Primary Biliary CholangitisNCT03322943
The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital
An observational study of Primary Biliary Cholangitis, run by West China Hospital at 1 site in China.
Trial summary
This study evaluates the different response of Ursodeoxycholic Acid in primary biliary cholangitis only and primary biliary cholangitis with high immune globulin G or aminotransferase at West China Hospital from 2008-2017. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Primary Biliary Cholangitis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 30 Dec 2018
- Phase
- Observational
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with primary biliary cholangitis and treated with Ursodeoxycholic Acid at West China Hospital by review of medical records.
Who may be able to join
- Patients diagnosed with primary biliary cholangitis Treated with Ursodeoxycholic Acid in West China Hospital for at least 1 year
Who cannot join
- Autoimmune hepatitis Primary sclerosing cholangitis
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the different response of Ursodeoxycholic Acid in primary biliary cholangitis only and primary biliary cholangitis with high immune globulin G or aminotransferase at West China Hospital from 2008-2017.
- Conditions
- Primary Biliary Cholangitis
- Keywords
- Ursodeoxycholic Acid, Response
- Medical subject headings
- Liver Cirrhosis, Biliary
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of demographics, clinical index after treatment
age，sex，ALT（IU/L），AST（IU/L），ALP（IU/L），GGT（IU/L）,IgG（g/L）
Measured: up to 1 year
Secondary outcomes (1)
Evaluation whether the PBC patients have response after treatment
Use Paris II criterion to estimate
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start1 Jan 2016
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (actual)
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
- NCT03322943
- Sponsor's protocol ID
- PBC-2
- Status last verified
- Mar 2019
- First submitted
- 8 Oct 2017
- Last updated
- 13 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital
- ClinicalTrials.gov ID
- NCT03322943
- Acronym / sponsor ID
- PBC-2
- Conditions
- Primary Biliary Cholangitis
- Keywords
- Ursodeoxycholic Acid, Response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 26 Oct 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 different response of Ursodeoxycholic Acid in primary biliary cholangitis only and primary biliary cholangitis with high immune globulin G or aminotransferase at West China Hospital from 2008-2017.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with primary biliary cholangitis and treated with Ursodeoxycholic Acid at West China Hospital by review of medical records.
Key inclusion criteria (1 listed)
- Patients diagnosed with primary biliary cholangitis Treated with Ursodeoxycholic Acid in West China Hospital for at least 1 year
Key exclusion criteria (1 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.
Primary outcome
Description of demographics, clinical index after treatment
Time frame: up to 1 year
age，sex，ALT（IU/L），AST（IU/L），ALP（IU/L），GGT（IU/L）,IgG（g/L）
1 secondary outcome
Evaluation whether the PBC patients have response after treatment
Time frame: within 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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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?
An observational study of 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Mar 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Description of demographics, clinical index after treatment (time frame: up to 1 year). 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 13 Mar 2019.