Last update 01 Nov 2024

Vitamin K Deficiency Bleeding

Last update 01 Nov 2024

Basic Info

Synonyms

Vitamin K Deficiency Bleeding, ビタミンK欠乏性出血症, ビタミンK欠乏性出血症-新生児

+ [8]

Introduction

Hemorrhage caused by vitamin K deficiency.

Drugs associated with Vitamin K Deficiency Bleeding

Menatetrenone

Target-

Mechanism

Osteogenesis stimulants

Active Org.

Alfresa Pharma Corp. [+3]

Originator Org.-

Active Indication

Vitamin K Deficiency Bleeding [+4]

Inactive Indication

Hepatocellular Carcinoma [+1]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date29 Jun 1972

Phytonadione

Target-

Mechanism-

Active Org.

Institute of Oncology Ljubljana [+8]

Originator Org.

Bausch Health Americas, Inc.

Active Indication

Vitamin K Deficiency [+4]

Inactive Indication

Hypoprothrombinemias

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date30 Sep 1955

Menadione

Target-

Mechanism-

Active Org.-

Originator Org.

Eli Lilly & Co.

Active Indication-

Inactive Indication

Exanthema [+1]

Drug Highest PhaseWithdrawn

First Approval Ctry. / Loc.-

First Approval Date20 Jan 1800

Clinical Trials associated with Vitamin K Deficiency Bleeding

CTR20242953 / RecruitingNot Applicable

评估受试制剂维生素K1片（规格：5 mg）与参比制剂维生素K1片（规格：5 mg）在健康成年参与者餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test vitamin K1 tablets (strength: 5 mg) and the reference vitamin K1 tablets (strength: 5 mg) in healthy adult participants in the postprandial state.

主要试验目的：研究餐后状态下单次口服受试制剂维生素K1片（规格：5 mg，江苏宣泰药业有限公司生产）与参比制剂维生素K1片（规格：5 mg；Cadila Healthcare Limited生产）在健康参与者体内的药代动力学特征，评价餐后状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂维生素K1片（规格：5 mg）和参比制剂维生素K1片（规格：5 mg）在健康参与者中的安全性。

[Translation]

Main purpose of the study: To study the pharmacokinetic characteristics of the test vitamin K1 tablet (specification: 5 mg, produced by Jiangsu Xuantai Pharmaceutical Co., Ltd.) and the reference vitamin K1 tablet (specification: 5 mg; produced by Cadila Healthcare Limited) in healthy participants after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary purpose of the study: To study the safety of the test vitamin K1 tablet (specification: 5 mg) and the reference vitamin K1 tablet (specification: 5 mg) in healthy participants.

Start Date04 Sep 2024

Sponsor / Collaborator

Sinotherapeutics, Inc.

CTR20242175 / RecruitingNot Applicable

维生素K1注射液在口服给药条件下的人体生物等效性试验和药效学研究

[Translation] Bioequivalence test and pharmacodynamics study of vitamin K1 injection in humans under oral administration conditions

本研究考察健康受试者在空腹及餐后条件下，单次口服由成都苑东生物制药股份有限公司提供的维生素K1注射液（受试制剂，规格：1mL:10mg）与相同条件下单次口服由Cheplapharm Arzneimittel GmbH持证的维生素K1注射液（参比制剂，商品名：Konakion® MM，规格：1mL:10mg）的药动学特征，评价在口服给药条件下两制剂间的生物等效性及安全性，并探索口服给药条件下受试者INR变化和维生素K1在人体的PK/PD关系，为该受试制剂的注册申请提供依据。

[Translation]

This study investigated the pharmacokinetic characteristics of a single oral administration of vitamin K1 injection (test preparation, specifications: 1mL:10mg) provided by Chengdu Yuandong Biopharmaceutical Co., Ltd. and a single oral administration of vitamin K1 injection (reference preparation, trade name: Konakion® MM, specifications: 1mL:10mg) certified by Cheplapharm Arzneimittel GmbH under the same conditions in healthy subjects under fasting and postprandial conditions, evaluated the bioequivalence and safety of the two preparations under oral administration conditions, and explored the relationship between the changes in INR of subjects under oral administration conditions and the PK/PD of vitamin K1 in humans, providing a basis for the registration application of the test preparation.

