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NCT ID: NCT05569746 Completed - Clinical trials for Pediatric Kidney Disease

A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS

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

Hemolytic Uremic Syndrome (HUS) is a foodborne disease which mainly affects children. It is caused by Escherichia coli bacteria, which release a toxin called Shiga toxin within the body. This infectious form of HUS, defined as STEC-HUS, can cause sporadic cases or outbreaks, as observed in different countries. Argentina has the highest incidence of STEC-HUS worldwide. The disease is endemic, representing approximately 95% of all HUS cases nationwide. STEC-HUS generally begins with diarrhea (with or without blood), and can also cause fever, abdominal pain, and cramps. Then the child may have pallor, altered consciousness, decreased urine output, seizures, and other symptoms. Although death is uncommon (it occurs in 2-4% of cases), it is a very serious disease that mainly affects the kidneys, and also other organs such as the brain. About half of children need to undergo a risky procedure such as dialysis (due to malfunctioning kidneys); and most of them also receive blood transfusions. Around 30% of the patients are left with lifelong consequences that can range from permanent kidney damage to the need for a transplant. So far there is no drug, antibiotic or vaccine to prevent or treat HUS. Current treatment protocols include hospitalization for all patients with HUS, and supportive therapy such as hydration and salt intake. Support therapy is not a specific treatment, but rather helps the body better defend itself against the disease. The purpose of this study is to establish whether it is safe and effective to treat patients who are diagnosed with STEC-HUS, with INM004 (study drug). INM004 is an investigational product "Fraction F(ab')2 of Equine Shiga Antitoxin Immunoglobulin". It is a concentrated and sterile serum obtained from healthy horses immunized against Shiga toxin that contains antibodies capable of neutralizing it. The initial hypothesis is that INM004 would neutralize the entry of Shiga toxin into the body's cells thus preventing the consequent toxic damage. With the proposed treatment, INM004 would eliminate the Shiga toxin, preventing the progression of HUS symptoms and its serious complications (such as the need for and duration of dialysis, duration of hospital stays, as well as neurological, cardiovascular, intestinal complications, among others) which are associated with high morbidity and mortality. This treatment could then have an impact in health costs of STEC-HUS as well as the social costs.

NCT ID: NCT05568706 Recruiting - RSV Infection Clinical Trials

A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.

RSVHR
Start date: November 29, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2b, randomized, double-blind, placebo-controlled study of EDP-938 administered orally for the treatment of non-hospitalized adult subjects with confirmed RSV infection who are at high risk for complications after RSV infection.

NCT ID: NCT05568407 Terminated - Bladder Cancer Clinical Trials

A Study of Avelumab in Real-World Treatment for Patients With Advanced or Metastatic Urothelial Cancer

Start date: January 18, 2023
Phase:
Study type: Observational

This ambispective (both retrospective and prospective) NIS will evaluate the effectiveness and safety of Avelumab as a maintenance therapy administered after completion of first-line platinum-based chemotherapy in patients with locally advanced or metastatic urothelial cancer under routine conditions of daily clinical practice in Argentina and Brazil in line with the approved Avelumab label indication. Primary objective: • To evaluate overall survival (OS) rate at 12 and 24- months after the index date (date of the first Avelumab administration) in patients treated with Avelumab maintenance therapy. Secondary objectives: • To assess OS in patients treated with Avelumab maintenance therapy. To assess progression-free survival (PFS) of patients treated with Avelumab maintenance therapy. • To evaluate safety and tolerability of Avelumab maintenance therapy. • To assess duration of treatment (DOT) between the first and last dose of avelumab. • To describe the clinical and demographics characteristics of Argentinean and Brazilian patients treated with Avelumab maintenance therapy. Other objectives: • To evaluate anti-tumor effectiveness of Avelumab maintenance therapy.

NCT ID: NCT05568095 Active, not recruiting - Clinical trials for Advanced Upper Gastrointestinal Tract Adenocarcinoma

A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body

STAR-221
Start date: November 21, 2022
Phase: Phase 3
Study type: Interventional

This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

NCT ID: NCT05567796 Active, not recruiting - Obesity Clinical Trials

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

REDEFINE 1
Start date: November 1, 2022
Phase: Phase 3
Study type: Interventional

This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms. Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.

NCT ID: NCT05565742 Active, not recruiting - Clinical trials for Lipoprotein Disorder

A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]

Start date: October 20, 2022
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to determine the efficacy and safety of LY3819469 in adults with elevated lipoprotein(a). The study will lasts about 20 months.

NCT ID: NCT05565378 Recruiting - Clinical trials for Lung Cancer, Non-Small Cell

A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer

Start date: October 14, 2022
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PDy) of novel immunotherapy combinations compared with immunotherapy monotherapy in participants with Programmed death ligand-1 (PD L-1) high (Tumor cells [TC]/ Tumor proportion score [TPS] ≥ 50%), previously untreated, unresectable, locally advanced or metastatic NSCLC. Drug name mentioned as Belrestotug, GSK4428859A, and EOS884448 are all interchangeable for the same compound. In the rest of the document, the drug will be referred to as Belrestotug.

NCT ID: NCT05562466 Recruiting - Asthma Clinical Trials

A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma

Start date: May 11, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma. - The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks. - The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.

NCT ID: NCT05559580 Recruiting - Clinical trials for Scleroderma, Systemic

A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms

VITALISScE™
Start date: November 24, 2022
Phase: Phase 2
Study type: Interventional

This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma. The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems. Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months. During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects.

NCT ID: NCT05559359 Recruiting - Atopic Dermatitis Clinical Trials

A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

ADorable-1
Start date: October 18, 2022
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD).