EUCTR2020-004534-38-FR
Active, not recruiting
Phase 1
A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in subjects with Alcoholic Hepatitis
ConditionsAlcoholic hepatitisMedDRA version: 20.0Level: LLTClassification code 10001624Term: Alcoholic hepatitisSystem Organ Class: 100000004871Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsMethylprednisolone
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Alcoholic hepatitis
- Sponsor
- DURECT Corporation
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 alcohol for 6 months or longer, with \< 8 weeks of abstinence before the onset of jaundice. Judgment regarding daily and long\-term alcohol use and onset of jaundice will be made by the site investigator.
- •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
- •NOTE: Labs values on the day of randomization must include serum total bilirubin \> 3\.0 mg/dL and AST and ALT \< 400 IU/L in addition to the MDF and MELD values in inclusion 5 and 6 below.
- •5\. Maddrey discriminant function (MDF) \= 32 assuming a control prothrombin time of 12 seconds NOTE: If a local laboratory’s control time differs from 12 seconds then the local laboratory’s control time should be used.
Exclusion Criteria
- •1\. Subjects taking systemic corticosteroids for a duration exceeding 8 days in the 30 days prior to screening. NOTE: Inhaled, topical, or local corticosteroid injections are permitted
- •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).
- •a. Subjects who are febrile with leukocytosis are also excluded until active infection has been excluded to the satisfaction of the PI in consultation with the medical monitor.
- •b. Patients with bacterial peritonitis may be considered for enrollment once the infection has been treated and follow up paracentesis confirms the absence of SBP.
- •c. Patients with fungal infection of any kind cannot be considered for this trial.
- •4\. Serum creatinine \>2\.5 mg/dL
- •5\. Criterion removed as part of Protocol Amendment 2, but placeholder kept to maintain consistency in subsequent criteria numbering
- •6\. Subjects undergoing continuous veno\-venous hemodialysis (CVVH)
- •7\. Uncontrolled gastrointestinal bleeding
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 TreatmentAlcoholic hepatitisMedDRA version: 20.0Level: LLTClassification code 10001624Term: Alcoholic hepatitisSystem Organ Class: 100000004871Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]EUCTR2020-004534-38-DEDURECT Corporation300
Active, not recruiting
Not Applicable
A Clinical Trial Investigating OSI-906 in Patients with Adrenocortical CarcinomaAdrenocortical CarcinomaMedDRA version: 14.1Level: PTClassification code 10001388Term: Adrenocortical carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2009-012820-97-DEAstellas Pharma Global Development, Inc.135
Recruiting
Phase 3
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast CancerBreast cancerBreast carcinoma10006291NL-OMON51870Merck Sharp & Dohme (MSD)24
Active, not recruiting
Not Applicable
A study of AMG 416 in the treatment of secondary hyperparathyroidism in chronic kidney diseaseSecondary hyperparathyroidism in subjects with chronic kidney diseaseMedDRA version: 17.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disordersMedDRA version: 17.0Level: LLTClassification code 10020706Term: Hyperparathyroidism NOSSystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]EUCTR2012-002805-23-ATKAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)500
Active, not recruiting
Phase 1
A phase 3 randomised, double-blind, placebo-controlled efficacy and safety study funded by Furiex Pharmaceuticals. The purpose of this study is to find out if a new investigational drug called JNJ-27018966 is safe and effective as a treatment for diarrhea-predominant Irritable Bowel Syndrome (IBS-d).Diarrhea-predominant irritable bowel syndromeMedDRA version: 20.1 Level: LLT Classification code 10060845 Term: Diarrhea predominant irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.1 Level: PT Classification code 10023003 Term: Irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]EUCTR2012-001600-38-GBFuriex Pharmaceuticals1,282