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3 Study Matches

Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients

Lipodystrophies are rare disorders characterized by selective loss of adipose tissue and predisposition to insulin resistance and its metabolic complications. Hepatic steatosis is a common complication in patients with partial and generalized lipodystrophies.Despite aggressive management of diabetes and hyperlipidemia, hepatic steatosis and its complications present a therapeutic challenge in many patients. Due to this large disease burden, it is important to assess the efficacy and safety of novel therapies for hepatic steatosis in patients with lipodystrophies.There are, however, no systematic studies evaluating various therapeutic interventions for reducing hepatic steatosis in patients with lipodystrophies. A variety of drugs have been investigated in nonlipodystrophic patients with non-alcoholic hepatic steatosis and steatohepatitis (NASH) or non-alcoholic fatty liver disease (NAFLD). Recent data support the activation of the farnesoid X receptor (FXR, NR1H4), a nuclear hormone receptor regulated by bile acids, for treatment of NASH and NAFLD. FXR activates transcription of several genes particularly the atypical nuclear receptor small heterodimer partner (SHP, NR0B2) and thus can influence triglyceride metabolism within hepatocytes.Both cholic acid (CA) and chenodeoxycholic acid (CDCA) are ligands for FXR, however, UDCA which is the 7 hydroxy β-epimer of CDCA, does not activate FXR. Obeticholic acid (OCA) is a first-in-class selective FXR agonist which has approximately 100 fold greater FXR-agonistic activity in the nanomolar range, as compared to CDCA .It therefore appears that FXR modulation offers interesting therapeutic possibilities in treating hepatic steatosis. This study is primarily designed to study efficacy of OCA, a strong FXR ligand, in reducing hepatic triglyceride levels in patients with hepatic steatosis and Familial Partial Lipodystrophy (FPLD). If proven to be effective, it may reduce morbidity and mortality as a result of sequelae of hepatic steatosis in patients with lipodystrophies.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Abhimanyu Garg
12461
All
18 Years to 70 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02430077
STU 062014-033
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Inclusion Criteria:
1. Patients with familial partial lipodystrophy of the Dunnigan variety with heterozygous disease-causing missense mutation in lamin A/C (LMNA) gene. 2. Hepatic steatosis (>5.6% hepatic triglyceride content) as demonstrated by 1H magnetic resonance spectroscopy. 3. Age 18-70 years. 4. Alcohol intake of less than 20 g per day in females and 30 g per day in males. 5. Participants and their partners with whom they are having sex, must use medically-acceptable birth control (contraceptives) during the study. Medically-acceptable methods of contraception include: (1) surgical sterilization, such as hysterectomy, tubal ligation or vasectomy. (2) approved hormonal contraceptives, such as birth control pills, patch or ring; Depo-Provera, Implanon. (3) barrier methods, such as condom, cervical cap or diaphragm used with a spermicide. (4) an intrauterine device (IUD).
Exclusion Criteria:
1. Laboratory or other histologic findings highly suggestive of liver disease due to causes other than non-alcoholic steatohepatitis, such as chronic viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, biliary obstruction or genetic liver diseases such as Wilson's disease, hemochromatosis or alpha-1-antitrypsin deficiency. 2. Treatment with drugs associated with steatohepatitis, e.g., corticosteroids, high dose estrogens, methotrexate, amiodarone, tamoxifen, valproic acid, sulfasalazine, or oxacillin for more than 2 weeks in the 6 months prior to the study. 3. Decompensated liver disease as evidenced by clinical features of hepatic failure (variceal bleeding, ascites, hepatic encephalopathy etc.) and laboratory investigations (prolonged prothrombin time with INR > 1.3, hypoalbuminemia with serum albumin less than 3.0 g/dL, direct bilirubin > 1.3 mg/dL, or presence of esophageal varices etc.) 4. Evidence of hepatocellular carcinoma: alpha-fetoprotein levels greater than 200 ng/ml and/or liver mass on imaging study suggestive of liver cancer. 5. Use of drugs which can potentially decrease hepatic steatosis during previous 3 months; ursodeoxycholic acid, thiazolidinediones, high-dose vitamin E, betaine, acetylcysteine and choline. 6. Significant systemic or major illnesses other than liver disease, such as congestive heart failure, cerebrovascular disease, respiratory failure, renal failure (serum creatinine >2 mg/dL), acute pancreatitis, organ transplantation, serious psychiatric disease, and malignancy, that could interfere with the trial and adequate follow up. 7. Acute medical illnesses precluding participation in the studies. 8. Known HIV-infected patient. 9. Current substance abuse. 10. Pregnant or lactating woman. 11. Hematocrit of less than 30%. 12. History of weight loss during past 3 months. 13. Patients on bile acid binding resins, cholestyramine, colestipol or colesevelam. 14. Hypersensitivity or intolerance to OCA or any components of its formulation. 15. Failure to give informed consent 16 .Previous clinical diagnosis of diabetes mellitus or fasting blood glucose ≥ 126 mg/dL or hemoglobin A1c ≥ 6.5%.
