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ACTIVE NOT RECRUITING
NCT06297655
PHASE3

A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A

Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a single arm, open, multicenter clinical trial in which the previous treated severe hemophilia A patients receive recombinant human coagulation factor VIII for injection to evaluate the efficacy and safety of on-demand treatment in the event of new bleeding events. If evaluable surgical cases occur, the overall efficacy and safety of recombinant human coagulation factor VIII for injection as a replacement therapy for severe hemophilia A PTPs during the perioperative period will be evaluated.

Official title: A Phase III Clinical Study Evaluating the Efficacy and Safety of On-demand Treatment and Perioperative Replacement Therapy With Recombinant Human Coagulation Factor VIII for Injection in Treated Severe Hemophilia A

Key Details

Gender

All

Age Range

12 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-11-12

Completion Date

2026-07

Last Updated

2026-06-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

Recombinant human activated coagulation factor VIII for injection

Recombinant human coagulation factor VIII for injection is a recombinant DNA product with functional characteristics comparable to endogenous factor VIII.

Locations (12)

Fuyang Hospital Affiliated to Anhui Medical University

Fuyang, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Henan Tumor Hospital

Zhengzhou, Henan, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Nanjing Drug Tower Hospital

Nanjing, Jiangsu, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Hematology Hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China