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Hemophilia A clinical trials

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NCT ID: NCT06357572 Completed - Hemophilia A Clinical Trials

Real-life Clinical FEIBA Samples Measured Using the Version A of the HemA EnzySystem

Start date: March 26, 2024
Phase:
Study type: Observational

The goal of this observational study is to assess if the version A of the HemA EnzySystem, a novel portable coagulation testing platform, can be used in patients with hemophilia A treated with Factor VIII Bypassing Agent (FEIBA). The main question[s] it aims to answer are: - Can the version A of the HemA EnzySystem can record thrombin generation within a time frame of 60 min in fresh whole blood samples of patients with hemophilia A treated with FEIBA? - Are the TGA results of the version A of the HemA EnzySystem in agreement with the TGA results obtained with conventional methods in fresh non frozen plasma? Participants are asked to fill in a questionnaire regarding their general health and hemophilia treatment. Subsequently, blood will be drawn from the patients before, and at 30, 120, and 240 minutes after FEIBA administration. Whole blood is immediately tested using the Version A HemA EnzySystem, and plasma is generated for testing with the Ceveron s100 (Technoclone). Leftover samples are frozen for later additional coagulation testing.

NCT ID: NCT06331091 Completed - Clinical trials for Hemophilia Arthropathy

Physiotherapy and Reaction Time in Hemophilia

Start date: December 10, 2022
Phase: N/A
Study type: Interventional

This randomised controlled study was conducted to investigate the comprehensive physiotherapy combined with home exercises on individuals with hemophilic arthropathy in the lower extremity. There are two groups in the study: home exercises and comprehensive physiotherapy combined with home exercises. Is physiotherapy combined with home exercises superior to home exercises on joint health, bleeding frequency, reaction time, dynamic balance, muscle strength? The aim of this study is to increase the compliance of hemophilic individuals to physiotherapy and adapt home exercises to their lives with weekly sessions.

NCT ID: NCT06281340 Completed - Hemophilia Clinical Trials

Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy

Start date: February 28, 2024
Phase: N/A
Study type: Interventional

Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations, intra-articular alterations, and chronic pain. Manual therapy techniques are used in the treatment of hemophilic ankle arthropathy for the improvement of pain and mobility. Design. Double-blind randomized pilot trial. Aimed: To evaluate the ultrasound changes by means of Doppler imaging after manual therapy intervention. Patients: A total of 20 adult patients with hemophilic ankle arthropathy will be recruited. Intervention: Each manual therapy session will last approximately 50 minutes, with 1 session per week for a period of 3 weeks. The treatment program includes 10 techniques that will be administered bilaterally. Measuring instruments: Patients will be evaluated qualitatively with ultrasound (HEAD-US scale) and assessment with Doppler ultrasound. The clinical variables will be joint damage (Hemophilia Joint Health Score) and pain intensity (Visual Analogue Scale). Expected results: Check the safety of manual therapy in patients with hemophilia regarding subclinical bleeding. Assess changes related to joint inflammatory state with imaging techniques. Observe changes in pain intensity and joint damage.

NCT ID: NCT06137092 Completed - Severe Hemophilia A Clinical Trials

rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study

Start date: July 22, 2023
Phase: Phase 3
Study type: Interventional

The study is designed as a randomized, two-armed, double-blind, single-dose, crossover, two-sequence, active-controlled, multi-center, bioequivalence clinical trial with a primary endpoint of dose-normalized area under the curve (dnAUC last)

NCT ID: NCT06020456 Completed - Clinical trials for Factor VIII Deficiency

Genetic Factors of the Desmopressin Response in Carriers of Hemophilia A

GIDEHAC
Start date: January 1, 2022
Phase:
Study type: Observational

Hemophilia A (HA) is a rare X-linked bleeding disorder caused by a deficiency in factor VIII (FVIII) affecting 1/5,000 males1. Carriers of HA are females carrying the pathogenic variant responsible for the familial HA at a heterozygous status. About 30% of HA carriers have low FVIII levels and can therefore have abnormal bleeding symptoms2,3. Such as males with moderate/mild HA, bleeding can be treated or prevented with either FVIII concentrates or desmopressin4,5. This drug acts as a vasopressin type 2-receptor (V2R) agonist that causes endothelial cells to rapidly secrete von Willebrand factor (VWF) and FVIII from Weibel-Palade bodies into the bloodstream6,7. However, the mechanism of action of post-DDAVP FVIII increase remains poorly understood in hemophilia A. One advantage of DDAVP is that it increases the level of endogenous FVIII, thus avoiding the need for potentially immunogenic exogenous FVIII. It is also cheaper than FVIII concentrates. Finally, it is more widely available in pharmacies in all hospitals with emergency rooms and surgical facilities. The FVIII response profile to DDAVP in carriers appears quite similar to that seen in men with mild/moderate HA8-11. A post-DDAVP increase in the FVIII level of 2-4 fold the basal level is usually observed. This FVIII response presents an important inter-individual variation making it necessary to carry out a therapeutic test before its use for the anti-hemorrhagic treatment. The basal FVIII level logically conditions the intensity of the post-DDAVP FVIII peak. However, other factors influencing the post-DDAVP FVIII response are very likely. Unfortunately, few series describing the FVIII response to DDAVP in HA carriers have been reported to date and they included too small numbers of patients to precisely analyze the factors of variation in the post-DDAVP FVIII pharmacokinetics (PK). Candy et al did not find any difference depending on the severity of the pathogenic variants for HA or on the age11. However, this study was carried out in a cohort including only 17 patients, therefore too small for a reliable statistical analysis. The GIDEHAC study (Genetic Influence of Desmopressin Efficacy in Hemophilia A Carriers) is a French study with the following objectives: the description of the post-DDAVP FVIII PK in a large retrospective cohort of HA carriers, the research of patients-related factors influencing this FVIII PK, and the building of predictive population- and Bayesian-based models.

NCT ID: NCT05804734 Completed - Hemophilia A Clinical Trials

Vitamin K Antagonist Versus Direct Oral Anticoagulant Treatments in Hemophilia

KADOAH
Start date: June 1, 2021
Phase:
Study type: Observational

Hemophilia is a rare X-linked bleeding disorder responsible for deficiency of coagulation factor VIII (FVIII) or IX (FIX). The main clinical manifestation is increased bleeding throughout the life which is directly correlated to the severity of the hemophilia, either mild (FVIII/FIX: 6-40), moderate (FVIII/FIX: 1-5%), or severe (FVIII/FIX<1%). Thanks to new therapies and long-term specialized follow-up by hemophilia treatment centers (HTCs), the life expectancy of patients with hemophilia (PWH) has improved considerably, even reaching that of the general population (1). Healthcare professionals are so more confronted to PWH with age-related pathologies, in particular cardiovascular pathologies such as atrial fibrillation, acute coronary syndromes or thromboembolic events (arterial or venous). It is now recommended in PWH that an anticoagulant treatment (AC) be prescribed as in the general population (2,3,4). The recently published COCHE study demonstrated a significantly increased risk of bleeding in PWH receiving antithrombotic treatment. This bleeding risk depended significantly on the type of antithrombotic treatment, which was higher for anticoagulant vs antiplatelet drugs, on basal levels of FVIII or FIX, and on the HAS-BLED score (5). Nowadays in the general population, among anticoagulant drugs, direct oral anticoagulants (DOACs) are preferred to vitamin K antagonist (KVA), thanks to their reduced risk of bleeding particularly intracerebral bleeding and better anticoagulant stability over time (6). However, we do not yet know precisely whether DOACs could occupy the same place in the PWH population because of the lack of evidence-based data due to the very small number of these patients, although some authors already recommend them over KVA. The KADOAH study was therefore set up to try to provide initial elements for future recommendations. Its main objective was to compare the level of bleeding risk of PWH treated with VKA vs DOACs.

NCT ID: NCT05752565 Completed - Hemophilia A Clinical Trials

Physical Activity and FVIII Elimination: Relevance to Personalized Therapy in Severe Hemophilia A

Start date: January 9, 2020
Phase: N/A
Study type: Interventional

In persons with severe haemophilia A infused factor VIII half-life and other pharmacokinetic can vary according to determinants such as blood group, von Willebrand factor (VWF) level or age. However, FVIII pharmacokinetics (PK) has not been throughly studied in patients with severe HA as a function of daily physical activity. It si known that vigorous intensity physical activity/exercise can transiently but significantly increase circulating levels of endogenous VWF and consequently FVIII in normal subjects and in patients with moderate or mild haemophilia A. The proposed study is a Proof of Concept one as it will be aimed at investigating the relation between daily physical activity, measured by Sensewear armband device, as number of daily steps and PK variability of infused rec-FVIII concentrate. This kind of investigation has never been done and it is a great interest also for the evaluation of patient's qualitiy of life.

NCT ID: NCT05728528 Completed - Hemophilia Clinical Trials

Impact of Moderate Intensity Physical Activities on PK-guided EHL FVIII Concentrates Prophylaxis Severe HA Patients

Start date: July 1, 2022
Phase: Phase 4
Study type: Interventional

To compare clinical outcomes before and after using combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis in moderate to severe hemophilia A patients

NCT ID: NCT05681845 Completed - Haemophilia A Clinical Trials

A Study to Compare the Blood Levels of Mim8 in Healthy Men When Administered With the DV3407-C1 Pen Injector or a Syringe and Cartridge

Start date: January 2, 2023
Phase: Phase 1
Study type: Interventional

Novo Nordisk is developing the study medicine Mim8 for the treatment of haemophilia A. The study aims to show similar levels of Mim8 in blood when using a new pen injector, called DV3407-C1 pen injector, and when using a syringe and cartridge. The new pen injector is intended to facilitate the administration of Mim8 for patients with haemophilia A. The participants will get Mim8 as injection under the skin (subcutaneously) of the belly using the DV3407-C1 pen injector and a needle (hereinafter referred to as pen injector) or using a needle and syringe from a cartridge (hereafter called syringe and cartridge). The participants will receive one injection with Mim8, either with the DV3407-C1 pen injector or with a syringe and cartridge. The study participation will last up to 20 weeks. Only healthy men can take part in the study.

NCT ID: NCT05651061 Completed - Clinical trials for Hemophilia A With Inhibitor

A Phase I of SS109 in Hemophilia A or and B With Inhibitors

Start date: December 14, 2022
Phase: Phase 1
Study type: Interventional

This phase I study aims to evaluate the safety, PK/PD and immunogenicity of SS109 in hemophilia A or and B with inhibitors. Twenty -seven patients are enrolled in study, and divided into five dose cohorts, from 30μg/kg to 360μg/kg. Dose 1 cohort enrolls three patients, each other dose cohorts enroll six patients. All patients included in the study will continue to be followed up until 28 days after SS109 administration.