Primary Biliary CirrhosisPhase 3NCT04751188
A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis
A Phase 3 study testing Bezafibrate 200 MG Oral Tablet and Ursodeoxycholic Acid in people with Primary Biliary Cirrhosis, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Biliary Cirrhosis
- What is being tested?
- Bezafibrate 200 MG Oral Tablet and Ursodeoxycholic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteMexico
- Study dates
- 2 Oct 2020to Jul 2021
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PBC diagnosis (consistent with American Association for the Study of Liver Disease [AASLD]:
- History of elevated alkaline phosphatase levels.
- Anti-mitochondrial antibodies positivity
- Histopathologic evidence of nonsuppurative cholangitis and destruction of small or medium- sized bile ducts.
- Use of ursodeoxycholic acid (UDCA) for at least 12 months at enrollment at a therapeutic dose (13 to 15 mg per Kg per day).
- Evidence of a suboptimal biochemical response to UDCA, defined by the presence of one of the Paris II criteria.
- Written informed consent.
- Age ≥ 18 years.
Who cannot join
- Hepatic decompensation (ascitis, variceal upper gastrointestinal bleeding, hepatic encephalopathy).
- Coexistence autoimmune hepatitis.
- Bilirrubin >3mg/dl.
- For females, pregnancy or breast-feeding.
- Hepatocellular carcinoma.
- History or presence of spontaneous bacterial peritonitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Bezafibrate Plus Ursodesoxicolic Acid in Patients With Primary Biliary Cholangitis Without Response
Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation.
The main objective of the study is to evaluate safety and efficacy of bezafibrate plus ursodesoxicolic acid in patients with PBC and inadequate response to UDCA.
- Conditions
- Primary Biliary Cirrhosis
- Being tested
- Bezafibrate 200 MG Oral Tablet, Placebo, Ursodeoxycholic Acid
- Keywords
- ursodeoxycholic acid, Bezafibrate
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bezafibrate 200 MG Oral TabletDrug
Bezafibrate one tablet every 12 hours for six months.
PlaceboDrug
Placebo one tablet every 12 hours for six months.
Ursodeoxycholic AcidDrug
At a dose of 13 to 15 mg per Kg per day.
| Study group | Role | What they receive |
|---|---|---|
| Bezafibrate and Ursodeoxycholic acid | Experimental | Bezafibrate 200 mg every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months. Receives: Drug: Bezafibrate 200 MG Oral Tablet; Drug: Ursodeoxycholic Acid |
| Placebo and Ursodeoxycholic acid | Placebo comparator | Placebo tablet every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months. Receives: Drug: Placebo; Drug: Ursodeoxycholic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical response
Biochemical response is defined as the reduction of alkaline phosphatase lower than 1.5 times the upper normal limit, reduction of aspartate transaminase lower than 1.5 times the upper normal limit and bilirubin lower than 1 mg/dl.
Measured: 6 months
Secondary outcomes (2)
Quality of life
Evaluation of quality of life with the Primary Biliary Cholangitis 40 questionnaire
Measured: Baseline and 6 months later
Pruritus intensity
Evaluation made by the use of visual analogue scales.
Measured: Baseline and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start2 Oct 2020
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CirrhosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jocelyn Serrano Casas, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751188
- Sponsor's protocol ID
- R-2020-2101-031
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Bezafibrate Plus Ursodesoxicolic Acid in Patients With Primary Biliary Cholangitis Without Response
- ClinicalTrials.gov ID
- NCT04751188
- Acronym / sponsor ID
- R-2020-2101-031
- Conditions
- Primary Biliary Cirrhosis
- Keywords
- ursodeoxycholic acid, Bezafibrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 12 Feb 2021 (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.
Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation.
The main objective of the study is to evaluate safety and efficacy of bezafibrate plus ursodesoxicolic acid in patients with PBC and inadequate response to UDCA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bezafibrate and Ursodeoxycholic acid | Experimental | Drug: Bezafibrate 200 MG Oral Tablet, Drug: Ursodeoxycholic AcidBezafibrate 200 mg every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months. |
| Placebo and Ursodeoxycholic acid | Placebo comparator | Drug: Placebo, Drug: Ursodeoxycholic AcidPlacebo tablet every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- PBC diagnosis (consistent with American Association for the Study of Liver Disease [AASLD]:
- Use of ursodeoxycholic acid (UDCA) for at least 12 months at enrollment at a therapeutic dose (13 to 15 mg per Kg per day).
- Evidence of a suboptimal biochemical response to UDCA, defined by the presence of one of the Paris II criteria.
- Written informed consent.
- Age ≥ 18 years.
Key exclusion criteria (6 listed)
- Hepatic decompensation (ascitis, variceal upper gastrointestinal bleeding, hepatic encephalopathy).
- Coexistence autoimmune hepatitis.
- Bilirrubin >3mg/dl.
- For females, pregnancy or breast-feeding.
- Hepatocellular carcinoma.
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 |
|---|---|---|
| Bezafibrate 200 MG Oral TabletBezafibrate one tablet every 12 hours for six months. | Drug | Bezafibrate and Ursodeoxycholic acid |
| PlaceboPlacebo one tablet every 12 hours for six months. | Drug | Placebo and Ursodeoxycholic acid |
| Ursodeoxycholic AcidAt a dose of 13 to 15 mg per Kg per day. | Drug | Bezafibrate and Ursodeoxycholic acid, Placebo and Ursodeoxycholic acid |
Primary outcome
Biochemical response
Time frame: 6 months
Biochemical response is defined as the reduction of alkaline phosphatase lower than 1.5 times the upper normal limit, reduction of aspartate transaminase lower than 1.5 times the upper normal limit and bilirubin lower than 1 mg/dl.
2 secondary outcomes
Quality of life
Time frame: Baseline and 6 months later
Pruritus intensity
Time frame: Baseline and 6 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bezafibrate 200 MG Oral Tablet and Ursodeoxycholic Acid in people with Primary Biliary Cirrhosis, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 8 inclusion and 6 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 12 Feb 2021. 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 Mexico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical response (time frame: 6 months). 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 12 Feb 2021.