UC Davis Health Clinical Studies

A Study of the Long-term Safety of Experimental Tafamidis For Transthyretin Cardiomyopathy

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You have been diagnosed with transthyretin amyloid cardiomyopathy. This is a life-threatening disease involving misfolded protein in the heart. Symptoms include: heart failure, manifested by dyspnea, fatigue, orthostatic hypotension, and/or syncope. Currently there are no FDA approved therapies specific to treating amyloid cardiomyopathy. In a clinical trial, experimental tafamidis was shown to be superior to placebo. It reduced the rate of hospitalizations from cardiac events. It also reduced the rate of death from this disease. The trial enrollment period has ended for this trial. Pfizer is currently pursuing approval in the United States of this drug for TTR amyloid disease. It is not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory agency in the United States. During this study, you will be monitored by your physician in clinic to see how well you are responding to the study drug. The safety of tafamidis will also be evaluated by tracking any adverse events.

Drug study, Phase 3
Any, age 18 years or older

A Study of Experimental Apixaban for Venous Thromboembolism (deep vein blood clot) in Children

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This research study will test the safety and effectiveness of the experimental medicine apixaban. Experimental apizaban is a new anti-clotting drug. It will be used in the treatment of these blood clots in children. Children in this study may receive either standard treatment or apixaban. Children who receive standard treatment may receive drugs currently used by doctors to treat blood clots. These drugs include: - vitamin K antagonists (drugs that keep the body from making proteins used in making blood clots) - low molecular weight heparins and unfractionated heparin (which prevent the body from making blood clots) The use of apixaban in this study is experimental because apixaban is not currently approved by the FDA to treat blood clots in children. However, it is approved to treat blood clots in adults.

Drug study, Phase 4
Any, age Up to 17 years old

A Dose Confirmation Study of Experimental AAV5-hFIXco-Padua for Adults with Moderate-to-Severe Hemophilia B

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The purpose of this study is to confirm the safety and effectiveness of a single infusion of experimental AMT-061. It will be given to adults with severe or moderately severe hemophilia B. This is the first study testing AMT-061 in humans. However, AMT-061’s predecessor AMT-060 has been tested in 10 patients in an ongoing study. AMT-061 is nearly identical to AMT-060, they only differ by a single amino acid representing the naturally occurring Factor IX Padua variant. This ongoing study with AMT-060 has entered a third year of follow-up for patients who received AMT-060. In total, this study will follow patients for 5 years from single treatment. At both doses evaluated, AMT-060 appears to be safe and well-tolerated. There was no loss of Factor IX activity, no immune responses and no development of Factor IX inhibitors for any of the 10 patients in the study. AMT-061 is expected to have higher Factor IX activity levels than observed with AMT-060. We are doing this study with the same dose of AMT-061 as used with AMT-060 to see if that is true. It is expected that AMT-061 will have a similar safety profile as AMT-060.

Genetic study, Phase 2
Male, age 18 years or older

A Study of the Safety and Activity of Experimental ABBV-744 For Metastatic Prostate Cancer and Acute Myeloid Leukemia

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This is a research study for an experimental drug called ABBV-744. It will be studied in patients with relapsed/refractory acute myeloid leukemia (AML). An investigational drug is one that has not been approved by the FDA. The purpose of this study is: - to see if ABBV-744 is safe - to determine a safe dose of ABBV-744 - to see how much ABBV-744 is in your blood at various times (these tests are called "pharmacokinetics" or "PK") - to determine if treatment with ABBV-744 leads to tumor shrinkage. This study is for patients with relapsed (cancer has returned) or refractory (cancer is not responding to treatment) acute myeloid leukemia. The study sponsor (AbbVie) requests that we site collect tissue samples (including blood samples and tumor biopsies) for research purposes. This can help researchers (including your doctor and AbbVie) to better understand why certain people respond differently to ABBV-744. This is called “biomarker” research. ABBV-744 is a drug called a Bromodomain and extra-terminal (BET) inhibitor. BET proteins read DNA modifications that determine which genes are active. ABBV-744 interferes with this reading. If reading such DNA modifications are needed for the survival and growth of cells in a tumor, the tumor may be slowed or stopped.

Drug study, Phase 1
Any, age 18 years or older

Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute...

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The standard treatment for Ph+ ALL is based on therapy used by the European “EsPhALL” group. It consists of a chemotherapy backbone combined with a TKI, and has many side effects. This study looks at how well a different chemotherapy given together with a TKI drug called imatinib works. It will be given to children and young adults with Ph+ ALL. This combination is experimental. The overall goal of this study is to compare the effects of a less intensive chemotherapy backbone combined with imatinib on children and young adults with Ph+ ALL. In this study you will get either the standard chemotherapy backbone together with imatinib, or the less intensive chemotherapy backbone with imatinib. You will not get both.

Procedure study, Phase 3
Any, age 2 to 21 years old
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