Study to Compare the Efficacy & Safety of Ursoplus Capsules vs. UDCA vs. Placebo Among Chronic Liver Disease Patients

NCT05849558 | Unknown Phase 4 DMC

• 1 other identifier: URSO - 003
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy \& safety of Ursoplus® capsules (UDCA 250mg \& Silymarin 140mg) versus UDCA alone versus Placebo among Compensated Chronic Liver Diseased Patients

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (3)

• Change in Total serum bilirubin

  Change in mean Total serum bilirubin from baseline (visit 1) to End of study between the 3 treatment groups

  Up to 6 months

• Change in Direct Serum Bilirubin

  Change in mean Direct Serum Bilirubin from baseline (visit 1) to End of study between the 3 treatment groups

  Up to 6 months

• Change in Elevated Liver Enzymes

  Change in mean AST \& ALT from baseline (visit 1) to End of study between the 3 treatment groups

  Up to 6 months

Secondary Outcomes (3)

• Improved degree of Steatosis

  Up to 6 months

• Improved quality of life

  Up to 6 months

• Incidence of adverse events (AEs)

  Up to 6 months

Study Arms (3)

Ursoplus® capsules (UDCA 250mg & Silymarin 140mg)

EXPERIMENTAL

Ursoplus® capsules: UDCA 250mg \& Silymarin 140mg 2 Capsules every 12 hours

Drug: Ursoplus

UDCA 250mg

ACTIVE COMPARATOR

UDCA capsules: UDCA 250mg 2 Capsules every 12 hours

Drug: UDCA 250mg

Placebo

PLACEBO COMPARATOR

Placebo alone 2 Capsules every 12 hours

Other: Placebo

Interventions

Ursoplus DRUG

Ursoplus® capsules (UDCA 250mg \& Silymarin 140mg)

Ursoplus® capsules (UDCA 250mg & Silymarin 140mg)

UDCA 250mg DRUG

UDCA 250mg alone

UDCA 250mg

Placebo OTHER

Placebo alone

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged ≥ 18
• Subjects with Compensated Chronic Liver Disease, defined as child 5-7.
• Patients with mild disturbance of liver biochemical profile (elevated Total Serum Bilirubin ≤ 3 mg/dl, or elevated Direct Serum Bilirubin ≤ 2 mg/dl, or elevated one or more of liver enzymes, up to 3 times of the normal level (Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) \& Gamma Glutamyl Transpeptidase (GGT)).
• Non-diabetic subjects and subjects with Controlled DM-type 1 and 2 patients, HbA1C up to 7.5%
• Non-pregnant or lactating female patients
• Subjects who are willing to sign Informed Consent Form (ICF) and ready to comply with the protocol for the duration of the study

You may not qualify if:

• Subjects with a history of hypersensitivity to any of the ingredients of the medications being studied
• Subjects with positive PCR/or antibodies to Hepatitis C in the past 6 months
• Subjects with positive hepatitis B surface antigen (HBsAg)
• Subjects with elevated liver enzymes more than 3 times of the normal level Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) \& Gamma Glutamyl Transpeptidase (GGT).
• Subjects with Primary Biliary Cirrhosis (PBC) and Primary Sclerosing Cholangitis (PSC).
• Subjects with Child Pugh Score more than 7.
• Subjects with history of bleeding varices.
• Subjects having uncontrolled Diabetes (HbA1cmore than 7.5 %)
• Subjects with any medical condition requiring the usage of medication that may interfere with the absorption, distribution, metabolism or excretion of the study drug such as:
• Bile acid sequestering agents such as cholestyramine and colestipol.
• Antacids containing aluminum hydroxide.
• Drugs affecting lipid metabolism such as estrogens, oral and hormonal contraceptives, and clofibrate (and perhaps other lipid-lowering drugs)
• Subjects who are receiving other liver support drugs (including drugs of the study), 1 month before study initiation.
• Subjects with auto immune liver disease taking corticosteroid or immune suppressant
• Pregnant or breast-feeding women

Sponsors & Collaborators

• MinaPharm Pharmaceuticals: lead

Study Sites (1)

Air Force Specialized Hospital

Cairo, New Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Ursodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Gamal Dr Esmat, PhD

  Air Force Specialized Hospital

  PRINCIPAL INVESTIGATOR

• Mohamed El Kassas, PhD

  Helwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gamal Dr Esmat, PhD

CONTACT

+202 01222455468; g_esmat@yahoo.com

Mohamed Dr El Kassas, PhD

CONTACT

+2 01114455552-; m_elkassas@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Group 1: with non-cirrhosis, F0, F1 and F2 Group 2: with advanced fibrosis and cirrhosis, F3 and F4

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 9, 2023
• Study Start: February 22, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-04

Locations

EG (1)