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Filter by:The purpose of this study is to provide expanded access of patisiran to patients with hereditary transthyretin-mediated amyloidosis (hATTR).
This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to decrease elevated liver enzymes and direct bilirubin. This study aims to describe the response of PNALD after use of Omegaven by normalization of serum levels of liver enzymes and bilirubin.
The purpose of this study is to provide intravenous omega-3 fatty acids and monitor tolerance in subjects with prolonged parenteral nutrition dependence and parenteral nutrition-associated cholestasis through expanded access.
Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The purpose of this study is to provide access to SER-109 for adult subjects with recurrent Clostridioides Difficile Infection (RCDI) and to monitor subject safety and report to regulatory authorities, as appropriate.
The purpose of this study is to provide early access to Ibrutinib treatment for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and collect additional safety data while the medication is not commercially available.
A large proportion of Asian patients with HCC present with locally advanced or metastatic disease,at which point they are ineligible for curative treatments.Oxaliplatin plus fluorouracil/leucovorin intravenous infusion was proved effective in prolonging progression-free survival(PFS) than doxorubicin as palliative chemotherapy in patients with advanced HCC from Asia. Besides, hepatic arterial infusion chemotherapy (HAIC）is a widely used method for primary or metastasis liver tumor with high local tumor response. To our knowledge, there have not been any prospective studies to assess the safety and effecacy of HAIC using oxaliplatin plus fluorouracil/leucovorin for patients with locally advanced HCC.Thus,the purpose of this phase 2 study was to assess the safety and effecacy of HAIC using oxaliplatin plus fluorouracil/leucovorin for patients with locally advanced HCC.
The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated liver disease. It is a compassionate use protocol for patients who already have significant liver disease related to parenteral nutrition.
This clinical trial studies gemtuzumab ozogamicin in treating patients with relapsed or refractory acute myeloid leukemia or acute promyelocytic leukemia. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
To provide children dependent on total parenteral nutrition with Omegaven®, a fish oil-based intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable oil-based intravenous lipid emulsions, and that may therefore reduce the need for liver transplantation.
The purpose of this study is to provide patients who have relapsed or refractory Mantle Cell Lymphoma (MCL) with early access to an investigational medication called ibrutinib (PCI-32765) and to collect safety information about the drug.