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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. Hepaticsteatosis is a
common complication in patients with partial and generalized lipodystrophies.Despite
aggressive management of diabetes and hyperlipidemia, hepaticsteatosis 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 hepaticsteatosis in
patients with lipodystrophies.There are, however, no systematic studies evaluating various
therapeutic interventions for reducing hepaticsteatosis in patients with lipodystrophies. A
variety of drugs have been investigated in nonlipodystrophic patients with non-alcoholichepaticsteatosis and steatohepatitis (NASH) or non-alcoholic fatty liverdisease (NAFLD).
Recent data support the activation of the farnesoid X receptor (FXR, NR1H4), a nuclear
hormone receptor regulated by bileacids, 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 hepaticsteatosis. This
study is primarily designed to study efficacy of OCA, a strong FXR ligand, in reducing
hepatictriglyceride levels in patients with hepaticsteatosis and Familial Partial
Lipodystrophy (FPLD). If proven to be effective, it may reduce morbidity and mortality as a
result of sequelae of hepaticsteatosis 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%.
Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe AlcoholicHepatitis (AlcHepNet)
This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on
novel treatments for severe alcoholichepatitis (AH), a life-threatening stage of alcoholicliverinjury that has a short-term mortality rate much higher than that of other liverdiseases.
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
Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once
daily versus placebo in subjects with non-alcoholic steatohepatitis
Call 214-648-5005 studyfinder@utsouthwestern.edu
William Lee
14217
All
18 Years to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02970942
STU-2019-0799
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Inclusion Criteria:
• Informed consent obtained before any trial-related activities. Trial-related
activities are any procedures that are carried out as part of the trial, including
activities to determine suitability for the trial except for protocol described
pre-screening activities which require a separate informed consent.
• Male or female, aged 18-75 years (both inclusive) (for Japan: male or female aged
20-75 years (both inclusive)) at the time of signing informed consent
• Local histological diagnosis of NASH followed by histological confirmation of NASH
based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks
before screening
• Histologic evidence of NASH based on central pathologist evaluation of a liver biopsy
obtained up to 21 weeks before screening.
• NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based
on central pathologist evaluation
Exclusion Criteria:
• Known or suspected abuse of alcohol (above 20 g/day for women or above 30 g/day for
men), alcohol dependence* or narcotics. (* = assessed by the Alcohol Use Disorders
Identification Test (AUDIT questionnaire))
• Diagnosis of type 1 diabetes according to medical records
• HbA1c above 10% at screening
• History or presence of pancreatitis (acute or chronic)
• Calcitonin equal or above 50 ng/L at screening
• Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid
carcinoma. Family is defined as a first degree relative
• Body Mass Index (BMI) ≤ 25.0 kg/sqm at the screening visit (visit 1)
• Female who is pregnant, breast-feeding or intends to become pregnant or is of
childbearing potential and not using an adequate contraceptive method (adequate
contraceptive measures as required by local regulation or practice)
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 alcoholichepatitisor 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 alcoholichepatitisor 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
Novel Therapies in Moderately Severe Acute AlcoholicHepatitis (NTAH-Mod)
This study is being done to find out whether a diet supplemented with a probiotic nutrient
can improve alcoholichepatitisand gut complications compared to routine standard care.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Mack Mitchell
124226
All
21 Years to 70 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01922895
STU 092012-012
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Inclusion Criteria:
1. Ability to provide informed consent by subject or appropriate family member
2. Age between 21-70 years
3. Recent alcohol consumption > 50 g/d for > 6 months, continuing within two months
before enrollment
4. At least 2 of the following symptoms or signs of acute alcoholic hepatitis: Anorexia,
nausea, RUQ pain, jaundice, leukocytosis, hepatomegaly AND
5. Elevation of AST > 80 U/L, but < 500 U/L at the time of admission or within 3 days of
baseline visit; AST > ALT and ALT < 200 U/L; total bilirubin > 3 mg/dL AND
6. Liver biopsy showing alcoholic hepatitis (steatohepatitis) OR ultrasound of liver
showing increased echogenicity OR CT scan showing decreased attenuation of liver
compared to spleen OR MRI showing fatty liver (decreased signaling intensity on T1
weighted images). If the liver biopsy (done within 60 days of inclusion) confirms
diagnosis of AAH then inclusion e will be waived.
7. Model for End-Stage Liver Disease (MELD) <20
8. Willingness to utilize two reliable forms of contraception (both males and females of
childbearing potential) from screening through the first six weeks of study.
