Evidence map›Paper›PMID 35996199›Full record

Trial reportHaemophilia : the official journal of the World Federation of Hemophilia2022

Efficacy, safety and bioequivalence of the human-derived B-domain-deleted recombinant factor VIII TQG202 for prophylaxis in severe haemophilia A patients.

Yaming Xi, Chenghao Jin, Wei Liu, Hu Zhou, Zhen Wang, Rongfu Zhou, Shifeng Lou, Xielan Zhao, Fangping Chen, Peng Cheng and 3 more

Open access · greenAbstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Haemophilia : the official journal of the World Federation of Hemophilia, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. The therapeutic landscape of inherited bleeding disorders in China.Research and practice in thrombosis and haemostasis · 2026
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 12 institutions in 1 country.

Yaming XiDepartment of Hematology, The First Hospital of Lanzhou University, Lanzhou, Gansu Province, China.
Chenghao JinHemophilia Information Management Center of Jiangxi Province, Jiangxi Provincial People's Hospital, Nanchang, China.
Wei LiuState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital,Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.
Hu ZhouDepartment of Hematology, The Cancer Hospital affiliated to Zhengzhou University, Zhengzhou, China.
Zhen WangDepartment of Hematology, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, China.
Rongfu ZhouDepartment of Hematology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.
Shifeng LouDepartment of Hematology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China.
Xielan ZhaoDepartment of Hematology, Xiangya Hemophilia Diagnosis and Treatment Center, Xiangya Hospital, Central South University, Changsha, Hunan Province, China.
Fangping ChenDepartment of Hematology, Xiangya Hemophilia Diagnosis and Treatment Center, Xiangya Hospital, Central South University, Changsha, Hunan Province, China.
Peng ChengDepartment of Hematology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi Province, China.
Zimin SunDepartment of Hematology, The Affiliated Provincial Hospital of Anhui Medical University, Hefei, China.
Haifei JiaR&D Institute, Chia Tai Tianqing Pharmaceutical Group Co. Ltd., Nanjing, Jiangsu Province, China.
Lei ZhangState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital,Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.
Institute of Hematology & Blood Diseases Hospital · CNAnhui Provincial Hospital · CNCentral South University · CNChina Design Group (China) · CNGuangxi Medical University · CNJiangxi Provincial People's Hospital · CNLanzhou University · CNNanjing Drum Tower Hospital · CNSecond Affiliated Hospital of Chongqing Medical University · CNXiangya Hospital Central South University · CNZhengzhou People's Hospital · CNZhengzhou University · CN

Funding

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
6 · The paper itself

Abstract

introductionCurrent treatment of severe haemophilia A includes prophylaxis with factor VIII (FVIII) replacement. The supply of plasma-derived FVIII is short in China. PURPOSE: To evaluate the efficacy and safety of a new B-domain deleted (BDD) recombinant FVIII (TQG202) produced by human-derived cells for prophylaxis in severe haemophilia A patients and compare the bioequivalence with Xyntha.

methodsThis multicentre, clinical trial consisted of an open-label, randomized, two-period cross-over trial assessing single-dose pharmacokinetics (PK), and a single-arm clinical trial evaluating the efficacy and safety of 24 weeks of TQG202 prophylaxis, and repeated PK were assessed after prophylaxis phase. The single-dose was 50 IU/kg in PK assessment, and the initial dose was 30 ± 5 IU/kg for prophylaxis. The primary endpoints of prophylaxis were the annualized bleeding rate (ABR) and the incremental recovery rate of the first administration. Adverse events (AEs) were recorded.

resultsTwenty-six participants were enrolled in the PK assessment and 81 participants in the prophylaxis phase. Mean age was 25.9 ± 10.8 years and all participants were male. The results of PK assessment showed TQG202 is bioequivalent to Xyntha. The total ABR was 2.0 (95% CI: 1.2-2.9) in prophylaxis phase. The mean incremental recovery rate of the first administration was .027 (95% CI: .026-.028) (IU/ml)/(IU/kg). AEs occurred in 42 participants, with an incidence of 51.9%. One severe AE not related to TQG202 occurred. No participants developed FVIII inhibitors.

conclusionTQG202 shows bioequivalence with Xyntha. The promising efficacy and tolerability in the severe haemophilia A prophylaxis support the use of TQG202in clinical practice.

Indexed as

Hemophilia AHemostaticsAdolescentAdultFactor VIIIHemorrhageHumansMaleTherapeutic EquivalencyYoung AdultF8 protein, humanFactor VIIIHemostaticsfactor VIII, haemophilia Apharmacokineticsprophylaxisrecombinanttreatment

Identifiers

PMID35996199
OpenAlexW4292986626

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.