Start Date05 Jul 2024

Sponsor / Collaborator

Chengdu Easton Biopharmaceuticals Co., Ltd.

CTR20241741 / CompletedNot Applicable

维生素K1注射液人体生物等效性研究

[Translation] Study on bioequivalence of vitamin K1 injection in human body

本试验旨在研究健康受试者空腹状态下单次静脉注射石家庄四药有限公司研制、生产的维生素K1注射液（1 ml:10 mg）的药代动力学特征；以Cheplapharm Arzneimittel GmbH生产的维生素K1注射液（Konakion MM，1 ml:10 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性，并观察两制剂在健康受试者中的安全性。

[Translation]

This study aimed to study the pharmacokinetic characteristics of a single intravenous injection of vitamin K1 injection (1 ml:10 mg) developed and produced by Shijiazhuang Siyao Co., Ltd. in healthy subjects under fasting state; using vitamin K1 injection (Konakion MM, 1 ml:10 mg) produced by Cheplapharm Arzneimittel GmbH as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, the human bioequivalence of the two preparations was evaluated, and the safety of the two preparations in healthy subjects was observed.

Start Date03 Jul 2024

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

100 Clinical Results associated with Vitamin K Deficiency Bleeding

100 Translational Medicine associated with Vitamin K Deficiency Bleeding

0 Patents (Medical) associated with Vitamin K Deficiency Bleeding

287

Literatures (Medical) associated with Vitamin K Deficiency Bleeding

01 Aug 2024·BMJ Case Reports

Late-onset vitamin K deficiency presenting as haemorrhagic shock and severe multi-system organ failure

Article

Author: Azar, Justin M ; Thomas, Tessy A ; Maffei, Frank Anthony ; Lambert, Richard

Vitamin K is an essential dietary cofactor required for the synthesis of active forms of vitamin K-dependent procoagulant proteins. Vitamin K deficiency, particularly late-onset deficiency occurring between 1 week and 6 months of age, can cause a life-threatening bleeding disorder. An exclusively breastfed, full-term, 6-week-old infant male presented with severe haemorrhagic shock and multi-system organ failure related to caregiver refusal of intramuscular vitamin K after birth. Coagulation studies were normalised within 8 hours of intramuscular vitamin K administration. An increasing number of caregivers are refusing intramuscular vitamin K which has led to a rise in the incidence of vitamin K deficiency bleeding. Health policy organisations around the world emphasise the benefits of intramuscular vitamin K and risks of refusal, particularly in exclusively breastfed infants who are at higher risk due to low vitamin K levels in breast milk. This case highlights the multi-system severity of this life-threatening yet preventable disorder.

08 Jul 2024·Cureus

A Case of Vitamin K Deficiency Bleeding in a Newborn: Catastrophic Yet Preventable

Article

Author: Klawinski, Darren ; Klawinski, Amanda ; Shah, Chetan ; Nakagawa, Thomas ; Nmadu, Yeka W ; Bernhard, Joseph

A four-week-old full-term male infant presented to the emergency department with blood in the diaper, increasing lethargy, and vomiting and was found to have multiple intracranial hemorrhages on CT. He was delivered at home and did not receive vitamin K. Coagulation studies were abnormal, and des-gamma carboxyprothrombin (DCP) was 481, diagnostic of vitamin K deficiency. He received vitamin K and required multiple antiepileptic medications for seizure control. Vitamin K deficiency bleeding (VKDB) is a preventable disease that can have devastating consequences and could present as early, classical, or late-onset. The typical presentation manifests with cutaneous, gastrointestinal, or intracranial hemorrhage most commonly in fully breastfed infants. Vitamin K prophylaxis has proven to be effective. With increasing out-of-hospital delivery and online misinformation, there is a declining administration of intramuscular vitamin K at birth. It is the responsibility of healthcare providers to properly inform patients and their families of the importance of vitamin K prophylaxis at or before the time of delivery.

01 Jun 2024·Indian Journal of Pediatrics

Late Onset Vitamin K Deficiency Bleeding in a Neonate and Role of Elevated PIVKA-II Levels

Letter

Author: Kumar, Chanchal ; Pothala, Rajeev ; Marda, Srikanth ; Deshmukh, Namita

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