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Study Matches
A Phase 2b Study in Subjects With AlcoholicHepatitisto Evaluate Safety and Efficacy of DUR-928 Treatment (AHFIRM)
This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating
Safety and Efficacy of DUR-928 (an experimental medication) in Patients with AlcoholicHepatitis (AH).
1. Able to provide written informed consent (either from subject or subject's legally
acceptable representative).
2. Onset of jaundice within prior 8 weeks.
3. Average daily consumption of >40 (females) or >60 (males) grams of alcohol for 6
months or longer, with < 8 weeks of abstinence before the onset of jaundice.
4. The determination of AH may be based on typical serum chemistry (as determined by
local laboratory) or liver biopsy at any time during the current episode of AH:
• Serum total bilirubin > 3.0 mg/dL
• 50 < AST < 400 IU/L
• ALT < 400 IU/L
• AST/ALT > 1.5
5. Maddrey discriminant function (MDF) ≥ 32 assuming a control prothrombin time of 12
seconds.
6. Model for End-stage Liver Disease (MELD) score: 21-30.
7. Liver biopsy is not required, but may be used to confirm the diagnosis of AH at the
Investigator's discretion. Biopsy, if used as a diagnostic criterion, must have
occurred during the current episode.
8. Male or female subjects 18 years of age or older.
9. Subjects must agree to use effective methods to prevent pregnancy while participating
in the study.
10. Subjects must agree to participate in an alcohol abstinence support program
recommended by the local institution's addiction specialists.
Exclusion Criteria:
1. Subjects taking systemic corticosteroids for a duration exceeding 8 days in the 30
days prior to screening.
2. Subjects experiencing or considered at high risk for alcohol withdrawal seizures or
delirium tremens.
3. Active infection (such as spontaneous bacterial peritonitis [SBP], urinary tract
infection [UTI], bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS
CoV2 infection).
4. Serum creatinine >2.5 mg/dL.
5. Subjects undergoing continuous veno-venous hemodialysis (CVVH).
6. Uncontrolled gastrointestinal bleeding.
7. A history of pre-admission refractory ascites defined as more than 4 paracenteses in
the previous 8 weeks despite diuretic therapy.
8. Liver biopsy (if carried out) with findings not compatible with AH.
9. Stage ≥3 hepatic encephalopathy by West Haven criteria.
10. Any severe concomitant cardiovascular, renal, endocrine, pulmonary, psychiatric
disorder, or multi-organ failure.
11. Other concomitant cause(s) of liver disease.
12. Any active malignancy or any malignancy diagnosed within the last five years other
than curable skin cancer (basal cell or squamous cell carcinomas).
13. Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and
opiates) except THC and prescription medications.
14. Existing or intended pregnancy or breast feeding.
15. Participation in another interventional clinical trial within 30 days of Screening.
16. History of organ transplantation, other than a corneal transplant.
17. Underlying diseases that, in the opinion of the site investigator, might be
complicated or exacerbated by proposed treatments or might confound assessment of
study drug.
Drug: DUR-928 30 mg, Drug: DUR-928 90 mg, Drug: Placebo+ Standard of Care (SOC)
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.
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
AlcoholicHepatitis, Liver
UT Southwestern; Parkland Health & Hospital System