UC Davis Health Clinical Studies

Clinical Study of Inhaled Experimental GB002 for Pulmonary Arterial Hypertension (PAH)

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GB002 is an experimental (not yet approved by the FDA) drug. GB002 blocks receptors in the body that are associated with PAH. By reducing the activity of these receptors, the researchers think GB002 may reduce the progression of PAH and make blood vessels in the body larger, to reduce the higher blood pressure in the lungs. The purpose of this study is to test the safety of GB002 at different dose levels. We (the Study Doctor and study staff and sponsor) want to find out what effects, good and/or bad, GB002 has on you and your PAH. We also want to measure levels of GB002 and other biomarkers in your blood and mucosal tissues of the nose. Biomarkers are substances in your blood or mucosal tissue of the nose that help us understand how your body is reacting to the study medication. Your voluntary participation in this research study may help to determine whether GB002 is safe when given to people with PAH.

Drug study, Phase 1
Any, age 18 to 75 years old

A Study of Experimental Tezepelumab for Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

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This study will test the experimental medication tezepelumab (study drug). We hope to learn if it will work and be safe as a medication to treat moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). “Experimental” means that the study drug is currently being tested. To do this, tezepelumab will be compared with placebo. Tezepelumab blocks a chemical that is responsible for inflammation that occurs in the lung. This is a part of how COPD affects the lungs. The placebo will be like tezepelumab but will not contain any active medication. Study drug and placebo will be referred to as “study medication” throughout this text. The study medication will be administered as an injection under your skin every 4 weeks. Tezepelumab is not approved by the FDA, except for use in research studies like this.

Biological study, Phase 2
Any, age 40 to 80 years old

Dose-Range Finding Study of the Effectiveness and Safety of Experimental QBW251 for COPD

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The purpose of this research study is to test the experimental study drug, QBW251. It will be added to the current maximal standard therapy for COPD. We hope to learn if it can improve your lung function compared to standard therapy alone. This drug targets part of the airways to help reduce the thickness of mucus in the lungs. This makes it easier to get out of lung. This study will also investigate the best dose for QBW251. The best dose is where the benefits would outweigh any possible side effects or risks. To perform this comparison, all patients will receive the same standard treatment. It is a combination of all three following medications, sometimes referred to as “triple combination” or “triple therapy: • Long-acting beta-2 agonist (LABA)- this medicine opens the airways in the lungs by relaxing the smooth muscle around the airways. • Long-acting muscarinic receptor antagonist (LAMA). This is similar to the LABA medicine. It opens up the airways in the lungs by relaxing the smooth muscle around the airways. It does so via a different mechanism than LABA. • Inhaled corticosteroid (ICS). This medicine works by reducing inflammation, swelling, and mucus production in the airways.

Drug study, Phase 2
Any, age 40 years or older

A Study of the Experimental PET/CT Radiotracer "18F-avb6-Binding-Peptide" After COVID-19 (Coronavirus) Infection

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Researchers at UC Davis have developed a new drug to aid in the detection of lung damage. This drug is called a “radiotracer." It attaches to damaged cells and shines a light that can be seen using a special camera, called a “positron emission tomography” or “PET” scanner. We hope this new radiotracer will improve the ability to locate possible lung damage. This new radiotracer is called Fluorine-18 Alpha-V Beta-6 Binding Peptide.

Other Study
Any, age 18 years and older

A Study to Test the Activity and Safety of Experimental Selinexor (KPT-330) for Severe COVID-19 (Coronavirus) Infection

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Coronavirus disease 2019 (COVID-19) is caused by the single stranded RNA virus (SARS-CoV2). It may also cause an inflammatory response. This inflammation is harmful to your health. It can lead to: - multiorgan dysfunction (altered function of various organ systems such as heart, lung, and kidney), - respiratory failure and - even death. A protein called exportin 1 (XPO1) has been shown to be important in both the virus lifecycle and the inflammation caused by the virus. Inhibition of XPO1 by selinexor could lead to both anti-viral and anti-inflammatory activity. Selinexor is approved by the FDA for the use in certain patients with a type of cancer called multiple myeloma. It is considered experimental for use in COVID-19. Experimental means that it has not been approved by the FDA for the treatment of COVID-19.

Drug Study
Any, age 18 years and older

Serologic (blood-based) Response of COVID-19 (Coronavirus) Patients

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The novel coronavirus (COVID19) has caused a global pendemic. Some patients have had symptoms and were tested for the infection. Many others developed immunity from the virus, but never had symptoms. These patients can be identified by an antibody test (blood test). These are new tests and the accuracy of them has not been determined. We are asking for blood from patients who have been tested for COVID-19 to determine how well these new antibody blood tests work. We also would like to see how your immune system responded to the infection and arealso asking for saliva samples for testing of antibodies. Blood cells will be taken and in the lab exposed to the virus to see how they kill this new virus. We will also look at your blood cells under a microscope to see if there are any abnormalities.

Other Study
Any, age 18 years and older

Outcomes Related to COVID-19 (Coronavirus) Treated with Hydroxychloroquine Among In-Patients with Symptomatic Disease

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We think hydroxychloroquine might help the body recover from COVID-19. We do not have enough information to know if it makes COVID-19 better or worse or has no effect. In laboratory studies, it appears that hydroxychloroquine can help kill the COVID-19 virus. Sometimes drugs that look like they might work in laboratory studies do not actually work when given to people. Some people who take hydroxychloroquine have side effects (things that the drug does that are not helpful and can be harmful). We do not know whether taking hydroxychloroquine: - is overall helpful, - is overall harmful, or - has no effect when it is taken for COVID-19. This study will test if hydroxychloroquine helps people recover from COVID-19.

Drug Study
Any, age 18 years or older

Safety, Tolerability, and Effect of Experimental ARO-AAT on the Liver and Blood For Alpha-1 Antitrypsin (AAT) Deficiency

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Alpha-1 Antitrypsin (AAT) is a naturally occurring protein. It helps to protect lungs from inflammation. Normal AAT, also known as M-AAT, works by turning off an enzyme called neutrophil elastase. Neutrophil elastase can become activated when the lungs are irritated or inflamed. A mutation in the AAT gene (a change in the body’s genetic instructions on how to make AAT) causes it to be made incorrectly. This means that very little of it gets into the bloodstream. Even if it makes it into the bloodstream, the poorly made AAT does not turn off neutrophil elastase very well. This causes breakdown of normal lung tissue, causing lung damage known as emphysema. Also, as AAT is mainly manufactured in the liver, incorrectly made AAT can accumulate and clog up liver cells, causing liver damage. These most abnormal AAT proteins are called Z-AAT. Subjects with genetic instructions for Z-AAT are at the greatest risk for AATD related lung and liver disease. ARO-AAT is a drug being developed by a company called Arrowhead Pharmaceuticals, Inc. ARO-AAT is investigational (experimental), which means that it is not approved by the FDA. In a patient with AATD, ARO-AAT may stop the mutated protein from being made. In animal studies, ARO-AAT has been shown to reduce the levels of abnormal AAT protein in the blood and in the liver. ARO-AAT given to human volunteers has been shown to decrease levels of AAT in the blood. This is thought to show that there is reduced production of AAT by the liver. This study is being carried out to see how safe and well tolerated ARO-AAT is. The study team hopes to see if low, medium and high doses of the study treatment will decrease Alpha-1 Antitrypsin in the blood and in the liver. Study treatment will be compared to a placebo, or dummy injection. A dummy treatment looks like a genuine medicine but contains no active ingredient.

Drug study, Phase [/2/,/ /3/]
Any, age 18 to 75 years old
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