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Thrombotic Microangiopathies clinical trials

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NCT ID: NCT05702996 Not yet recruiting - Clinical trials for Thrombotic Microangiopathies

Multicenter, Uncontrolled Pilot Study Evaluating the Efficacy of Eculizumab in the Treatment of Gemcitabine-induced Thrombotic Microangiopathies

GEMECULI
Start date: March 2023
Phase: Phase 3
Study type: Interventional

The main objective of this prospective multisite trial is to study the evolution of TMA (thrombotic microangiopathy) induced by gemcitabin and treated by eculizumab.

NCT ID: NCT05634928 Recruiting - Clinical trials for Thrombotic Microangiopathies

Construction of a Database for TMA

Start date: December 1, 2022
Phase:
Study type: Observational [Patient Registry]

Information about patients was collected by reviewing the Hitech case system and telephone and outpatient follow-up, and the case database was constructed by Epidata software. The sample size is expected to be 200 cases, the participating hospital is the First Affiliated Hospital of Soochow University, and the study time frame is from Dec 1, 2022, to Nov 31, 2027. The observation indexes of the study include the basic information of patients' age and gender and the clinical-related data of thrombotic microangiopathy.

NCT ID: NCT05504187 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus

Start date: October 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of KP104 in participants with systemic lupus erythematosus (SLE)-Thrombotic microangiopathy (TMA). The study consists of 2 parts: Part 1 (Dose Optimization) and Part 2 (Proof of Concept). All participants will receive KP104 in combination with standard of care (SOC) for SLE-TMA.

NCT ID: NCT05148299 Recruiting - Clinical trials for Transplant-Associated Thrombotic Microangiopathy

Evaluate the PK Efficacy Safety and Tolerability of Pegcetacoplan in Patients With Thrombotic Microangiopathy

Start date: February 1, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the study is to assess PK, Pharmacodynamics (PD), Efficacy and safety of pegcetacoplan in patients with TA-TMA after HSCT.

NCT ID: NCT04970004 Withdrawn - Clinical trials for Stem Cell Transplant Complications

Study in Adult and Pediatric Patients With HSCT-TMA

Start date: July 12, 2021
Phase:
Study type: Observational

This is an observational, retrospective study designed to assess outcomes in patients diagnosed with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who were not treated with complement component (C5) inhibitor therapy. Data required to evaluate study outcomes will be abstracted from the medical records of all patients who meet study eligibility criteria.

NCT ID: NCT04949698 Not yet recruiting - Clinical trials for Pregnancy-related Thrombotic Microangiopathies

Risk Factors and the Effect of Plasma Exchange on Prognosis of Pregnancy-related Thrombotic Microangiopathies

Start date: August 1, 2021
Phase:
Study type: Observational

Early identification of the risk factors of pregnancy-related thrombotic microangiopathies can help us reduce the complications of such patients and increase the survival rate of patients. In addition, it is still controversial whether patients with pregnancy-related thrombotic microvessels should receive plasma therapy.

NCT ID: NCT04845022 Recruiting - Clinical trials for THROMBOTIC MICROANGIOPATHY

Incidence of Snakebite Associated Thrombotic Microangiopathy & Role of Peripheral Blood Smear as a Predictor of Clinical Outcome

Start date: January 28, 2021
Phase:
Study type: Observational

The aim of this study is to find the overall incidence of thrombotic microangiopathy in snakebite victims. As we know snakebite is a common in tropical regions. Many a times the early diagnosis of TMA is missed and precious time which could have helped in improving the patient prognosis is lost. Also via this study we wish to learn the role of cost effective test like peripheral smear which could help learn morphological picture of red blood cells and thus help in early prediction of patients clinical prognosis.

NCT ID: NCT04784455 Recruiting - Clinical trials for Thrombotic Microangiopathies

Nomacopan (rVA576) in Transplant Associated Thrombotic Microangiopathy

Start date: February 1, 2021
Phase: Phase 3
Study type: Interventional

Multicentre Study of nomacopan in Paediatric Haematopoietic Stem-Cell Transplant Associated Thrombotic Microangiopathy

NCT ID: NCT04777435 Recruiting - Clinical trials for Thrombotic Micro-angiopathy

Therapeutic Orientation Test in Thrombotic Microangiopathy

TOTEM
Start date: April 3, 2021
Phase: N/A
Study type: Interventional

Haemolytic and Uraemic Syndrome (HUS) is a serious disease requiring rapid diagnosis and management. The atypical HUS diagnosis has been greatly improved by anti-CS antibody (Eculizumab) wich block alternative complement pathway activation. To rise treatment success, Eculizumab introduction should be as early as possible. In some secondary HUS (infection, drugsā€¦) complement is also involved as "second-hit". To date, there is no tool to confirm complement involvement in a HUS at diagnosis stage. This study suggest to evaluate a therapeutic orientation test, in order to determine the complement implication in HUS diagnosis. The test evaluates the complement deposits on endothelial cell surface in vitro, compared to a normal human serum. In order to determine the test performance, first the positive or negative results will be compared to the HUS clinical evolution, treated or not by the clinician with Eculizumab. Second, the test results will be compared to the presence of alternative complement pathway regulation abnormalities.

NCT ID: NCT04745195 Recruiting - Clinical trials for Thrombotic Microangiopathies

Complement Prospective Evaluation of Thrombotic Microangiopathy on Endothelium

COMPETE
Start date: August 12, 2021
Phase:
Study type: Observational [Patient Registry]

Thrombotic microangiopathy (TMA) is a severe and life-threatening condition, often affecting the kidneys and brain. It can occur on the background of various clinical conditions. Dysregulation of the alternative pathway of complement may be the etiological factor and this type of TMA is classified, according to the current nomenclature, as primary atypical hemolytic uremic syndrome (HUS). Half the patients with primary atypical HUS present with rare variants in complement genes, although coexisting conditions are often needed for the TMA to become manifest. In patients with secondary atypical HUS, certain coexisting conditions appear to drive the disease and treatment should target the underlying condition to remit the TMA. Recently, the investigators demonstrated, by using a novel in-house developed functional endothelial cell-based test, that complement dysregulation and overactivation is the dominant cause of disease and its sequelae in a subset of patients with secondary atypical HUS, having impact on treatment and prognosis. The investigators did first prove this concept in patients presenting with TMA and hypertensive emergency. A prospective study is needed to further corroborate these findings along the spectrum of TMA. The investigators hypothesize that their functional endothelial cell-based test, the so-called "HMEC" test, can better categorizes the TMA into different groups with potential therapeutic and prognostic implications. Thus, paving the road to the ultimate goal of precision medicine.