Drug: Obeticholic Acid, Drug: Placebo
Familial Partial Lipodystrophy, Liver
Hepatic Steatosis
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Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis (AlcHepNet)

This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases. The primary objective of the study is to determine the clinical efficacy and safety of Anakinra (plus zinc) compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH. Key secondary objectives broadly are as follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment response; and (b) to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Mack Mitchell
124226
All
21 Years to 65 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04072822
STU-2019-1368
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Inclusion Criteria 1. AH, as defined by the NIAAA pan-consortia for AH6: 1. Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks to screening visit 2. Regular consumption of alcohol with an intake of > 40 gm daily or >280gm weekly on average for women and > 60 gm daily or >420gm weekly on average for men for 6 months or more, with less than 8 weeks of abstinence before onset of jaundice 3. AST > 50 IU/l 4. AST:ALT > 1.5 and both values < 400 IU/l 5. and/or histological evidence of AH* 2. MELD 20-35 on day of randomization.
• In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST < 50 IU/L or > 400 IU/L, AST/ALT ratio < 1.5), antinuclear antibody > 1:160 or SMA > 1:80, a standard of care liver biopsy may be performed during current hospital admission to confirm AH and exclude competing etiologies 17 Exclusion Criteria 1. MELD SCORE <20 or > 35 2. Active sepsis (positive blood or ascitic cultures) with Systemic Inflammatory Response Syndrome (SIRS) or hemodynamic compromise requiring intravenous pressors to maintain tissue perfusion 3. Pneumonia as evidenced by radiological exam 4. Multi-organ failure 5. Renal failure defined by GFR <50 mL/min. 6. Clinically active C. diff infection 7. History of imaging of the liver (ultrasound, computerized tomography or magnetic resonance) showing other causes of jaundice 8. History of other liver diseases including hepatitis B (positive HBsAg or HBV DNA), hepatitis C (positive HCV RNA), autoimmune hepatitis, Wilson disease, genetic \hemochromatosis, alpha1-antitrypsin deficiency or strong suspicion of Drug Induced Liver Injury (DILI) 9. History of HIV infection (positive HIV RNA or on treatment for HIV infection) 10. History or presence of cancer (including hepatocellular carcinoma) other than non- melanoma skin cancer 11. History of other significant medical problems such as autoimmune diseases, severe asthma, psoriasis, Inflammatory Bowel Disease (IBD), etc. that might require immunosuppressive treatments 12. Pregnancy or breastfeeding 13. Prior exposure to experimental therapies in last 3 months 14. Prior exposure to systemic corticosteroid (glucocorticoid) or immunosuppressive therapy for more than 4 days within previous 30 days 15. Need for inotropic pressor support to maintain perfusion to critical organs within prior 48 hours before randomization and initiation of experimental treatment 16. Clinically significant pancreatitis- abdominal pain, elevated lipase (> 3 X ULN) and at least edema of pancreas with fat-stranding on CT scan 17. Total WBC count > 30,000/mm3 18. Known allergy or intolerance to therapeutic agents to be tested 19. Inability to voluntarily obtain informed consent from participant or guardian 20. Perceived inability to follow study procedures and comply with protocol 21. Platelet count < 50,000 k/cumm. 22. Positive PCR test for COVID -19 within 7 days prior to the baseline day 0 visit *Positive test is exclusionary only during screening period. If a patient tests positive any time after baseline randomization, a positive PCR test for COVID-19 will be considered as a SAE.
