Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT05849558
Status:
UNKNOWN
Last Update Posted:
2023-05-09
First Post:
2023-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Compare the Efficacy & Safety of Ursoplus Capsules vs. UDCA vs. Placebo Among Chronic Liver Disease Patients
Sponsor:
MinaPharm Pharmaceuticals
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
URSO-003
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: