[Translation] An open, self-controlled, multicenter clinical study to evaluate the efficacy and safety of human fibrinogen in the treatment of congenital fibrinogen deficiency or deficiency

评价人纤维蛋白原治疗先天性纤维蛋白原减少或缺乏症的有效性及安全性，为注册申报生产提供依据。

[Translation]

To evaluate the effectiveness and safety of human fibrinogen in treating congenital fibrinogen deficiency or deficiency, and provide a basis for registration and production application.

Start Date16 Aug 2018

Sponsor / Collaborator

Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.

100 Clinical Results associated with Human Fibrinogen (Guangdong Shuanglin Biological Pharmaceutical)

100 Translational Medicine associated with Human Fibrinogen (Guangdong Shuanglin Biological Pharmaceutical)

100 Patents (Medical) associated with Human Fibrinogen (Guangdong Shuanglin Biological Pharmaceutical)

Literatures (Medical) associated with Human Fibrinogen (Guangdong Shuanglin Biological Pharmaceutical)

01 Aug 1986·Journal of Bone and Mineral ResearchQ1 · MEDICINE

Serum bone GLA-protein in growth hormone deficient children

Q1 · MEDICINE

Article

Author: Pierre D. Delmas ; Graziela Bonne ; Pierre Chatelain ; Luc Malaval

AbstractSerum bone GLA-protein (BGP), a sensitive and specific marker of bone formation, was measured in 54 normal children and in 50 children with growth disorders. In normal children, the pattern of variations of serum BGP with age was similar to the pattern of variations of the growth velocity. Mean serum BGP was very high during the first year of life (25.3 ± 8.5 ng/ml), decreased to 14.8 ± 2.2 ng/ml from 2 to 6 years, increased to 18.4 ± 4.1 ng/ml from 7 to 10 years and to 18.8 ± 6.5 ng/ml from 11 to 14 years. After puberty, mean sBGP decreased to 12.9 ± 5.4 ng/ml from 15 to 18 years and to 6.5 ± 1.4 ng/ml in young adults. In 32 patients with untreated growth hormone (GH) deficiency, mean sBGP was markedly lower than in age matched controls (6.8 ± 4.4 ng/ml vs. 17.5 ± 4.9 ng/ml, p < .001). In 19 patients with GH deficiency who were undergoing treatment with human GH, sBGP was higher than in untreated patients (20.5 ± 9.3 ng/ml vs. 6.8 ± 4.4 ng/ml, p < .001) and was not different from controls. Repeated measurements performed in 14 GH-deficient patients under chronic GH therapy showed that serum BGP: (1) increased in most patients during treatment (p < .005); (2) was correlated with the duration of treatment (p < .001); (3) decreased to pretreatment values after discontinuing therapy. In conclusion, our data suggest that serum BGP is a sensitive marker of skeletal growth in normal children and in children with growth deficiency, and that measurement of serum BGP might be useful to assess the effects on bone metabolism of hormones and/or drugs that stimulate bone growth and maturation.

01 Jun 1981·EndocrinologyQ2 · MEDICINE

Differential Effects of Hypothyroidism on the Specific Uptake of Growth Hormone and Prolactin by the Rat Liver*

Q2 · MEDICINE

Article

Author: Duran-Garcia, S. ; Escobar del Rey, F. ; Obregon, M. J. ; Morreale de Escobar, G.

The possible effects of severe hypothyroidism on the specific uptake of ovine PRL (oPRL) and bovine GH (bGH) by the liver have been investigated in the rat. Female rats were thyroidectomized (T). These animals and age-paired controls (C) were injected with less than 20 ng [125I]iodo-oPRL or [125I]iodo-bGH alone or in combination with 100-200 micrograms native oPRL, bGH, or human GH per 100 g BW. The animals were killed at different intervals, and the total 125I was determined in plasma and liver. From these data, the liver to plasma 125I ratio was calculated. In some experiments the proportion of 125I which was soluble in 10% trichloroacetic acid was also determined. The T rats were all severely hypothyroid. A specific uptake of [125I]iodo-oPRL by the liver could be shown for C rats. It was, however, markedly decreased in T rats (in agreement with previous findings showing a decrease of liver lactogenic binding sites) studied in vitro. On the contrary, the specific liver uptake of [125I]iodo-bGH was not decreased in T rats. Some differences were, however, observed between T and C rats with respect to saturation of the liver uptake of bGH and the metabolism of the [125I]iodo-bGH. The amount of native bGH required to reduce the liver to plasma 125I ratio after injection of [125I]iodo-bGH by 50% was smaller (1.5 microgram/100 g BW) in T rats than in C animals (5 microgram/100 g BW). The rate of degradation of the labeled hormone, as far as could be assessed from the increasing solubility of 125I in 10% trichloroacetic acid, was slower in T than in C animals. Present findings indicate that the specific liver uptakes of bGH and oPRL are not affected in the same manner by severe hypothyroidism.

01 Jan 1974·Microvascular ResearchQ3 · MEDICINE

Fibrinolytic activity of an isolated equimolar human plasmin-streptokinase activator complex in an experimental dog model

Q3 · MEDICINE

Article

Author: Louis Summaria ; S.Frederick Rabiner ; Lila Friedman ; Kenneth C. Robbins

The isolated equimolar human plasmin-streptokinase activator complex was found to be an excellent fibrinolytic agent in an exptl. dog model.It dissolved artificially produced human clots placed in the femoral vein of the animals.The critical dose level of fibrinolytic activity was ∼0.1 mg/kg body weightAt the critical dose level, the activator complex was more effective than equivalent individual dose of either streptokinase or human plasmin.

100 Deals associated with Human Fibrinogen (Guangdong Shuanglin Biological Pharmaceutical)

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Afibrinogenemia	NDA/BLA	CN	Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.	08 Mar 2023
Deficiency Diseases	Phase 2	CN	Guangdong Shuanglin Biological Pharmaceutical Co. Ltd.	16 Aug 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis


No Data

Human Fibrinogen (Guangdong Shuanglin Biological Pharmaceutical)

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation