CholangitisNCT02917408
Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
An observational study of Cholangitis and Liver Cirrhosis, Biliary, run by Xiaoli Fan at 1 site in China.
Trial summary
Retrospective study of all patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records. The following variables will be retrospectively studied: age, sex, first symptoms, clinical characteristics, pathology, treatment, stage, complications of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangitis, Liver Cirrhosis, Biliary, Cholestasis
- How many people
- 769 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records.
Who may be able to join
- Newly diagnosis of PBC at West China Hospital during January 2001 to July 2016.
Who cannot join
- Simultaneously diagnosed of autoimmune hepatitis or primary sclerosing cholangitis.
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective study of all patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records. The following variables will be retrospectively studied: age, sex, first symptoms, clinical characteristics, pathology, treatment, stage, complications of cirrhosis, other autoimmune diseases and long-term outcome.
- Conditions
- Cholangitis, Liver Cirrhosis, Biliary, Cholestasis, Liver Diseases, Liver Cirrhosis, Bile Duct Diseases
- Medical subject headings
- Cholangitis, Liver Cirrhosis, Biliary, Cholestasis, Liver Diseases, Liver Cirrhosis, Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary biliary cholangitis during January 2001 to July 2016 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of demographics, management patterns (clinical and diagnostic), comorbidities of PBC patients at diagnosis during the past 16 years.
Measured: Up to 16 years.
Secondary outcomes (1)
Evaluation of adverse outcome free survival of the PBC cohort during the 16 years.
Measured: Up to 16 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 769 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaoli Fan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoli Fan, West China Hospital
- Investigators
- Li Yang, MD, Study chair, West China Hospital,Chengdu, Sichuan, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917408
- Sponsor's protocol ID
- PBC-1
- Status last verified
- Nov 2020
- First submitted
- 6 Sep 2016
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
- ClinicalTrials.gov ID
- NCT02917408
- Acronym / sponsor ID
- PBC-1
- Conditions
- Cholangitis, Liver Cirrhosis, Biliary, Cholestasis, Liver Diseases, Liver Cirrhosis, Bile Duct Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 769 participants (actual)
- Lead sponsor
- Xiaoli FanUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 28 Sep 2016 (estimated)
- 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.
Retrospective study of all patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records. The following variables will be retrospectively studied: age, sex, first symptoms, clinical characteristics, pathology, treatment, stage, complications of cirrhosis, other autoimmune diseases and long-term outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary biliary cholangitis during January 2001 to July 2016 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records.
Key inclusion criteria (1 listed)
- Newly diagnosis of PBC at West China Hospital during January 2001 to July 2016.
Key exclusion criteria (1 listed)
- Simultaneously diagnosed of autoimmune hepatitis or 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, management patterns (clinical and diagnostic), comorbidities of PBC patients at diagnosis during the past 16 years.
Time frame: Up to 16 years.
1 secondary outcome
Evaluation of adverse outcome free survival of the PBC cohort during the 16 years.
Time frame: Up to 16 years.
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 10 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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,Chengdu, Sichuan, China
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 Cholangitis and Liver Cirrhosis, Biliary, run by Xiaoli Fan 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 10 Nov 2020. 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, management patterns (clinical and diagnostic), comorbidities of PBC patients at diagnosis during the past 16 years. (time frame: Up to 16 years.). 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 10 Nov 2020.