Primary Biliary CholangitisPhase 4NCT03345589
A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
A Phase 4 study testing 18-22mg/kg/d Ursodeoxycholic and 13-15mg/kg/d Ursodeoxycholic in people with Primary Biliary Cholangitis, run by West China Hospital at 1 site in China.
Trial summary
This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- 18-22mg/kg/d Ursodeoxycholic and 13-15mg/kg/d Ursodeoxycholic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2018to 1 Jan 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with primary biliary cholangitis
- Treated with Ursodeoxycholic Acid in West China Hospital for at least 6 month and suboptimal response to Ursodeoxycholic Acid
Who cannot join
- Autoimmune hepatitis
- Primary sclerosing cholangitis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Li Yang, +8618980601276, yangli_hx@scu.edu.cn
About this study
Official title: A Randomized Controlled Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis
- Conditions
- Primary Biliary Cholangitis
- Being tested
- 18-22mg/kg/d Ursodeoxycholic, 13-15mg/kg/d Ursodeoxycholic
- Keywords
- Ursodeoxycholic Acid
- 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.
18-22mg/kg/d UrsodeoxycholicDrug
18-22mg/kg/d Ursodeoxycholic
13-15mg/kg/d UrsodeoxycholicDrug
13-15mg/kg/d Ursodeoxycholic
| Study group | Role | What they receive |
|---|---|---|
| 18-22mg/kg/d Ursodeoxycholic group | Experimental | Not described Receives: Drug: 18-22mg/kg/d Ursodeoxycholic |
| 13-15mg/kg/d Ursodeoxycholic group | Placebo comparator | Not described Receives: Drug: 13-15mg/kg/d Ursodeoxycholic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC)
Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) in two arms.
Measured: Month 6 during treatment with 13-15mg/kg/d ursodeoxycholic acid or 18-22mg/kg/d ursodeoxycholic acid
Secondary outcomes (5)
Alkaline phosphatase
(ALP)
Measured: Week 2 and Month 1, 3, 6,9,12
Glutamyltransferase
(GGT)
Measured: Week 2 and Month 1, 3, 6,9,12
Alanine transaminase
(ALT)
Measured: Week 2 and Month 1, 3, 6
Aspartate transaminase
(AST)
Measured: Week 2 and Month 1, 3, 6, 9,12
Total bilirubin
(TB)
Measured: Week 2 and Month 1, 3, 6, 9,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start30 Jan 2018
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Yang, West China Hospital
- Investigators
- Li Yang, MD, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345589
- Sponsor's protocol ID
- PBC-3
- Status last verified
- May 2018
- First submitted
- 6 Nov 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
- ClinicalTrials.gov ID
- NCT03345589
- Acronym / sponsor ID
- PBC-3
- Conditions
- Primary Biliary Cholangitis
- Keywords
- Ursodeoxycholic Acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 17 Nov 2017 (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 evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18-22mg/kg/d Ursodeoxycholic group | Experimental | Drug: 18-22mg/kg/d Ursodeoxycholic |
| 13-15mg/kg/d Ursodeoxycholic group | Placebo comparator | Drug: 13-15mg/kg/d Ursodeoxycholic |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with primary biliary cholangitis
- Treated with Ursodeoxycholic Acid in West China Hospital for at least 6 month and suboptimal response to Ursodeoxycholic Acid
Key exclusion criteria (2 listed)
- Autoimmune hepatitis
- Primary sclerosing cholangitis
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 |
|---|---|---|
| 18-22mg/kg/d Ursodeoxycholic18-22mg/kg/d Ursodeoxycholic | Drug | 18-22mg/kg/d Ursodeoxycholic group |
| 13-15mg/kg/d Ursodeoxycholic13-15mg/kg/d Ursodeoxycholic | Drug | 13-15mg/kg/d Ursodeoxycholic group |
Primary outcome
Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC)
Time frame: Month 6 during treatment with 13-15mg/kg/d ursodeoxycholic acid or 18-22mg/kg/d ursodeoxycholic acid
Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) in two arms.
5 secondary outcomes
Alkaline phosphatase
Time frame: Week 2 and Month 1, 3, 6,9,12
Glutamyltransferase
Time frame: Week 2 and Month 1, 3, 6,9,12
Alanine transaminase
Time frame: Week 2 and Month 1, 3, 6
Aspartate transaminase
Time frame: Week 2 and Month 1, 3, 6, 9,12
Total bilirubin
Time frame: Week 2 and Month 1, 3, 6, 9,12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
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FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
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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.
Li Yang, MD study chair
West China 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 18-22mg/kg/d Ursodeoxycholic and 13-15mg/kg/d Ursodeoxycholic in people with Primary Biliary Cholangitis, run by West China Hospital at 1 site in China.
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 2 inclusion and 2 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 3 May 2018. 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 China. 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 Ping Ni, MD (13281091993, 545043216@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) (time frame: Month 6 during treatment with 13-15mg/kg/d ursodeoxycholic acid or 18-22mg/kg/d ursodeoxycholic acid). 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 3 May 2018.