Exclusion Criteria:
1. Hypotension with BP < 80/50 after volume repletion
2. Pregnancy; incarceration; inability to provide consent or lack of appropriate family
member
3. Signs of systemic infection: Fever > 38o C and positive blood or ascites cultures on
appropriate antibiotic therapy for > 3 days within 3 days of inclusion
4. Acute gastrointestinal bleeding requiring > 2 units blood transfusion within the
previous 4 days
5. Undue risk from immunosuppression: Positive HBsAg; a positive skin PPD skin test or
history of treatment for tuberculosis; history of any malignancy including
hepatocellular carcinoma; known HIV infection
6. Treatment with corticosteroids or other immunosuppressive medications including
specific anti-TNF therapy (not including pentoxifylline), calcineurin inhibitors for >
3 days within the previous 3 months.
7. Evidence of acute pancreatitis: CT evidence and/or amylase or lipase > 5 X upper limit
of normal
8. Serious cardiac, respiratory or neurologic disease or evidence of autoimmune
hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilsons disease,
hemochromatosis, secondary iron overload due to chronic hemolysis, alpha-1-antitrypsin
deficiency
9. Acute or chronic kidney injury with serum creatinine > 3.0 mg/dl
Dietary Supplement: Lactobacillus Rhamnosus GG, Drug: Placebo for Probiotic
Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute AlcoholicHepatitis
This study will compare two different treatments of acute alcoholichepatitis. The current
standard of care is treatment with corticosteroids (methylprednisolone). This will be
compared to treatment with anakinra, pentoxifylline, plus zinc sulfate. The participants will
be treated and followed for 6 months and the two treatment groups will be compared for
differences in death rates and laboratory tests that measure liverand gut function.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Mack Mitchell
124226
All
21 Years to 70 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT01809132
STU 082012-007
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Inclusion Criteria:
1. Ability to provide informed consent by subject or appropriate family member
2. Age between 21-70 years
3. Recent alcohol consumption > 50 g/d for > 6 months, continuing within two months
before enrollment
4. d. At least 2 of the following symptoms of acute alcoholic hepatitis: Anorexia,
nausea, RUQ pain
5. Liver biopsy showing alcoholic hepatitis (steatohepatitis) OR ultrasound of liver
showing increased echogenicity OR CT scan showing decreased attenuation of liver
compared to spleen OR MRI showing fatty liver (decreased signaling intensity on T1
weighted images) If liver biopsy confirms diagnosis of alcoholic hepatitis then
requirement for AST elevation > 50 is waived. The liver biopsy must be done within 60
days of study enrollment.
6. AST levels:
• AST> Or equal to 50 IU/mL but less than 500 IU/mL
• AST> ALT, ratio AST/ALT> 1.5; ALT < 200 IU/mL
• or biopsy proven alcoholic hepatitis.
7. Model for End-Stage Liver Disease (MELD) ≥ 20 and Maddrey DF ≥ 32.
8. Willingness to utilize two reliable forms of contraception (both males and females of
childbearing potential) from screening through the first 6 weeks of the study.
Exclusion Criteria:
1. Hypotension with BP < 80/50 after volume repletion
2. Pregnancy; incarceration; inability to provide consent or lack of appropriate family
member
3. Signs of uncontrolled systemic infection: Fever > 38°C and positive blood or ascites
cultures and on appropriate antibiotic therapy for ≥ 3 days within 3 days of inclusion
4. Acute gastrointestinal bleeding requiring >2 units blood transfusion within the
previous 4 days
5. Undue risk from immunosuppression: Positive HBsAg; a positive skin PPD skin test, a
positive quantiferon, or history of treatment for tuberculosis; history of any
malignancy except skin cancer but including hepatocellular carcinoma within the last
five years; HIV infection
6. Recent previous treatment with corticosteroids or other immunosuppressive medications
including specific anti-TNF therapy (not including pentoxifylline), calcineurin
inhibitors within the previous 3 months. Treatment with corticosteroids for ≤3 days
prior to baseline is acceptable.
7. Evidence of acute pancreatitis: CT evidence or amylase or lipase > 5 X upper limit of
normal (ULN).
8. Serious cardiac, respiratory or neurologic disease or evidence of other liver diseases
such as autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing
cholangitis, Wilson disease, hemochromatosis, secondary iron overload due to chronic
hemolysis, alpha-1-antitrypsin deficiency
9. Acute or chronic kidney injury with serum creatinine > 3.0 mg/dl.