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Last Updated: January 17, 2020

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CLINICAL TRIALS PROFILE FOR UDP-ALPHA-D-GLUCURONIC ACID

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Clinical Trials for UDP-alpha-D-glucuronic acid

Trial ID Title Status Sponsor Phase Summary
NCT00195637 Intravenous Immune Globulin to Treat Hereditary Inclusion Body Myopathy Completed National Human Genome Research Institute (NHGRI) Phase 1 This study will evaluate patients with Hereditary Inclusion Body Myopathy (HIBM) and examine the effects of immune globulin (IG) treatment on muscle and muscle function. HIBM is a progressive neuromuscular disease that begins in early adulthood, primarily affecting limb muscles. It results from mutations of the gene that is responsible for producing sialic acid, a sugar normally found on the surface of certain proteins, including alpha-dystroglycan, which is involved in muscle function. Some patients with HIBM have decreased sialic acid on the alpha-dystroglycan protein, which may be the cause of their muscle weakness. IG is a protein in the blood that carries a large amount of sialic acid. This study will administer IG to patients with HIBM and determine if the sialic acid in IG is taken up by muscle cells in these patients and if it can restore some of their muscle function. Four patients with HIBM will be admitted to this study at the NIH Clinical Center for evaluation and IG treatment. The evaluation lasts about 1 month. After completing baseline studies (see below), patients receive two intravenous doses of immune globulin (on days 6 and 7), followed by measurement of muscle strength 2 days later (day 9). They receive additional IG infusions on days 13, 20, and 27. A final set of tests is performed on day 29. Patients may leave the hospital on pass when no studies are being done. A patient's initial evaluation includes: - History and physical examination, neurological examination, eye examination - 24-hour urine collection - Blood tests on two separate days - Photographs showing the extent of muscle affected - Chest x-ray, electrocardiogram (EKG), and echocardiogram - Two muscle biopsies, one before and one after the IG treatments. For this procedure, a small sample of muscle tissue is surgically removed for examination under the microscope. - Muscle strength and endurance testing, including the following: The patient uses pulleys attached to machines that measure the strength of 24 different muscle groups The patient walks for 6 minutes and performs exercises To evaluate swallowing, the patient swallows a thick substance called barium The patient's tongue strength is measured using a specialized instrument. -Magnetic resonance imaging (MRI) of the muscles of the thigh or calf: MRI uses a magnetic field and radio waves to produce detailed pictures of organs and tissues. During the scan, the subject lies on a table in a narrow cylinder containing a magnetic field, wearing ear plugs to muffle loud noises that occur with electrical switching of the magnetic fields. He or she can speak with a staff member via an intercom system at all times during the procedure. The neurological and muscle strength and endurance evaluations are repeated on study days 9 and 29.
NCT00266149 Lamotrigine and Oral Contraceptives Terminated University of Aarhus Phase 3 The present study evaluates the effect of oral contraceptives on lamotrigine plasma concentrations in a double blind, placebo controlled, cross-over study in patients with epilepsy.
NCT00567567 Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma Active, not recruiting National Cancer Institute (NCI) Phase 3 This randomized phase III trial compares two different high-dose myeloablative chemotherapy regimens followed by autologous stem cell transplant as consolidation treatment of younger patients with high-risk neuroblastoma. All patients receive the same 6 cycles of initial multi-agent chemotherapy induction regimen. Peripheral blood stem cells are collected after the 2nd cycle of chemotherapy. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Patients underwent resection of their primary tumor mass after 5 cycles of chemotherapy. Those patients without progressive disease at completion of induction therapy who has sufficient stem cells collected and had adequate organ function were eligible to proceed to consolidation therapy. Those patients who met consolidation eligibility were randomized to either a single myeloablative regimen or 2 myeloablative regimens delivered in tandem followed by re-infusion of autologous stem cells. Patients received radiation therapy after recovery from the assigned myeloablative therapy. It is not yet known which regimen of high-dose chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.
