Evidence map›Paper›PMID 26806305›Full record

ArticleActa pharmacologica Sinica2016

Pharmacokinetics and pharmacodynamics of SCT800, a new recombinant FVIII, in hemophilia A mice.

Ruo-lan Gu, Liang Liu, Liang-zhi Xie, Wen-lin Gai, Si-shuo Cao, Zhi-yun Meng, Hui Gan, Zhuo-na Wu, Jian Li, Ying Zheng and 2 more

Abstract read
In one paragraph

Article in Acta pharmacologica Sinica, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Article
  2. [Recent advances in the replacement therapy for Hemophilia].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2023
    Article
  3. Article
  4. 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

12 authors.

Ruo-lan GuState Key Laboratory of Drug Metabolism, Hematological Pharmacology, Beijing Institute of Transfusion Medicine, Beijing 100850, China.
Liang LiuState Key Laboratory of Drug Metabolism, Hematological Pharmacology, Beijing Institute of Transfusion Medicine, Beijing 100850, China.
Liang-zhi XieCell Culture R&D Center, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100005, China.
Wen-lin GaiCell Culture R&D Center, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100005, China.
Si-shuo CaoCell Culture R&D Center, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100005, China.
Zhi-yun MengState Key Laboratory of Drug Metabolism, Hematological Pharmacology, Beijing Institute of Transfusion Medicine, Beijing 100850, China.
Hui GanState Key Laboratory of Drug Metabolism, Hematological Pharmacology, Beijing Institute of Transfusion Medicine, Beijing 100850, China.
Zhuo-na WuState Key Laboratory of Drug Metabolism, Hematological Pharmacology, Beijing Institute of Transfusion Medicine, Beijing 100850, China.
Jian LiState Key Laboratory of Drug Metabolism, Hematological Pharmacology, Beijing Institute of Transfusion Medicine, Beijing 100850, China.
Ying ZhengState Key Laboratory of Drug Metabolism, Hematological Pharmacology, Beijing Institute of Transfusion Medicine, Beijing 100850, China.
Xiao-xia ZhuState Key Laboratory of Drug Metabolism, Hematological Pharmacology, Beijing Institute of Transfusion Medicine, Beijing 100850, China.
Gui-fang DouState Key Laboratory of Drug Metabolism, Hematological Pharmacology, Beijing Institute of Transfusion Medicine, Beijing 100850, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimSCT800 is a new third-generation recombinant FVIII agent that is undergoing promising preclinical study. This study aimed to investigate the pharmacokinetic and pharmacodynamic profiles of SCT800 in hemophilia A mice.

methodsAfter hemophilia A mice were intravenously injected with single dose of SCT800 (80, 180, and 280 IU/kg) or the commercially available product Xyntha (280 IU/kg), pharmacokinetics profiles were evaluated based on measuring plasma FVIII: C. For pharmacodynamics study, dose-response curves of SCT800 and Xyntha (1-200 IU/kg) were constructed using a tail bleeding model monitoring both bleeding time and blood loss.

resultsPharmacokinetics profile analysis showed a dose independency of SCT800 ranging from 80 to 280 IU/kg and comparable pharmacokinetic profiles between SCT800 and Xyntha at the doses tested. Pharmacodynamics study revealed comparable ED50 values of SCT800 and Xyntha in the tail bleeding model: 14.78 and 15.81 IU/kg for bleeding time, respectively; 13.50 and 13.58 IU/kg for blood loss, respectively. Moreover, at the doses tested, the accompanying dose-related safety evaluation in the tail bleeding model showed lower hypercoagulable tendency and wider dosage range potential for SCT800 than Xyntha.

conclusionIn hemophilia A mice, SCT800 shows comparable pharmacokinetics and pharmacodynamics to Xyntha at the doses tested, and possibly with better safety properties.

Indexed as

AnimalsFactor VIIIFemaleHemophilia AHemorrhageMaleMiceMice, Inbred C57BLRecombinant ProteinsF8 protein, humanFactor VIIIRecombinant Proteins

Identifiers

PMID26806305
PMCPMC4775845

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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.