Clinical Trials About "Chugai Pharma Emicizumab Receives Priority Review Designation Hemophilia" RSS

16:47 EST 16th December 2018 | BioPortfolio

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We have published hundreds of Chugai Pharma Emicizumab Receives Priority Review Designation Hemophilia news stories on BioPortfolio along with dozens of Chugai Pharma Emicizumab Receives Priority Review Designation Hemophilia Clinical Trials and PubMed Articles about Chugai Pharma Emicizumab Receives Priority Review Designation Hemophilia for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Chugai Pharma Emicizumab Receives Priority Review Designation Hemophilia Companies in our database. You can also find out about relevant Chugai Pharma Emicizumab Receives Priority Review Designation Hemophilia Drugs and Medications on this site too.

Showing "Chugai Pharma Emicizumab Receives Priority Review Designation Hemophilia" Clinical Trials 1–25 of 2,200+

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Efficacy, Safety, and Pharmacokinetic Study of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Participants

This randomized, multicenter, open-label, Phase 3 study is designed to investigate the efficacy, safety, and pharmacokinetics of emicizumab in participants with hemophilia A regardless of factor VIII (FVIII) inhibitor status. Participants who received episodic therapy with FVIII or bypassing agents prior to study entry and experienced at least 5 bleeds over the prior 24 weeks will be randomized in a 2:2:1 ratio to the following regimens: 1) Emicizumab prophylaxis at 3 milligram...

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Given Every 4 Weeks in Participants With Hemophilia A

This multicenter, open-label, non-randomized study will assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab administered at a dose of 6 milligrams per kilogram (mg/kg) every 4 weeks in participants with hemophilia A with or without inhibitors against factor VIII (FVIII). The study consists of 2 parts: a pharmacokinetic (PK) run-in part followed by an expansion part.

Study of Emicizumab Prophylaxis in Participants With Hemophilia A and Inhibitors Undergoing Minor Surgical Procedures

This Phase IV, multicenter study will evaluate whether participants with Hemophilia A and inhibitors receiving emicizumab prophylaxis can safely undergo minor surgical procedures without prophylactic bypassing agents (BPA).

A Study of Once-Weekly Emicizumab in Children and Adolescents With Hemophilia A and Factor VIII (FVIII) Inhibitors

This single-arm study will enroll children (less than [

A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors

This is a phase IIIb, single arm, open-label, multi-center study to evaluate the safety and tolerability of emicizumab in participants with congenital hemophilia A who have documented inhibitors against Factor VIII (FVIII) at enrollment. Approximately 200 participants, aged 12 or older, will be enrolled in this study and are expected to be enrolled at approximately 85 sites globally. Participants will receive an initial weekly dose of prophylactic emicizumab subcutaneously for ...

A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors

This is a randomized, multicenter, open-label, Phase 3 clinical study in participants aged 12 years or older to evaluate the efficacy, safety, and pharmacokinetics of prophylactic emicizumab versus no prophylaxis in participants with severe hemophilia A without inhibitors against FVIII.


Understanding Hemophilia A and B Drug Dosage Administration Patterns

Study Design A prospective observational, cross-sectional epidemiological study in U.S. site-based clinical practice settings. 30 sites will enroll approximately 300 patients Participating patients - or their caregiver in the case of patients under the age of 18 - will be consented to participate. Physicians complete a retrospective chart review on each enrolled patient. Patients will complete a one-time study questionnaire.

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers

This single-center, open-label study will evaluate the pharmacokinetics, safety, and tolerability of emicizumab following a single subcutaneous (SC) administration to healthy Chinese subjects.

ATHN 7: Hemophilia Natural History Study

This is a real-world study of the safety of the treatments used for people with hemophilia. The study will follow people with hemophilia A or B from across the country for about 4 years as they receive treatment. The hemophilia treatment center (HTC) physician and participant will decide on the FDA-approved treatment to be used which may include non-factor products, bypassing agents, or clotting factor replacement products. The goal of this research is to study the use of hemop...

Study Evaluating ReFacto in Hemophilia A

To identify the causative mutations in previously untreated patients with hemophilia A enrolled in the ReFacto® clinical safety and efficacy study CTN 93-R833-0XX/C9741-28, using two established hemophilia mutation testing laboratories (one in Europe and one in North America).