NCT00567567 Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma Active, not recruiting Children's Oncology Group Phase 3 This randomized phase III trial compares two different high-dose myeloablative chemotherapy regimens followed by autologous stem cell transplant as consolidation treatment of younger patients with high-risk neuroblastoma. All patients receive the same 6 cycles of initial multi-agent chemotherapy induction regimen. Peripheral blood stem cells are collected after the 2nd cycle of chemotherapy. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Patients underwent resection of their primary tumor mass after 5 cycles of chemotherapy. Those patients without progressive disease at completion of induction therapy who has sufficient stem cells collected and had adequate organ function were eligible to proceed to consolidation therapy. Those patients who met consolidation eligibility were randomized to either a single myeloablative regimen or 2 myeloablative regimens delivered in tandem followed by re-infusion of autologous stem cells. Patients received radiation therapy after recovery from the assigned myeloablative therapy. It is not yet known which regimen of high-dose chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.
NCT01141322 Cholestatic Drug-induced Liver Injury Unknown status Taipei Veterans General Hospital, Taiwan Phase 4 Cholestatic drug-induced liver injury (DILI) is the severe form of DILI with a grave outcome. Drug-metabolizing enzymes play an important role in the metabolism of drugs. The genetic polymorphism of drug-metabolizing enzymes may influence the activities and expression of these enzymes and thereby affect the susceptibility and severity of DILI. UDP-glucuronosyltransferase (UGT) is an important phase 2 detoxification enzyme, which is related to congenital hyperbilirubinemia. Recently, the genetic polymorphism of UGT1A1 was reported to be associated with jaundice induced by some drugs, and UGT1A7 was shown to be related to the susceptibility of hepatocellular carcinoma and other cancers. Ursodeoxycholic acid (UDCA ) is a hydrophilic bile acid that is increasingly used for the treatment of various cholestatic disorders. The aims of this study are (1) to assess the association of the genetic polymorphism of UGT1A1 and 1A7, and the susceptibility and severity of drug-induced liver injury (DILI), with emphasis on the cholestatic DILI; (2) to evaluate the treatment effect of UDCA in the DILI, with special reference to the cholestatic hepatotoxicity.
NCT01634750 Phase I Clinical Trial of ManNAc in Patients With GNE Myopathy or Hereditary Inclusion Body Myopathy (HIBM) Completed National Center for Advancing Translational Science (NCATS) Phase 1 Background: - Hereditary inclusion body myopathy (HIBM) is a genetic disorder caused by mutations in a gene called GNE. This gene is responsible for producing a sugar called sialic acid. Low levels of sialic acid may cause muscle problems. Symptoms of HIBM include walking difficulties and muscle weakness, which usually start in a person s 20s or 30s and become worse over time. Researchers are studying a drug called ManNAc. It may be useful for treating HIBM. However, this drug is still being tested. Researchers want to see how ManNAc is absorbed into and removed from the blood. They will not be looking specifically at whether ManNAc can stop or slow the symptoms of HIBM. Objectives: - To study how MaNAc is absorbed into and removed from the blood in people with HIBM. - To study of safety of ManNAc in people with HIBM. Eligibility: - Individuals between 18 and 70 years of age who have HIBM. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. - Participants will have a 3 to 4-day inpatient stay for the main part of the study. - Participants will be divided into groups of six. In each group, four will take ManNAc and two will take a placebo. Participants will not know which one they will receive. - Participants will have a single dose of either ManNAc or placebo. They will be monitored for any possible side effects. Frequent blood samples will be collected during the 4-day stay. - No treatment for HIBM will be provided as part of this study.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for UDP-alpha-D-glucuronic acid

Condition Name

Condition Name for
Intervention Trials
Localized Unresectable Neuroblastoma 1
Localized Resectable Neuroblastoma 1
Hereditary Inclusion Body Myopathy (HIBM) 1
Stage 4S Neuroblastoma 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Muscular Diseases 2
Distal Myopathies 2
Hepatitis 1
Drug-Induced Liver Injury 1
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Clinical Trial Locations for UDP-alpha-D-glucuronic acid

Trials by Country

Trials by Country for
Location Trials
United States 47
Canada 7
Australia 3
Taiwan 1
Puerto Rico 1
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Trials by US State

Trials by US State for
Location Trials
Maryland 3
Kansas 1
Missouri 1
Mississippi 1
Minnesota 1
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Clinical Trial Progress for UDP-alpha-D-glucuronic acid

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 2
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for UDP-alpha-D-glucuronic acid

Sponsor Name

Sponsor Name for
Sponsor Trials
National Human Genome Research Institute (NHGRI) 2
University of Aarhus 1
Therapeutics for Rare and Neglected Diseases (TRND) 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
NIH 5
Other 3
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