Study to Compare the Efficacy & Safety of Ursoplus Capsules vs. UDCA vs. Placebo Among Chronic Liver Disease Patients - Clinical Trial for Chronic Liver Disease | NCT05849558

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Primary Purpose

Status

Recruiting

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Ursoplus

UDCA 250mg

Placebo

About this trial

This is an interventional treatment trial for Chronic Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Use of oral contraceptives in child bearing ladies

Sites / Locations

Air Force Specialized HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

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

UDCA 250mg

Placebo

Arm Description

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

UDCA capsules: UDCA 250mg 2 Capsules every 12 hours

Placebo alone 2 Capsules every 12 hours

Outcomes

Primary Outcome Measures

Change in Total serum bilirubin

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

Change in Direct Serum Bilirubin

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

Change in Elevated Liver Enzymes

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

Secondary Outcome Measures

Improved degree of Steatosis

Change in the mean score of Controlled Attenuation Parameter (CAP) from baseline (visit 1) to End of study between the 3 treatment groups, measured by Vibration-controlled transient elastography

Improved quality of life

Change in the mean Score of different items of the RAND 36-Item Health Survey between the 3 treatment groups after 3 months (visit 4) and 6 months of treatment (End of study visit).

Incidence of adverse events (AEs)

Percent of serious (SAEs)/ non-serious adverse events (AEs), including percent changes in lab tests and percent of AEs leading to permanent discontinuation of the study drug.

Full Information

NCT ID

NCT05849558

First Posted

April 12, 2023

Last Updated

April 27, 2023

Sponsor

MinaPharm Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05849558

Brief Title

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

Acronym

URSO-003

Official Title

Multi-Center, Randomized, Control, Phase IV Trial to Compare the Efficacy & Safety of Ursoplus® Capsules (UDCA 250mg & Silymarin 140mg) Versus UDCA Alone Versus Placebo Among Compensated Chronic Liver Diseased Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 22, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MinaPharm Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

Research Question: Compare the efficacy & safety of Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) versus UDCA alone versus Placebo among Compensated chronic liver diseased patients Primary Objective: To assess the efficacy of Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) versus UDCA 250mg alone and versus Placebo in the reduction of total serum bilirubin, Direct serum bilirubin and elevated liver Enzymes from baseline to End of Treatment (EOT) Secondary Objectives: To assess the efficacy of Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) versus UDCA 250 mg alone and versus Placebo in reducing the degree of steatosis as measured by Vibration-controlled transient elastography with Controlled Attenuation Parameter (CAP) To assess the safety of Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) versus UDCA 250 mg alone and versus Placebo among compensated Chronic Liver Diseased Patients To describe improvement in quality of life for patients after treatment A study population of 297 patients suffering from compensated chronic Liver Disease, who will be randomized according to Vibration-controlled transient elastography in screening visit into 2 groups: Group 1: with non-cirrhosis, F0, F1 and F2. Group 2: with advanced fibrosis and cirrhosis, F3 and F4. Each group will receive either Ursoplus® capsules (UDCA 250mg & Silymarin 140mg), or UDCA alone or Placebo, through Stratified random sampling. Duration for enrollment: 6 months Total duration of the study/subject will be approximately: 6 months for treatment and follow-up visits including the screening visit Subjects will be enrolled for a duration of 6 months including the screening visit Screening visit 1 (Treatment initiation) Visit 2: after 1st month, follow-up 1 Visit 3: after 2nd month, follow-up 2 Visit 4: after 3rd month, follow-up 3 Visit 5: after 4th month, follow-up 4 Visit 6: after 5th month, follow-up 5 End of Study visit, after 6th month of treatment, follow-up 6

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Liver Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

297 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

UDCA 250mg

Arm Type

Active Comparator

Arm Description

UDCA capsules: UDCA 250mg 2 Capsules every 12 hours

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo alone 2 Capsules every 12 hours

Intervention Type

Drug

Intervention Name(s)

Ursoplus

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

UDCA 250mg

Intervention Description

UDCA 250mg alone

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo alone

Primary Outcome Measure Information:

Title

Change in Total serum bilirubin

Description

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

Time Frame

Up to 6 months

Title

Change in Direct Serum Bilirubin

Description

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

Time Frame

Up to 6 months

Title

Change in Elevated Liver Enzymes

Description

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

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

Improved degree of Steatosis

Description

Change in the mean score of Controlled Attenuation Parameter (CAP) from baseline (visit 1) to End of study between the 3 treatment groups, measured by Vibration-controlled transient elastography

Time Frame

Up to 6 months

Title

Improved quality of life

Description

Change in the mean Score of different items of the RAND 36-Item Health Survey between the 3 treatment groups after 3 months (visit 4) and 6 months of treatment (End of study visit).

Time Frame

Up to 6 months

Title

Incidence of adverse events (AEs)

Description

Percent of serious (SAEs)/ non-serious adverse events (AEs), including percent changes in lab tests and percent of AEs leading to permanent discontinuation of the study drug.

Time Frame

Up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Use of oral contraceptives in child bearing ladies

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gamal Dr Esmat, PhD

Phone

+202 01222455468

Email

g_esmat@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed Dr El Kassas, PhD

Phone

+2 01114455552-

Email

m_elkassas@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gamal Dr Esmat, PhD

Organizational Affiliation

Air Force Specialized Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohamed El Kassas, PhD

Organizational Affiliation

Helwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Air Force Specialized Hospital

City

Cairo

State/Province

New Cairo

Country

Egypt

Individual Site Status

Recruiting

Study to Compare the Efficacy & Safety of Ursoplus Capsules vs. UDCA vs. Placebo Among Chronic Liver Disease Patients (URSO-003)

Chronic Liver Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial