[Translation] A multicenter, stratified, randomized, double-blind, placebo-controlled, phase III clinical trial of topical recombinant human thrombin for intraoperative hemostasis

试验目的：评价重组人凝血酶（CHO细胞）在肝脏切除术后毛细血管和小静脉渗血/小出血的辅助治疗及任何常规外科止血（如缝合、结扎或烧灼）无效或不适用时的止血疗效、止血安全性和免疫原性

[Translation]

Purpose: To evaluate the hemostatic efficacy, hemostatic safety and immunogenicity of recombinant human thrombin (CHO cells) in the adjuvant treatment of capillary and venous oozing/minor bleeding after liver resection and when any conventional surgical hemostasis (such as suturing, ligation or cauterization) is ineffective or not applicable

Start Date08 Nov 2019

Sponsor / Collaborator

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

CTR20171660 / CompletedPhase 1/2

外用重组人凝血酶用于肝段切除术中辅助止血的I/II期临床试验

[Translation] Phase I/II clinical trial of topical recombinant human thrombin for assisting hemostasis during liver segment resection

评价外用重组人凝血酶（rhThrombin）用于肝段切除术中毛细血管和小静脉渗血和出血辅助治疗的安全性、耐受性和免疫原性，初步探索有效性。

[Translation]

To evaluate the safety, tolerability, and immunogenicity of topical recombinant human thrombin (rhThrombin) for the adjuvant treatment of capillary and venous oozing and bleeding during liver segment resection, and to preliminarily explore its effectiveness.

Start Date29 Nov 2017

Sponsor / Collaborator

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

NCT00491608 / CompletedPhase 3

A Phase 3b, Open-Label, Single-Group Immunogenicity and Safety Study of Topical Recombinant Thrombin (rThrombin) in Surgical Hemostasis

The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.

Start Date01 Jun 2007

Sponsor / Collaborator

ZymoGenetics, Inc.

100 Clinical Results associated with Recombinant human thrombin (Zelgen Biopharma)

100 Translational Medicine associated with Recombinant human thrombin (Zelgen Biopharma)

100 Patents (Medical) associated with Recombinant human thrombin (Zelgen Biopharma)

Literatures (Medical) associated with Recombinant human thrombin (Zelgen Biopharma)

01 Feb 2024·Advanced Healthcare Materials

Thrombin and Thrombin‐Incorporated Biomaterials for Disease Treatments

Review

Author: Zhang, Qiong-Dan ; Wu, Fu-Gen ; Duan, Qiu-Yi ; Tu, Jing

AbstractThrombin, a coagulation‐inducing protease, has long been used in the hemostatic field. During the past decades, many other therapeutic uses of thrombin have been developed. For instance, burn treatment, pseudoaneurysm therapy, wound management, and tumor vascular infarction (or tumor vasculature blockade therapy) can all utilize the unique and powerful function of thrombin. Based on their therapeutic effects, many thrombin‐associated products have been certificated by the Food and Drug Administration, including bovine thrombin, human thrombin, recombinant thrombin, fibrin glue, etc. Besides, several thrombin‐based drugs are currently undergoing clinical trials. In this article, the therapeutic uses of thrombin (from the initial hemostasis to the latest cancer therapy), the commercially available drugs associated with thrombin, and the pros and cons of thrombin‐based therapeutics (e.g., adverse immune responses related to bovine thrombin, thromboinflammation, and vasculogenic “rebounds”) are summarized. Further, the current challenges and possible future research directions of thrombin‐incorporated biomaterials and therapies are discussed. It is hoped that this review may provide a valuable reference for researchers in this field and help them to design safer and more effective thrombin‐based drugs for fighting against various intractable diseases.

14 Nov 2023·Zhonghua yi xue za zhi

[Effect of recombinant human thrombin for hemostasis in liver resection: a randomized controlled phase Ⅲ clinical trial].