Females With Severe or Moderate Hemophilia A or B: A Multi-Center Study

To collect and analyze data on females with hemophilia so as to better define the difference between the study population and the male population with hemophilia.

Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A

The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity, and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to severe hemophilia A.

Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia

To correlate the HLA type and genetic defect with hemophilia A.

Epidemiology and Immunology of Hemophilia A Inhibitors

To determine the risk factors associated with inhibitor formation in hemophilia A and to study the mechanism of tolerance in the murine hemophilia A model.

Health Practice of Hemophilia Patiente Care During Pregnancy, Delivery and Newborn Children

Prenancy and specialy delivery for hemophilia mother and her children possibly hemophilia is risked. Diagnostical of hemophilia pregnan is the first difficulty but patients with hemorrhagic menstruation without etiology known, hemorrhagic complication during a chirurgical procedure or during previously pregnancy currently are examine in Haemostasis consultation. None French recommendation specifie for health practice of these hemophilia patients exists. However, Anglo-S...

Bleeding Symptoms of Carriers of Hemophilia A and B

To collect and analyze data on female carriers of severe and moderate hemophilia A and B.

Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

To assess efficacy and safety of BeneFix® for prophylaxis in "Short-term" therapy and on demand therapy for all bleeding episodes of subjects with hemophilia B.

Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study

This is a multi-center, international study designed to collect clinical, genetic and quality of life information on females with hemophilia, an inherited bleeding disorder. The study is designed to determine whether there are problems and issues unique to females with hemophilia.

Gene Modified autoHST for Type A or B Hemophilia

This study is a Phase I/II trial using a novel bioengineered lenti viral vector to deliver a normal gene for human clotting factor VIII or factor IX into patients with hemophilia A or hemophilia B, to evaluate the safety, efficacy and pharmacokinetics of IV infusion of gene modified autoHST in patients.

GOLD-B: A Gene Therapy Study for Hemophilia B

A Phase 1/2, Open-Label, Non-Randomized, Dose-Escalation Study of SPK-9001 in Subjects with Hemophilia B.

Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A

The purpose of this study is to obtain additional data on the safety and efficacy of Wilate in PTPs with hemophilia A with at least 150 previous exposure days (EDs) to a FVIII concentrate who undergo prophylactic treatment with Wilate for 6 months and at least 50 EDs, thus supplementing the existing database to obtain approval of Wilate for the indication hemophilia A in the USA.

World Bleeding Disorders Registry

The WBDR is an international observational disease registry of patients with hemophilia. It will provide a platform for a network of hemophilia treatment centres (HTCs) around the world to collect uniform and standardized patient data and guide clinical practice. With informed consent from the patient, the WBDR stores anonymous data about the person's disease, such as hemophilia type and severity, symptoms, and treatment.

GAS-Hem Feasibility Study

The purpose of this study is to investigate the feasibility and acceptability of the Standardized Goal Attainment Scaling menu for Hemophilia (GAS-Hem) as a patient reported outcome (PRO) measure to monitor clinical progress in participant-identified goal areas in individuals with hemophilia A.

Weight-based Dosing in Hemophilia A

Hemophilia A is an inherited (genetic) disease where a protein, factor VIII (FVIII), which promotes blood clotting is missing or does not work properly. Individuals with hemophilia A are at risk for bleeding. Bleeding is prevented and/or treated with recombinant factor VIII (rFVIII), which is an FDA-approved treatment for Hemophilia A. Obesity is common among patients with hemophilia. Some studies have shown that obese hemophilia patients may be able to prevent bleeding with a ...

A Study of the Impact of Hemophilia and Its Treatment on Brain Development, Thinking and Behaviour in Children With Hemophilia

The Hemophilia Growth and Development Study (HGDS) nearly 25 years ago showed haemophilia and HIV impacted brain development, thinking, and behaviour in children and adolescents. The eTHINK study is designed to understand whether advances in hemophilia treatment have removed any impact of hemophilia. If there still is an impact of hemophilia, the eTHINK study will help to identify which children or adolescents are still at risk, and how to screen other children. Participants an...

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