Chronic Liver DiseasePhase 4URSO-003NCT05849558
Study to Compare the Efficacy & Safety of Ursoplus Capsules vs. UDCA vs. Placebo Among Chronic Liver Disease Patients
A Phase 4 study testing Ursoplus and UDCA 250mg in people with Chronic Liver Disease, run by MinaPharm Pharmaceuticals at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- Ursoplus and UDCA 250mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 297 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2022to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Air Force Specialized Hospital
Cairo, New Cairo
About this study
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
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
Read the 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
- Conditions
- Chronic Liver Disease
- Being tested
- Ursoplus, UDCA 250mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrsoplusDrug
Ursoplus® capsules (UDCA 250mg \& Silymarin 140mg)
UDCA 250mgDrug
UDCA 250mg alone
PlaceboOther
Placebo alone
| Study group | Role | What they receive |
|---|---|---|
| Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) | Experimental | Ursoplus® capsules: UDCA 250mg \& Silymarin 140mg
2 Capsules every 12 hours Receives: Drug: Ursoplus |
| UDCA 250mg | Active comparator | UDCA capsules: UDCA 250mg
2 Capsules every 12 hours Receives: Drug: UDCA 250mg |
| Placebo | Placebo comparator | Placebo alone
2 Capsules every 12 hours Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total serum bilirubin
Change in mean Total serum bilirubin from baseline (visit 1) to End of study between the 3 treatment groups
Measured: 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
Measured: 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
Measured: Up to 6 months
Secondary outcomes (3)
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
Measured: Up to 6 months
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).
Measured: Up to 6 months
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start22 Feb 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 297 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MinaPharm Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gamal Dr Esmat, PhD, Principal investigator, Air Force Specialized HospitalMohamed El Kassas, PhD, Principal investigator, Helwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849558
- Sponsor's protocol ID
- URSO - 003
- Acronym
- URSO-003
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05849558
- Acronym / sponsor ID
- URSO-003 / URSO - 003
- Conditions
- Chronic Liver Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 297 participants (estimated)
- Lead sponsor
- MinaPharm PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Group 1: with non-cirrhosis, F0, F1 and F2 Group 2: with advanced fibrosis and cirrhosis, F3 and F4
| Arm | Type | Receives |
|---|---|---|
| Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) | Experimental | Drug: UrsoplusUrsoplus® capsules: UDCA 250mg \& Silymarin 140mg 2 Capsules every 12 hours |
| UDCA 250mg | Active comparator | Drug: UDCA 250mgUDCA capsules: UDCA 250mg 2 Capsules every 12 hours |
| Placebo | Placebo comparator | Other: PlaceboPlacebo alone 2 Capsules every 12 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UrsoplusUrsoplus® capsules (UDCA 250mg \& Silymarin 140mg) | Drug | Ursoplus® capsules (UDCA 250mg & Silymarin 140mg) |
| UDCA 250mgUDCA 250mg alone | Drug | UDCA 250mg |
| PlaceboPlacebo alone | Other | Placebo |
Primary outcome
Change in Total serum bilirubin
Time frame: Up to 6 months
Change in mean Total serum bilirubin from baseline (visit 1) to End of study between the 3 treatment groups
Change in Direct Serum Bilirubin
Time frame: Up to 6 months
Change in mean Direct Serum Bilirubin from baseline (visit 1) to End of study between the 3 treatment groups
Change in Elevated Liver Enzymes
Time frame: Up to 6 months
Change in mean AST \& ALT from baseline (visit 1) to End of study between the 3 treatment groups
3 secondary outcomes
Improved degree of Steatosis
Time frame: Up to 6 months
Improved quality of life
Time frame: Up to 6 months
Incidence of adverse events (AEs)
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamal Dr Esmat, PhD principal investigator
Air Force Specialized Hospital
Mohamed El Kassas, PhD principal investigator
Helwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ursoplus and UDCA 250mg in people with Chronic Liver Disease, run by MinaPharm Pharmaceuticals at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gamal Dr Esmat, PhD (+202 01222455468, g_esmat@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total serum bilirubin (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.