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Clinical Trial Details

Trial ID: L5981
Source ID: NCT03291249
Associated Drug: Foralumab
Title: Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With NASH and T2DM
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: NASH - Nonalcoholic Steatohepatitis|NAFLD|T2DM (Type 2 Diabetes Mellitus)
Interventions: DRUG: Foralumab|OTHER: placebo|DRUG: Omeprazole 20mg
Outcome Measures: Primary: severity and duration for all adverse events, Incidence, severity, and duration for all adverse events (AEs), and abnormal laboratory and physical findings up until 30 days after last dose, 30 days after last dose|Abnormal laboratory findings, Incidence, severity, and duration for all adverse events (AEs), and abnormal laboratory and physical findings up until 30 days after last dose, 30 days after last dose|Abnormal physical findings, Incidence, severity, and duration for all adverse events (AEs), and abnormal laboratory and physical findings up until 30 days after last dose, 30 days after last dose | Secondary: Change ALT levels, Day 30 versus Day 1 serum ALT levels, Day 30 versus Day 1 serum ALT levels|Change in HbA1c levels, HbA1c levels, Day 30 versus Day 1|change in HOMA/HOMA-IR scores, Day 30 versus Day 1 change in HOMA/HOMA-IR scores. Insulin and fasting plasma glucose will be measured to calculate HOMA/HOMA-IR, Day 30 versus Day 1 | Other: Body mass index (BMI), Measurment of BMI (kg/m\^2) Serum lipid profile: total cholesterol, triglycerides, low density lipoprotein (LDL) and high density lipoprotein (HDL) fractions., Day 1 versus day 30 and 60|Change in Immunological markers, C-reactive protein (CRP) b. T cell-associated cytokine levels (IL2, 4, 5, 6, 8,10,12, 13, IFN, TNF, TGF c. Regulatory T cell (Tregs) levels (cells positive for: CD4, CD25, CD8, CD56, CD3, CD62, CD127, NKT, FoxP3, LAP), Day 1 versus day 30 and 60|Cytokine levels, Measurement of Cytokine levels Mean serum concentrations of, cytokeratin (CK)-18 fragments, C-peptide, glucagon-like peptide-1 (GLP-1), adiponectin c. 13C-Methacetin breath test (MBT) Hepatic steatosis and fibrosis, Day 1 versus day 30 and 60|waist circumference, measurement of waist circumference (cm), Day 1 versus day 30 and 60|Serum lipid profile, Serum lipid concentration will be measured, Day 1 versus day 30 and 60|Regulatory T cell, Measurement of Regulatory T cell, Day 1 versus day 30 and 60|Liver enzymes, Measurement of Liver enzymes, Day 1 versus day 30 and 60|Mean serum concentrations of cytokeratin (CK)-18 fragments, Measurement of (CK)-18 fragments concentration, Day 1 versus day 30 and 60|Mean serum concentrations of C-peptide, Measurement of C-peptide concentration, Day 1 versus day 30 and 60|Mean serum concentrations of glucagon-like peptide-1 (GLP-1), Measurement of glucagon-like peptide-1 (GLP-1) concentration, Day 1 versus day 30 and 60|Mean serum concentrations of adiponectin, Measurement of adiponectin concentration, Day 1 versus day 30 and 60
Sponsor/Collaborators: Sponsor: Tiziana Life Sciences LTD
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-12-01
Completion Date: 2019-06-01
Results First Posted:
Last Update Posted: 2019-09-12
Locations:
URL: https://clinicaltrials.gov/show/NCT03291249