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

NCT04061109 | Unknown Phase 3

• 1 other identifier: CTTQ-NXBYZ-02
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 11

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.

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (2)

• Annualized joint bleeding rate

  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).

  up to 24 weeks

• Incremental Recovery of the First Dose

  Peak activity of FVIII (as Cmax) measured within 1 hour after the end of injection

  After the first dose on day 1

Secondary Outcomes (6)

• Bleeding Event Treatment Efficacy

  up to 24 weeks

• Monthly Average Number of Bleedings

  up to 24 weeks

• The number and dose of injection of Recombinant Human Coagulation FVIII required per bleeding episode

  up to 24 weeks

• Incremental Recovery of Duplicated Dose

  up to 12 weeks, 24 weeks

• Hemophilia Joint Health Score (HJHS)

  Baseline, week 24

Study Arms (1)

Prophylactic therapy

EXPERIMENTAL

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

Interventions

Recombinant Human Coagulation FVIII DRUG

A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.

Prophylactic therapy

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemophilia A.
• FVIII:C \<1%. 3）12 and 65 years old.
• ）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.
• ）Understood and Signed an informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (11)

AnHui Provincial Hospital

Hefei, Anhui, 230001, China

RECRUITING

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

FuJian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

The First Hospital of LanZhou University

Lanzhou, Gansu, 730000, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

HeNan Provincial Peoples Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

HeNan Cancer Provincial Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, 410013, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China

RECRUITING

Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Lei Zhang, Doctor

CONTACT

022-20909240; zhanglei1@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: August 19, 2019
• Study Start: May 15, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

CN (11)