Clinical Trials Logo

Clinical Trial Summary

We hypothesize that individuals with Alpha-1 Antitrypsin (AAT) deficiency have ongoing liver injury which is not detected by the usual blood tests used to look at liver function. This ongoing liver injury leads to cirrhosis in a significant number of adults with AAT deficiency.


Clinical Trial Description

Our overarching hypothesis is that liver disease in adults with AAT deficiency is the result of the accumulation of the abnormally folded protein within the endoplasmic reticulum of the hepatocyte. In some individuals, the intrinsic cellular mechanisms of the hepatocyte are sufficient to clear adequate amounts of the abnormally folded protein such that liver disease does not occur. In AAT deficient individuals who develop liver disease, environmental and other genetic factors stress the hepatocyte, and the normal cellular mechanisms that maintain homeostasis are disrupted, leading to liver disease. For this proposal, our hypothesis is that the prevalence of liver disease in adults with AAT is higher than previously reported because liver injury and fibrosis is not accurately detected by available routine liver testing. Testing this hypothesis will require an initial evaluation for liver disease with liver function testing and imaging, and then histologic confirmation by liver biopsy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01810458
Study type Observational
Source University of Florida
Contact
Status Completed
Phase
Start date October 2013
Completion date September 2019

See also
  Status Clinical Trial Phase
Recruiting NCT06308757 - Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis N/A
Recruiting NCT06051669 - Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US
Completed NCT06244550 - Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors N/A
Recruiting NCT06098417 - Biomarkers in the Diagnosis and Prognosis of NAFLD
Not yet recruiting NCT03623360 - Functional MRI to Determine Severity of Cirrhosis
Recruiting NCT01965418 - A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial Phase 4
Not yet recruiting NCT01133184 - Improved Prevention of Perinatal Hepatitis B Transmission Phase 4
Completed NCT00043303 - Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis Phase 2
Completed NCT03872024 - Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients N/A
Recruiting NCT05912179 - Prospective Single Centre Observational Study to Compare the Diagnostic Yield of Different Modalities of Liver Biopsy
Recruiting NCT04533828 - 68Ga-FAPI PET/CT in Liver Fibrosis Patients Early Phase 1
Completed NCT04573543 - The Role of Immune Semaphorins in NAFLD
Recruiting NCT03277651 - Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension N/A
Completed NCT01707472 - Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis Phase 2
Completed NCT01988753 - Non-invasive Biomarkers of Fibrosis in Pediatric Liver Diseases
Completed NCT01934777 - Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis Phase 3
Completed NCT02060162 - Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa
Completed NCT00049842 - Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED) Phase 3
Recruiting NCT06063785 - Multispectral Optoacoustic Tomography in Patients With Cystic Fibrosis
Recruiting NCT04669470 - Bariatric Endoscopy and NAFLD N/A