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NCT ID: NCT05439941 Terminated - Atopic Dermatitis Clinical Trials

A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials

Start date: June 6, 2022
Phase: Phase 2
Study type: Interventional

This is an Open-Label Extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of EDP1815 in participants with mild, moderate, and severe atopic dermatitis who have completed the treatment period of a prior clinical study ("parent study") with EDP1815. The current parent study of this protocol is the EDP1815-207 study; A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Cohort Study Investigating the Effect of EDP1815 in Participants for the Treatment of Mild, Moderate and Severe Atopic Dermatitis.

NCT ID: NCT05438498 Terminated - Clinical trials for SARS-CoV-2 Infection

Real World Evaluation of the Effectiveness of AZD7442 for Prevention of SARS-CoV-2

Start date: June 3, 2022
Phase: Phase 3
Study type: Interventional

If a treated cancer patient cannot make antibodies to a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Emergency Use Authorization (EUA) or approved vaccine, their risk for infection and its sequelae are significantly increased. The Astra-Zeneca Immuno-Suppressed Program (AISP) is designed to address whether a patient treated for cancer who receives a single-dose of Evusheld (AZD7442) 600 mg IM or IV will maintain a stable/protective effect against symptomatic SARS-CoV-2 infection including SARS-CoV-2 related hospitalization and/or SARS-CoV-2 related death up to 12 months post-baseline. The program will focus on patients with cancer who have been treated with chemotherapy, immunotherapy, targeted therapy, other therapy or combination therapy with or without radiation therapy within 12 months prior to enrollment, are willing/able to receive one IM or IV injection of Evusheld, are able to complete 14 Patient Experience/Clinical Outcome Assessment (COA) surveys, 6 Quality of Life (QoL) assessments and are willing to allow serum concentrations of Evusheld to be drawn 9 times, 3 SARS-CoV-2 Receptor Binding Domain-Immunoglobulin G (RBD-IgG) tests, and T-cell assay to be drawn once. In the event of a symptomatic break-thru SARS-CoV-2 positive infection by SARS-COV-2 Ribonucleic Acid (RNA) by Reverse Transcription Polymerase Chain Reaction (RT-PCR) test, the patient will have an additional Evusheld serum concentration, SARS-CoV-2 RBD-IgG antibody level and T-cell assay obtained in a temporally related manner. The program requires treatment with Evusheld 600 mg IM or IV.

NCT ID: NCT05438485 Terminated - Propionic Acidemia Clinical Trials

Natural History Study of Patients With Methylmalonic Acidemia and Propionic Acidemia

JUMP
Start date: August 27, 2021
Phase:
Study type: Observational [Patient Registry]

The JUMP (Journey to Understand MMA and PA) Study is being conducted by HemoShear Therapeutics and AllStripes, a rare disease online research platform. JUMP is designed to accelerate understanding of the natural course of methylmalonic acidemia (MMA) and propionic acidemia (PA) disease and treatment for families, researchers, clinicians and industry. The study will collect and provide patient medical record information from multiple institutions for families to access in one place at no cost. AllStripes will remove identifying information like name and address from these medical records and aggregate this data for the HemoShear team to better understand the medical experience and progression of MMA and PA over time. In addition, academic researchers, healthcare practitioners and patient advocacy groups can apply to use the collective patient community data to answer specific research questions at no cost. HemoShear is collecting natural history data on MMA and PA because the company needs insight into the real-world experience of many patients to better understand the disease and be able to scientifically demonstrate whether the potential new treatment they are developing is effective in improving outcomes. This natural history study will include retrospective and prospective components. The retrospective component will consist of data abstracted from primarily electronic health records (eHR) and some paper records. The prospective component will include ongoing collection of medical records from enrolled participants, and participants may opt in to complete health-related questionnaires and an optional genetic testing sub-study. After signing informed consent, participants or their legal guardians will grant permission to AllStripes to collect their health records for data abstraction. Participants may opt into an optional no cost genetic testing sub-study. The JUMP (Journey to Understand MMA and PA) sub-study will help assess whether the genetic variant of the affected person may relate to disease severity and treatment response. Getting genetic testing will enable participants to understand the genetic mutation that causes their type of methylmalonic acidemia (MMA) or propionic acidemia (PA). Knowing the genetic mutations (whether from the MMUT, MMAA or MMAB gene or PCCA or PCCB) can help the impacted person, their caregivers and healthcare professionals understand the potential course of disease and select approaches to better manage the disease. The additional information will enable HemoShear and AllStripes to understand whether different genetic variants impact the disease journey and outcomes. A separate informed consent will be obtained for participating in the sub-study.

NCT ID: NCT05437679 Terminated - Prostate Cancer Clinical Trials

Characterization of Circulating Tumor Cells (CTCs) in High Risk and Early Metastatic Prostate Cancer Patients Using Parsortix® System

CHARTER
Start date: July 5, 2022
Phase:
Study type: Observational

This study is designed to evaluate the presence and numbers of circulating tumor cells (CTCs) and cancer related gene expression levels in subjects with localized high-risk prostate cancer (HRLPC) and from subjects with non-metastatic disease experiencing biochemical recurrence and castration-resistance (BCRLPC and NMCRPC groups, respectively) who are about to undergo next generation imaging (NGI, such as Axumin® or PSMA PETCT). The investigators will also evaluate subjects with localized indolent prostate cancer who are on active surveillance (AS) as a control population. The CTC and gene expression results will be evaluated for association with disease state and progression and survival.

NCT ID: NCT05435846 Terminated - Clinical trials for Metastatic Lung Non-Small Cell Carcinoma

Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell Lung Cancer With MET Exon 14 Skipping Mutation

Start date: August 10, 2022
Phase: Phase 1
Study type: Interventional

This phase I/Ib trial studies the side effects and best doses of capmatinib plus trametinib when given together for the treatment of patients with MET exon 14 skipping mutation non-small cell lung cancer that has spread to other places in the body (metastatic). Capmatinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Trametinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Capmatinib and trametinib are "targeted therapies." These targeted therapies work by detecting and targeting a mutation in the MET gene. Giving Capmatinib and trametinib may kill more tumor cells in patients with metastatic non-small cell lung cancer.

NCT ID: NCT05435339 Terminated - Solid Tumor, Adult Clinical Trials

A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy

Start date: October 4, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The drug that will be investigated in the study is GEN1053. GEN1053 is an antibody designed to (re)activate and increase antitumor immunity. Since this is the first study of GEN1053 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN1053 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1053. GEN1053 will be studied in a broad group of cancer patients, having different kinds of solid tumors. All participants will get GEN1053. The study consists of two parts: Part 1 tests increasing doses of GEN1053 ("escalation"), followed by Part 2 which tests the recommended phase 2 dose GEN1053 dose from Part 1 ("expansion").

NCT ID: NCT05430854 Terminated - Clinical trials for Systemic Lupus Erythematosus

Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study

RECAST SLE OLE
Start date: June 1, 2022
Phase: Phase 2
Study type: Interventional

A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.

NCT ID: NCT05429762 Terminated - Neoplasm Clinical Trials

Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors

TusaRav-QT
Start date: October 3, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase1, single-arm study for treatment. This is a prospective multicenter, multinational, open-label study to assess the effect of tusamitamab ravtansine on the QT interval in participants with metastatic colorectal cancer (CRC), nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GEJ) adenocarcinoma for which in the judgement of the Investigator, no standard alternative therapy is available.

NCT ID: NCT05428709 Terminated - Breast Cancer Clinical Trials

Women In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology

WISER-WIN
Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The primary aim is to examine changes in tumor perfusion, oxygen saturation, and tumor physiology before and following acute physical activity in breast cancer patients. The secondary aim is to examine changes in circulating tumor DNA (ctDNA) levels before and following acute physical activity in breast cancer patients. The tertiary aim is to explore changes in circulating exerkines (cytokines and growth factors altered by exercise) before and following acute physical activity in breast cancer patients.

NCT ID: NCT05428215 Terminated - Gender Dysphoria Clinical Trials

Comparison of PKs of 17-Beta-Estradiol Via Sublingual Placement Versus Swallowing in Male-to-Female Transgender Patients

Start date: December 29, 2022
Phase: Phase 4
Study type: Interventional

This crossover study will investigate the pharmacokinetics of oral versus sublingual administration of 17-beta-estradiol in the trans-female population.