  8. Serious liver or kidney damage.
  9. Serious heart disease.
  10. Uncontrollable hypertension.
  11. Has participated in other clinical studies within one month before the first dose.
  12. The researchers believe that it is not suitable for participants.
Contacts and Locations
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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): NCT04061109


Contacts
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Contact: Lei Zhang, Doctor 022-20909240 zhanglei1@ihcams.ac.cn

Locations
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China, Anhui
AnHui Provincial Hospital Recruiting
Hefei, Anhui, China, 230001
Contact: Zimin Sun, Doctor    0551 -62283191    zmsun_vip@163.com   
Principal Investigator: Zimin Sun         
China, Chongqing
The Second Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China, 400010
Contact: Shifeng Lou, Master    023-62887783    13508331213@163.com   
Principal Investigator: Shifeng Lou         
China, Fujian
FuJian Medical University Union Hospital Recruiting
Fuzhou, Fujian, China, 350001
Contact: Meijuan Huang, D    0591-86218041    huangmj163@163.com   
Principal Investigator: Meijuan Huang         
China, Gansu
The First Hospital of LanZhou University Recruiting
Lanzhou, Gansu, China, 730000
Contact: Yaming Xi, Doctor    0931-8356266    xiyaming@163.com   
Principal Investigator: Yaming Xi         
China, Guangxi
The First Affiliated Hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China, 530021
Contact: Peng Cheng, Master    0771-12580    13977166448@163.com   
Principal Investigator: Peng Cheng         
China, Henan
HeNan Provincial Peoples Hospital Recruiting
Zhengzhou, Henan, China, 450003
Contact: Zhen Wang, Doctor    0371-65896920    jenny1983218@126.com   
Principal Investigator: Zhen Wang         
HeNan Cancer Provincial Hospital Recruiting
Zhengzhou, Henan, China, 450008
Contact: Hu Zhou, Doctor    0371-65587278    papertigerhu@163.com   
Principal Investigator: Hu Zhou         
China, Hunan
Xiangya Hospital Central South University Recruiting
Changsha, Hunan, China, 410013
Contact: Xielan Zhao, Doctor    0731-84327564    zhaoxl9198@163.com   
Principal Investigator: Xielan Zhao         
China, Jiangsu
Nanjing Drum Tower Hospital Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Rongfu Zhou, Doctor    83106666-61441    rfzhoucn@163.com   
Principal Investigator: Rongfu Zhou         
China, Jiangxi
Jiangxi Provincial People's Hospital Recruiting
Nanchang, Jiangxi, China, 330006
Contact: Chenghao Jin, Doctor    0791-86895612    Jinch227@aliyun.com   
Principal Investigator: Chenghao Jin         
China, Tianjin
Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences Recruiting
Tianjin, Tianjin, China, 300020
Contact: Lei Zhang, Doctor    022-20909240    zhanglei1@ihcams.ac.cn   
Principal Investigator: Lei Zhang         
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
More Information
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT04061109    
Other Study ID Numbers: CTTQ-NXBYZ-02
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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