Article

Author: Luo, J ; Liu, J F ; Sun, K J ; Wu, J C ; Liu, J ; Du, C Y ; Du, L X ; Li, X H ; Yu, J ; Yan, S ; Liu, T Q ; Zheng, Q C ; Ni, Y ; Han, W Q ; Li, Q L ; Lun, Z J ; Fang, Z P ; Chen, G ; Wang, L C ; Qin, C J ; Gu, Y L ; Yi, W M ; Liu, Q ; Chen, Y J ; Lu, Z ; Tu, C Y

Objective: To evaluate the hemostatic efficacy, safety and immunogenicity of recombinant human thrombin in the treatment of liver wounds that still ooze after conventional surgical hemostasis. Methods: A multicenter, stratified randomized, double-blind, placebo-controlled phase Ⅲ trial with a planned enrollment of 510 subjects at 33 centers, with a 2∶1 randomization to the thrombin group versus the placebo group. An interim analysis will be conducted after approximately 70% of the subjects have completed the observation period. The primary efficacy endpoint was the rate of hemostasis within 6 minutes at the point of bleeding that could be evaluated. Safety analysis was performed one month after surgery, and the positive rates of anti-drug antibody (ADA) and neutralizing antibody were evaluated. Results: At the interim analysis, a total of 348 subjects had been randomized and received the study drug (215 were male and 133 were female). They were aged 19-69 (52.9±10.9)years. Among them, 232 were in the thrombin group and 116 were in the placebo group, with balanced and comparable demographics and baseline characteristics between the two groups. The hemostasis rate at 6 minutes was 71.6% (95%CI:65.75%-77.36%) in the thrombin group and 44.0% (95%CI: 34.93%-53.00%) in the placebo group, respectively (P<0.001). No grade≥3 drug-related adverse events and no drug-related deaths were reported from the study.No recombinant human thrombin-induced immunologically-enhanced ADA or immunologically-induced ADA was detected after topical use in subjects. Conclusion: Recombinant human thrombin has shown significant hemostatic efficacy and good safety in controlling bleeding during liver resection surgery, while also demonstrating low immunogenicity characteristics.

14 Sep 2021·Journal of Investigative SurgeryQ4 · MEDICINE

A Comparative Efficacy Evaluation of Recombinant Topical Thrombin (RECOTHROM^®) With A Gelatin Sponge Carrier Versus Topical Oxidized Regenerated Cellulose (TABOTAMP^®/SURGICEL^®) In A Porcine Liver Bleeding Model

Q4 · MEDICINE

Article

Author: Slezak, Paul ; Labahn, Dirk ; Keibl, Claudia ; Genyk, Yuri ; Gulle, Heinz ; Schmidbauer, Anna

PURPOSETopical hemostatic agents can be classified as active or passive. This study compared the hemostatic efficacy of an active agent, recombinant thrombin (RECOTHROM^® [rT]) plus gelatin sponge carrier versus a passive agent, oxidized regenerated cellulose (TABOTAMP^®/SURGICEL^® [ORC]), in a porcine liver abrasion model.MATERIALS AND METHODSEight pigs were used, four of them were heparinized. A total of 80 liver lesions were created, 40 of them in heparinized pigs. Lesions were treated with rT plus gelatin sponge or ORC. Bleeding rate was quantified before treatment by applying pre-weighed gauze. Time to hemostasis was assessed visually for 10 minutes.RESULTSSeven of the 80 lesions were excluded for having initial bleeding rates exceeding the target of 10 g/min. Sixteen and 20 lesions were treated with rT plus gelatin sponge and 19 and 18 lesions were treated with ORC, in non-heparinized and heparinized animals, respectively. Time to hemostasis (median [IQR]) was significantly shorter with rT plus gelatin sponge (30 [30,30] seconds) in heparinized and non-heparinized animals versus ORC in non-heparinized (180 [120,210] seconds) and heparinized animals (215 [135,345] seconds); P < 0.0001 for both comparisons. In heparinized animals, ORC took longer to achieve hemostasis, with treatment failure in 2/18 lesions. Time to hemostasis with ORC was longer for lesions in heparinized animals with initial bleeding rates of >5-10 g/min (285 [225,394] seconds) versus ≤5 g/min (175 [108,290] seconds).CONCLUSIONSIn this model, rT plus gelatin sponge carrier (active) was a more effective hemostat than ORC (passive) in both heparinized and non-heparinized animals.

100 Deals associated with Recombinant human thrombin (Zelgen Biopharma)

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Indication	Country/Location	Organization	Date
Hemorrhage	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	26 Dec 2023

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