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NCT ID: NCT05446870 Active, not recruiting - Ovarian Carcinoma Clinical Trials

Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)

Start date: July 25, 2022
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor DNA (ctDNA) at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + SOC therapy.

NCT ID: NCT05444257 Active, not recruiting - Cystic Fibrosis Clinical Trials

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy

Start date: November 8, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.

NCT ID: NCT05426499 Active, not recruiting - Clinical trials for Population Modeling of Anti-infective Drugs

Translational PKPD Modeling of Anti-infective Drugs Used in Pediatric Units.

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

Pharmacokinetic and pharmacodynamic modeling (PKPD) is becoming an essential tool for optimizing pharmacotherapy. Building mechanistic models allows determining the relationship between the dose, concentration, pharmacological effect, and side effects in various populations. The growing resistance to drugs among bacteria is a challenge for medicine, and the progress in pharmacometrics enables us to make rational clinical decisions. A particular group of patients is children with differences in PK and PD of drugs. The lack of clinical studies often forces to extrapolate dosing based on the results obtained in adults. In intensive care units, up to 70-90% of drugs in children are used off-label. Drug agencies point to the importance of the population-based approach to data analysis, especially in infants and children. Under the project, work will focus on the PK and PD of antifungal drugs (fluconazole, isavuconazole, and anidulafungin) and antibiotics (cefotaxime and meropenem) in the pediatric and adult populations. The choice of topic is dictated by the growing need to create PKPD models of the drugs mentioned above in children. The hypothesis is the assumption that using a mathematical model will enable to describe the time course of the drug in the organism, the relationship between the effect and the dose of the medicine and its concentration in the plasma, and the influence of individual factors on the PKPD profile of a drug.

NCT ID: NCT05425745 Active, not recruiting - Clinical trials for Hypercholesterolemia

Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

BROOKLYN
Start date: July 25, 2022
Phase: Phase 3
Study type: Interventional

This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).

NCT ID: NCT05421598 Active, not recruiting - Asthma Clinical Trials

Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma

TIDE-asthma
Start date: June 30, 2022
Phase: Phase 2
Study type: Interventional

This is a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma. Study details include: - The study duration (per participant) will be up to approximately 76 weeks for participants not going into LTS study and will be up to approximately 64 weeks for participants going into LTS study. - The randomized treatment duration will be up to approximately 60 weeks. - The scheduled number of visits will be 13.

NCT ID: NCT05413135 Active, not recruiting - Dyslipidemias Clinical Trials

Study of ARO-APOC3 in Adults With Dyslipidemia

Start date: July 7, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continue to meet eligibility criteria have the option to be enrolled into this study. Eligible enrolled participants will initially receive open-label ARO-APOC3 at the assigned dose level until a final dose is selected, at which point all participants will be transitioned to the selected dosing regimen.

NCT ID: NCT05407324 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

DAZALS
Start date: November 15, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).

NCT ID: NCT05405660 Active, not recruiting - Clinical trials for Chronic Inducible Urticaria

A Study of CDX-0159 in Patients With Chronic Inducible Urticaria

Start date: June 28, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.

NCT ID: NCT05405166 Active, not recruiting - Clinical trials for Plasma Cell Myeloma Recurrent

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

IRAKLIA
Start date: June 23, 2022
Phase: Phase 3
Study type: Interventional

This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

NCT ID: NCT05404282 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Start date: July 15, 2020
Phase: Phase 1
Study type: Interventional

This study evaluates the safety, pharmacokinetics, pharmacodynamics and efficacy of acalabrutinib and ceralasertib (known as AZD6738) when taken in combination.