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NCT ID: NCT05076149 Completed - Cystic Fibrosis Clinical Trials

A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation

Start date: October 27, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, or have at least 1 other TCR CF transmembrane conductance regulator (CFTR) gene mutation and no F508del mutation.

NCT ID: NCT05075499 Recruiting - Multiple Sclerosis Clinical Trials

Immune Response to COVID-19 Vaccine in Multiple Sclerosis Patients Treated With Teriflunomide and Alemtuzumab

Start date: March 20, 2021
Phase: N/A
Study type: Interventional

Phase IV, 3-armed, prospective, open-label, single-center, Israeli study, examining the response to SARS-CoV-2 vaccination in 30 teriflunomide-, 10 alemtuzumab-treated patients, and 30 age-matched (for the teriflunomide group) untreated MS patients. Treatments will be administered according to common local practice. Demographic, clinical, treatment-related and COVID-19-related data will be collected. Blood samples will be drawn for each participant at baseline (before COVID-19 vaccination), and at 1, 3, 6, (and possibly 12) months post 2nd dose of COVID-19 vaccine. Humoral, B-cell and T-cell responses will be evaluated.

NCT ID: NCT05073640 Recruiting - Schizophrenia Clinical Trials

Pentoxifylline Add-on Therapy for Schizophrenia

Start date: April 20, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The etiology and pathogenesis of schizophrenia remain unclear. The immune dysfunction hypothesis for schizophrenia has attracted increasing attention from researchers, and substantial evidence suggested that the levels of TNF-α and other cytokines are markedly elevated in patients with schizophrenia. The investigators aim to evaluate the adjuvant therapeutic effect of Pentoxifylline, a TNF-α inhibitor that crosses the blood-brain barrier, in a randomized, double-blind, 6-week trial. Individuals with schizophrenia will receive either Pentoxifylline or a matching placebo as an add-on treatment to antipsychotic agents. Subjects' positive and negative symptoms and plasma concentration of neuroinflammatory markers will be monitored at baseline and every two weeks until the end of the trial.

NCT ID: NCT05073458 Terminated - Clinical trials for Warm Autoimmune Hemolytic Anemia (wAIHA)

Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia

PATHWAY
Start date: March 15, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of parsaclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA),

NCT ID: NCT05071339 Recruiting - IVF Clinical Trials

GnRH Antagonist Pre-treatment for the Prevention of Asynchronous Follicular Growth

Start date: April 1, 2021
Phase: Phase 4
Study type: Interventional

In the study the investigators would like to examine the effect of GnRH antagonist administration at the beginning of the follicular phase in patients presenting with high baseline estradiol levels of 200 pmol/L or above with a leading follicle of 11-13 mm. In the unit's practice, patients presenting for cycle initiation with a leading follicle > 10 in the presence of E2 > 200 pmol/L (54 pg/ml) are deferred and receive a priming antagonist protocol in their sequential cycle. The aim of this intervention is to suppress FSH levels at the beginning of the cycle thus preventing estradiol secretion of the leading follicle. This may contribute to better synchronization of the remaining antral follicles cohort and allow for a better cycle outcome instead of cancellation or one-month postponement. As previous studies using GnRH antagonist pre-treatment prior to GT initiation for synchronization purposes demonstrated positive results (including different patient population) , no deleterious effects are expected.

NCT ID: NCT05070364 Active, not recruiting - Clinical trials for Hepatitis Delta Virus

Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV

LIMT-2
Start date: December 21, 2021
Phase: Phase 3
Study type: Interventional

The Phase 3 LIMT-2 study will evaluate the safety and efficacy of Peginterferon Lambda treatment for 48 weeks with 24 weeks follow-up compared to no treatment for 12 weeks in patients chronically infected with HDV. The primary analysis will compare the proportion of patients with HDV RNA < LLOQ at the 24-week post-treatment visit in the Peginterferon Lambda treatment group vs the proportion of patients with HDV RNA < LLOQ at the Week 12 visit in the no-treatment comparator group.

NCT ID: NCT05068284 Terminated - Crohn's Disease Clinical Trials

A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease

AIM-CD
Start date: January 31, 2022
Phase: Phase 2
Study type: Interventional

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active CD. Adverse events and change in the disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of CD. In the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. Around 265 participants 18-75 years of age with moderately to severely active CD will be enrolled in the study at approximately 200 sites worldwide. The study is compromised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non-responders or a 40-week double-blind placebo-controlled maintenance period for responders. In the maintenance period, responders will be randomized to receive subcutaneous placebo or ABBV-154 in 2 different doses every other week. Participants in the placebo group who are initial responders will receive ABBV-154 in the maintenance period. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05067959 Active, not recruiting - Covid19 Clinical Trials

Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases

Start date: December 28, 2020
Phase:
Study type: Observational

The 2019-coronavirus disease (COVID-19), caused by SARS-CoV-2, was identified as the source of pneumonia cases in Wuhan city in China. It rapidly spread worldwide and was declared by WHO as a pandemic. COVID-19 vaccines are expected to be the breakthrough in controlling the pandemic. However, studies performed only in healthy adults, and specifically excluded patients who were under immunomodulatory/biologic therapy, thus excluding patients with chronic inflammatory diseases (IBD). In this study we wish to understand vaccine efficacy and immunological response in IBD patients.

NCT ID: NCT05067803 Completed - Cardiac Disease Clinical Trials

Study for the Assessment of USEG Software.

Start date: December 24, 2021
Phase:
Study type: Observational

The product is comprised of software that aids in automated guided ultrasound image acquisition for novice users (medical professional without experience in performing echocardiography, e.g. nurses, physicians assistants, medical doctors, medical student etc.). The software provides real-time feedback during image acquisition to optimize image capture and determine whether image quality is sufficient for medical evaluation. The software is designed to be used with any echocardiographic ultrasound system. The Philips Lumify hand-held ultrasound device will be used for this study. - Images can be acquired manually by a novice user. - Each novice user will have a training course of 8 hours, before the study commences.

NCT ID: NCT05067283 Recruiting - Clinical trials for Advanced Solid Tumors

A Study of MK-1084 in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

Start date: December 17, 2021
Phase: Phase 1
Study type: Interventional

This is a study evaluating the safety, pharmacokinetics, and efficacy of MK-1084 alone, and MK-1084 plus other combination therapies in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation.