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Набира участници Фаза 2/3

A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

Systemic Sclerosis Associated Interstitial Lung Disease Scleroderma, Systemic

This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).

Начало: 13.09.2023 Край: 12.07.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +14 GlaxoSmithKline NCT05878717

Набира участници Фаза 3

Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)

Community-acquired Pneumonia

The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.

Начало: 09.09.2023 Край: 31.07.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +14 Biotest NCT05722938

Набира участници

Comparison of Uncomplicated Candidemia Therapy Duration in Children

Invasive Candidiasis

The goal of this clinical trial is to compare antifungal therapy duration in pediatric uncomplicated candidemia. The specific aims are: * Compare the desirability of outcome ranking in children with uncomplicated candidemia randomized to 7 additional days of antifungal therapy (standard-course) versus no additional antifungal therapy (short-course) after already receiving 7 days of echinocandin therapy. * Compare the 14-day desirability of outcome measure for subjects with a negative and those with a positive T2Candida® biomarker at day 7 of therapy within randomized groups. Participants meeting eligibility criteria will be approached and consented between day 5 and 7 of primary systemic antifungal therapy. On day 7 of primary systemic antifungal therapy, inclusion and exclusion criteria will again be reviewed for consented patients and those still eligible will be randomized 1:1 to the two study arms. Researchers will compare no additional antifungal therapy (short-course) versus 7 additional days of systemic antifungal therapy (standard-course) in pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy to see if shorter durations are as effective as longer durations in treating uncomplicated candidemia.

Начало: 08.09.2023 Край: 30.06.2032 Възраст: от 120 г. Лечение

Australia, United States Arkansas Children's Hospital Research Institute NCT05763251

Набира участници Фаза 3

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

Metastatic Breast Cancer

This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).

Начало: 08.09.2023 Край: 28.12.2032 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +25 Hoffmann-La Roche NCT05894239

Набира участници Фаза 1

A Study of INI-822 in Healthy Volunteers and Participants with Non-alcoholic Steatohepatitis (NASH) or Presumed NASH

Non-alcoholic Steatohepatitis

This Phase 1 trial will explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of INI-822 in healthy volunteers in Parts A, B, and D and in participants with a history of NASH or presumed NASH in Part C.

Начало: 08.09.2023 Край: 15.06.2025 Възраст: 18–65 г. Лечение

Australia Inipharm Australia Pty Ltd NCT05945537

Набира участници Фаза 3

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

Primary Biliary Cholangitis

To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

Начало: 07.09.2023 Край: 01.08.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +22 Gilead Sciences NCT06051617

Набира участници Фаза 1

IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas

B-cell Non-Hodgkin Lymphoma Diffuse Large B Cell Lymphoma Follicular Lymphoma Mantle Cell Lymphoma +1

This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL).

Начало: 05.09.2023 Край: 01.09.2028 Възраст: от 18 г. Лечение

Australia, Canada, Italy +2 Iksuda Therapeutics Ltd. NCT05365659

Набира участници Фаза 3

A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis

Primary Biliary Cholangitis (PBC)

The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant. The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death). This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.

Начало: 31.08.2023 Край: 31.05.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +21 Ipsen NCT06016842

Набира участници Фаза 3

A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.

Ph+ ALL

A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of Olverembatinib combined with chemotherapy versus Imatinib combined with chemotherapy in subjects with newly diagnosed Ph+ALL.

Начало: 31.08.2023 Край: 31.10.2028 Възраст: от 18 г. Лечение

Australia, China Ascentage Pharma Group Inc. NCT06051409

Набира участници Фаза 1/2

Study of AVZO-021 in Patients With Advanced Solid Tumors

Advanced Solid Tumor HR+/HER2- Breast Cancer HR+, HER2-, Advanced Breast Cancer CCNE1 Amplification +5

This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).

Начало: 30.08.2023 Край: 31.01.2030 Възраст: от 18 г. Лечение

Australia, United States Avenzo Therapeutics, Inc. NCT05867251

Набира участници Фаза 3

A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations

Asthma

The primary objective of the study is to assess the efficacy of high dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs). Secondary Objectives: To evaluate the efficacy of Fp/ABS low dose compared to ABS and the effect on systemic corticosteroid (SCS) exposure To evaluate the safety and tolerability of Fp/A BS The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 42 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria

Начало: 30.08.2023 Край: 31.10.2026 Възраст: от 4 г. Лечение

Argentina, Australia, Bulgaria +18 Teva Branded Pharmaceutical Products R&D LLC NCT06052267

