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Thrombocytopenia clinical trials

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NCT ID: NCT05393999 Withdrawn - Lymphoma Clinical Trials

SABRE: A Single-arm Prospective Study Measuring Safety and Tolerability of SARS-CoV-2 Neutralising Antibodies in High-risk Populations

SABRE
Start date: November 29, 2021
Phase: Phase 2
Study type: Interventional

The SABRE study is a single-arm prospective study measuring safety, tolerability and pharmacokinetics of two SARS-CoV-2 neutralising antibodies (BMS-986414 and BMS-986413) amongst high-risk special populations of vaccine non-responders. The aim is to test the hypothesis that for individuals who fail to mount a measurable immune response to a routinely offered SARS-CoV-2 prophylactic vaccine or for those who are not able to receive such a vaccine (for example those receiving a bone marrow transplant or starting chemotherapy treatment), the receipt of subcutaneous injection of two long-acting neutralising antibodies BMS-986414 and BMS-986413 will confer durable high titres and subsequent immunological protection against SARS-CoV-2 infection.120 eligible participants will be enrolled and followed up for 48 weeks after the one-time dosing visit. Primary inclusion criteria are patients age 18 years and older and either 1) have received two doses of a routine NHS standard of care SARS-Cov-2 vaccine and do not have detectable serum SARS-CoV-2 anti-spike antibodies in routine NHS assays more than two weeks post-vaccination, or do not have protective levels of antibody or 2) be ineligible to receive a SARS-CoV-2 prophylactic vaccine. This could be because they need to commence immediate systemic chemotherapy or receive bone marrow and therefore the requirement to initiate profound immune suppression. Primary objectives are to determine the safety, tolerability and detectable SARS-CoV-2 antibody by specific PPD assay in serum at 12 weeks after enrolment.

NCT ID: NCT05261646 Withdrawn - Clinical trials for Chemotherapy-Induced Thrombocytopenia

A Clinical Study of Hetrombopag Olamine Tablets in Adults Receiving 21-day Cycles of Chemotherapy for Solid Tumours, Who Are Delayed for at Least 1 Week From Their Scheduled Cycle Because of Chemotherapy-induced Thrombocytopenia

Start date: April 15, 2022
Phase: Phase 3
Study type: Interventional

The study is aimed to evaluate the efficacy of different doses of hetrombopag compared to placebo, measured by the proportion of subjects that can complete two planned consecutive chemotherapy cycles with no modification of chemotherapy regimen (i.e., delayed start, dose reduction, omission, or discontinuation) because of thrombocytopenia [platelet count <100×109/L], to determine an optimal dose of hetrombopag and to demonstrate its superiority over placebo.

NCT ID: NCT05046327 Withdrawn - Clinical trials for Immune Thrombocytopenia

Open-Label Study to Evaluate the Safety and Efficacy of Avatrombopag and Remission Rates in Adults With ITP of ≤6 Months

Start date: October 14, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of avatrombopag in subjects with a confirmed diagnosis of primary ITP (≤6 months duration) over 26 weeks of treatment, and also evaluate the incidence of ITP remission.

NCT ID: NCT05040776 Withdrawn - Covid19 Clinical Trials

COVID-19 ThromboprophylaXIs Study of Novel FXIa Inhibitor Frunexian (EP-7041) in ICU Patients

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

This is a multicenter, open-label, single cohort study of patients with confirmed COVID-19 syndrome who based on clinical judgment require care in an intensive care unit, regardless of whether or not mechanical ventilation is in use or is anticipated. Patients should be enrolled on the first day of the ICU stay; withdrawal of prior thromboprophylaxis, if any, will follow specific protocol guidance. Enrolled patients will thereafter be administered intravenous frunexian (EP-7041) until disposition from the hospital (including post-ICU non-critical care management)

NCT ID: NCT04933942 Withdrawn - Clinical trials for First Progression of MGMT Promoter-methylated Glioblastoma

Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma

RIGOLETTO
Start date: September 13, 2022
Phase: Phase 2
Study type: Interventional

Romiplostim for low platelets caused by lomustine chemotherapy in patients with first recurrence (growing back) of a brain tumor, glioblastoma that is MGMT methylated. Lomustine is an anticancer drug often used to treat glioblastoma that grows back after initial treatment. This anticancer drug can cause side effects. The most frequent and potentially serious side effect of all is lowering of the blood platelets. Low platelets can cause bleedings in the the stomach and intestines, the skin, the brain and other systems and tissues. Low platelets are also the main cause of delaying or prematurely (ending treatment before the planned end) stopping chemotherapy. There is no treatment for low platelets except platelet transfusions. Romiplostim is a drug that stimulates the production of platelets in the bone marrow. It is an approved drug in USA, Europe, Australia and Switzerland for a special type of blood disease in which the body breaks down its own blood platelets. The purpose of the study is to start the treatment with romiplostim once low platelets are diagnosed in order to restore the platelet count and to prevent the platelet count from dropping again during the lomustine treatment.

NCT ID: NCT04437953 Withdrawn - Cancer Clinical Trials

Avatrombopag for Thrombocytopenia in People With Cancer

Start date: May 27, 2020
Phase: Phase 2
Study type: Interventional

This study will test whether avatrombopag is an effective treatment for thrombocytopenia in people who have both cancer and a liver disease (such as cirrhosis, cholangitis, or hepatitis). Researchers will look at whether giving participants avatrombopag for 3 weeks can raise their platelet levels enough for them to begin chemotherapy. The study will also test whether avatrombopag can continue to be effective against thrombocytopenia while participants are on chemotherapy for 12 weeks or longer. In addition, researchers will determine how safe the study drug is in participants.

NCT ID: NCT04312789 Withdrawn - Platelet Disorder Clinical Trials

Avatrombopag for the Treatment of Thrombocytopenia After Donor Hematopoietic Stem Cell Transplant

Start date: December 2022
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects and how well avatrombopag works for the treatment of thrombocytopenia after donor hematopoietic stem cell transplant. Thrombocytopenia is defined as abnormally low level of platelets in the blood. Avatrombopag is a small molecule thrombopoietin receptor agonist which stimulates thrombopoietin receptor leading to increase production of platelets.

NCT ID: NCT04274452 Withdrawn - Clinical trials for Primary Immune Thrombocytopenia (ITP)

A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP)

ADVANCE2
Start date: June 29, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in patients with primary ITP.

NCT ID: NCT04039477 Withdrawn - Clinical trials for Immune Thrombocytopenia

A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP

MARINA
Start date: July 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2 randomized, dose-blind, multicenter study designed to evaluate the safety, tolerability, efficacy, Pharmacokinetics (PK), and Pharmacodynamics (PD) of treatment with KZR-616 in patients with active Autoimmune Hemolytic Anemia or Immune Thrombocytopenia.

NCT ID: NCT03968484 Withdrawn - Sepsis Clinical Trials

Platelet Transfusion in Sepsis Trial

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

Platelets are important mediators of an inflammatory response and a key component of the innate immune system to defend the human body against invading pathogens. However, little evidence exists regarding the number of platelets that should be used als transfusion threshold in septic patients. In this trial platelet transfusion will be performed with either <50000/µl or <20000/µl as a trigger.