ANTICUERPOS ANTIMITOCONDRIALES PDF – La presencia de anticuerpos antimitocondriales es casi constante, lo que constituye su. ANTICUERPOS ANTIMITOCONDRIALES PDF DOWNLOAD – La presencia de anticuerpos antimitocondriales es casi constante, lo que. ANTICUERPOS ANTIMITOCONDRIALES PDF – Los anticuerpos antimitocondriales tienen una sensibilidad de 95% para la PBC primaria de.
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Clinical trials The European Union Clinical Trials Register allows you to search for protocol and results information on: Cancer AND drug name. Pneumonia AND sponsor name. How to search [pdf]. For these items you should use the filters and not add them to your search terms in the text field. Trials with results Trials without results Clear advanced search filters.
Review by the Competent Authority or Ethics Committee in the country concerned. EU Clinical Trials Register. Both Female Only Male Only. IMP with orphan designation in the indication. Annticuerpos with results Trials without results.
Clear advanced search filters. Date on which this record was first entered in the EudraCT database:. Title of antimitocondria,es trial for lay people, in easily understood, i. A Phase 3b clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cirrhosis.
The IMP has been designated in this indication as an orphan drug in the Community. Committee on Advanced therapies CAT has issued a classification for this product. Combination product that includes anrimitocondriales device, but does not involve an Advanced Therapy.
Primary Biliary Cirrhosis is a rare, chronic autoimmune liver disease characterized by both liver and biliary tract lesions that progress to cirrhosis and other complications. To assess the effect of OCA compared to placebo, in conjunction with established local standard of care, on clinical outcomes in subjects with primary biliary cirrhosis PBC as measured by time to first occurrence of any of the following adjudicated events, derived as a composite event endpoint: Model of end stage liver disease MELD score?
Hospitalization as defined by a stay of 24 hours or greater for new onset or recurrence of: Encephalopathy as defined by a West Haven score of?
Spontaneous bacterial peritonitis confirmed by diagnostic paracentesis. Uncontrolled ascites antiicuerpos resistant ascites requiring therapeutic paracentesis at a frequency of at least twice in a month. Hepatocellular carcinoma confirmed by 2 complimentary imaging modalities. Fallecimiento por cualquier causa b.
To assess the effect of OCA compared to placebo on time to first occurrence of each individual component of the primary endpoint as listed above and also to include liver anticuerps death.
To assess the effect of OCA compared to placebo on anhicuerpos progression via the antticuerpos Markers of inflammation and fibrosis 3. To assess the effect of OCA compared to historical controls on liver-related clinical outcomes. To assess the pharmacokinetics of OCA and its conjugates in a subset of subjects.
To assess health outcomes and pharmacoeconomics including cost-effectiveness, resource utilization, and antimifocondriales of life measures in subjects treated with OCA compared to placebo. To assess the safety and tolerability in subjects treated with OCA compared to placebo. Evaluar la seguridad y la tolerancia en sujetos tratados con AOC comparadas con el placebo.
The following title is mentioned in the Patient Informed Consent but not on the protocol where a description of the genetic s study is contained: Genetics samples will be collected at Day 0 and every other year beginning at Month A genetics study for single-nucleotide polymorphisms SNPs that may be involved in PBC will be conducted for subjects and at antimitoconndriales sites willing to provide samples at Day 0, Month 12, and every other year at the yearly visits thereafter.
RNA expression resulting from treatment with OCA will be assessed at indicated timepoints during the study. Subjects will be permitted to decline to provide a blood sample for the genetics study, without affecting their involvement in the study. Clinical Research Ethic antjmitocondriales review and approval will be required and willing subjects must specifically consent to participate in this evaluation.
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The samples will be stored for up to 1 year after the end of the study and destroyed after 1 year if not analyzed. Female subjects must be postmenopausal, surgically sterile, or if premenopausal and not surgically sterilebe prepared to use? Effective methods of contraception are considered to be those listed below: Must provide written informed consent and agree to comply with the study protocol.
Los sujetos deben otorgar su consentimiento informado por escrito y aceptar cumplir el protocolo del estudio. History or presence of other concomitant liver diseases including: Hepatitis C virus infection b.
Active hepatitis B infection; however, subjects who have seroconverted hepatitis B surface antigen and hepatitis B e antigen negative may be included in this study after consultation with the medical monitor c. Primary antimirocondriales cholangitis d. Alcoholic liver disease e. Definite autoimmune anticuegpos disease anticuerops overlap hepatitis f. Presence of clinical complications of PBC or clinically significant hepatic anticuepros, including: Subjects who are placed on a transplant list despite a relatively early disease stage for example per regional guidelines may be eligible as long as they do not meet any of the other exclusion criteria b.
Cirrhosis with complications, including history within the past 12 months or presence of: Spontaneous bacterial peritonitis c. Known or suspected hepatocellular carcinoma d. Prior transjugular intrahepatic portosystemic shunt procedure e. Subjects who have undergone gastric bypass procedures gastric lap band is acceptable or ileal resection or plan to undergo either of these procedures 5. Other medical conditions that may diminish life expectancy, including known cancers except carcinomas in situ or other stable, relatively benign conditions such as chronic lymphatic leukemia 6.
Known history of human immunodeficiency virus infection 8.
ANTICUERPOS ANTIMITOCONDRIALES PDF
Medical conditions that may cause nonhepatic increases in ALP eg, Paget’s disease or fractures within 3 months antimitocondrialrs. Other clinically significant medical conditions that are not well controlled or for which medication needs are anticipated to change during the study History of alcohol abuse or other substance abuse within 1 year prior to Day 0 Participation in another investigational product, biologic, or medical device study within 30 days prior to Screening.
Participation in anticuer;os previous study of OCA is allowed with 3 months washout prior to enrollment in this study Mental instability or incompetence, such that the validity of informed consent or ability to antimitoconxriales compliant with the study is uncertain History of known or suspected clinically significant hypersensitivity to OCA or any of its components.
Ascitis no controlada iii. Sospecha o certeza de carcinoma hepatocelular. The primary efficacy endpoint will be the time to first antimitocondrialee of one of the following post randomization: Spontaneous bacterial peritonitis confirmed by diagnostic paracentesis e. Uncontrolled ascites diuretic resistant ascites requiring therapeutic paracentesis at a frequency of at least.
ANTICUERPOS ANTIMITOCONDRIALES PDF DOWNLOAD
Key Secondary Efficacy Analyses The key secondary efficacy endpoints are as follows: Time to first occurrence of MELD score? Time to liver transplant or death all-cause c. Change from Baseline in total bilirubin at end of study d.
Each component of the primary efficacy endpoint except MELD score? Liver-related death or liver transplant e. Liver-related death, liver transplant, or MELD score? Health outcomes and pharmacokinetic analyses.
Cambios en la bilirrubina total desde el valor de referencia al finalizar el estudio d. Cambios en la FA desde el valor antimitocondriale referencia al finalizar el estudio.
The trial involves single site in the Member State concerned. Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the antimitocondriiales. Plans for treatment or care after the subject has ended the participation in the trial if it is different from the expected normal treatment of that condition.
Patients will revert to standard of care treatment.