Набира участници Фаза 2

A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis

Atopic Dermatitis

The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis (AD). AD is a long- lasting itchy red rash, caused by a skin reaction. This study is seeking participants who: * are 18 years of age or more. * Were confirmed to have AD at least 6 months ago. * Are not having an effective treatment result from medicines that are applied on skin for AD. * Are considered by their doctors to have moderate to severe AD. In Stage 1 of the study, participants will receive either PF-07275315 or PF-07264660 or placebo. Stage 1 is complete. In Stage 2 of the study participants will receive either PF-07275315 or placebo. In Stage 3 of the study participants who have received anti-inflammatory proteins, will receive either PF-07275315 or placebo. In Stage 4 of the study participants will receive either PF-07264660 or placebo. A placebo does not have any medicine in it but looks just like the medicines being studied. PF-07275315 or PF-07264660 or placebo will be given as multiple shots in the clinic over the course of each Stage. The experiences of people receiving PF-07275315 or PF-07264660 will be compared to people who do not. This will help determine if PF-07275315 and PF-07264660 are safe and effective. Participants in Stages 1, 2 and 4 will be involved in this study for up to 40 weeks (10 months). Participants in Stage 3 will be involved in this study for up to 52 weeks (13 months).

Начало: 22.08.2023 Край: 08.03.2027 Възраст: от 18 г. Лечение

Australia, Canada, China +4 Pfizer NCT05995964

Набира участници Фаза 3

A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients

BK Viremia Kidney Transplant Infection Kidney Transplant Failure and Rejection

BEAT-BK will see the effect of immunosuppression reduction/modification with and without IVIG on BKPyV infection, allograft function, allograft loss, acute transplant rejection, immunosuppression load and death in kidney and simultaneous kidney pancreas transplant recipients with polyomavirus infections (BKPyV).

Начало: 18.08.2023 Край: 30.06.2029 Възраст: от 2 г. Лечение

Australia The University of Queensland NCT05325008

Набира участници Фаза 1/2

A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors

Advanced Solid Tumors

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.

Начало: 17.08.2023 Край: 01.05.2028 Възраст: от 18 г. Лечение

Australia, China, Taiwan +1 DualityBio Inc. NCT05914116

Набира участници Фаза 2

The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)

Chronic Rhinosinusitis (Diagnosis)

To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.

Начало: 17.08.2023 Край: 01.06.2025 Възраст: 18–80 г. Лечение

Australia Oticara Australia PTY LTD NCT05882903

Набира участници

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

Cardiac Arrest With Successful Resuscitation Hypoxia, Brain

The STEPCARE-trial is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac arrest and who are comatose. It will include three different interventions focusing on sedation targets, temperature targets and mean arterial pressure targets.

Начало: 17.08.2023 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, Belgium, Estonia +11 Region Skane NCT05564754

Набира участници

A Personalised Approach Utilising the Frailty Index to Empower Consumers

Gastrointestinal Diseases

Frailty is a common clinical syndrome in older adults that may carry an increased risk for poor health outcomes including falls, hospitalisation, and mortality. Having a colonoscopy can be associated with potential adverse outcomes in frail patients. At present, however, frailty is not routinely assessed in gastroenterological clinical practice. In a prospective randomised controlled study consenting patients over 65 years at the Princess Alexandra Hospital will receive either a) personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer or b) current standard practice in regards to having a surveillance colonoscopy to determine the effects on patient satisfaction and percentage of colonoscopies avoided.

Начало: 14.08.2023 Край: 01.02.2026 Възраст: 65–100 г. Скрининг

Australia Princess Alexandra Hospital, Brisbane, Australia NCT05292989

Набира участници Фаза 1

A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)

Relapsed or Refractory Multiple Myeloma

The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.

Начало: 10.08.2023 Край: 31.07.2027 Възраст: от 18 г. Лечение

Australia, Israel, South Korea Genentech, Inc. NCT05927571

Набира участници Фаза 2

Reboxetine for Sleep Apnoea After ENT Surgery

Sleep Apnea, Obstructive

This pilot study will establish the feasibility of a larger trial to investigate whether reboxetine, a medication used to treat depression, can reduce the severity of obstructive sleep apnea (OSA) including increased blood oxygenation in post-surgical OSA patients where positive airway pressure (CPAP) therapy is either frequently poorly tolerated or not an option immediately post surgery. In this randomized, placebo-controlled, double-blind study, participants will use at-home sleep monitoring equipment before and after surgery plus measures of oxygenation. They will be prescribed either reboxetine or a placebo for seven days after surgery and complete questionnaires at the beginning and end of the study.

Начало: 10.08.2023 Край: 01.07.2025 Възраст: от 18 г. Друго

Australia Flinders University NCT05978505

Набира участници Фаза 3

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

Primary IgA Nephropathy

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of sefaxersen (RO7434656), a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care.

Начало: 08.08.2023 Край: 31.03.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +18 Hoffmann-La Roche NCT05797610

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