Drug: Anakinra and Zinc, Drug: Prednisone, Drug: Placebos
Alcoholic Hepatitis, Liver
UT Southwestern; Parkland Health & Hospital System
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Alcoholic Hepatitis Network Observational Study

The purpose of this research study is to create a clinical database and bio-repository. To do this, we will obtain blood, urine, and stool samples (e.g., biological samples) and personal health information from you to use in future research studies related to alcoholic hepatitis or other diseases. Part of your blood sample will be used to extract your DNA. DNA is the genetic material that gives us unique characteristics. We are doing this research study because we are trying to find out more about how and why illnesses related to alcoholic hepatitis or other diseases occur in people. To do this, we will study the biological samples and personal health information from healthy and sick people. A "biological sample" is usually blood, but can be any body fluid. "Personal Health Information" includes such items as your name, age, gender, race, and/or your medical information. It can also include data from measurements and tests that you had while participating in another research study or that were done during the course of your regular medical care or doctor visits.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Mack Mitchell
124226
All
21 Years and over
This study is also accepting healthy volunteers
NCT03850899
STU-2019-0472
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CASES: Heavy drinkers with alcoholic hepatitis Inclusion criteria 1. A clinical diagnosis of alcoholic hepatitis 2. Serum total bilirubin >3 mg/dL 3. Subject or guardian ability to understand and willingness to provide written consent 4. Age greater or equal to 21 years 5. Re-enrolment of an alcoholic hepatitis donor is permissible up to 4 times if the donor presents with a new episode of alcoholic hepatitis 24 weeks or longer after the most recent enrolment in the study Exclusion criteria 1. Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis 2. (NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation.)Pregnant or breast feeding Based on the judgment of the investigator, subject is not capable of understanding or complying with the study requirements. CONTROLS: Heavy drinkers without significant liver disease Inclusion criteria 1. History of chronic alcohol consumption sufficient to cause liver damage. Generally, this is considered to be >40 g/day or >280g/week on average for women and >60 g/day or >420 g/week on average for men, for many years (usually decades). Judgement about chronic alcohol consumption will be made by the site investigator. 2. Subject or guardian ability to understand and willingness to provide written consent 3. Age greater or equal to 21 years Exclusion criteria 1. Past evidence of alcoholic liver disease, defined as a bilirubin > 2.0 mg/dL, an AST > 1.5 ULN, and any hospital admission for liver disease, or the presence of esophageal varices or ascites (at any time in the past). 2. Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis (NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation.) 3. Alcohol intake at less than 40 g/day or 280g/week on average for women and 60 g/day or 420 g/week on average for men for longer than the past 28 days 4. If liver stiffness has been assessed within the prior 90 days, then stiffness suggesting fibrosis of F1 or greater is excluded. For Fibroscan, this is a fibrosis score >7.0 kPa. 5. Pregnant or breast feeding 6. Any of the following laboratory abnormalities within 90 days prior to signing the consent. 1. Total bilirubin: >ULN* 2. INR: > 1.4 5 *Individuals with a diagnosis of Gilbert's can have total bilirubin up to 3.0 mg/dL and still be eligible for participation. Healthy Controls Inclusion criteria 1. AUDIT-C scores of <4 for men and <3 for women (signifying no alcohol misuse) 2. Abstinent (consumption of less than one standard drink/week) during the 6 months prior to enrolment 3. Ability to understand and willingness to provide written consent. Exclusion criteria 1. Clinical history or laboratory evidence of liver disease including alcoholic liver disease, NAFLD, hemochromatosis, alcoholic hepatitis, autoimmune liver disease, Wilson disease, hepatitis C, or hepatitis B. 2. Presence of diabetes (requiring treatment with oral agents or insulin). 3. Significant heart disease (prior history of heart disease, other than hypertension) 4. Chronic lung disease (requiring chronic treatment) 5. Immune related conditions (such as Crohn's disease, rheumatoid arthritis, ulcerative colitis, systemic lupus erythematosus, severe psoriasis, etc.) 6. Known infection with HIV 7. Presumed infection, or use of antibiotics or other medications (e.g., corticosteroids) that would affect immune function, within the past 14 days 8. BMI>35 9. Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment 10. Pregnant or breast feeding 11. Any of the following laboratory abnormalities within 90 days prior to signing the consent. 1. Hemoglobin: <10 g/dL 2. Conjugated bilirubin: > ULN 3. INR: > 1.4 4. AST: >40 IU/mL 5. ALT: >40 IU/mL 12. Based on the judgment of the investigator, subject is not capable of complying with the study requirements
Alcoholic Hepatitis, Liver
UT Southwestern; Parkland Health & Hospital System
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