Liver TransplantationNCT01073202
Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation
A study testing ursodeoxycholic acid in people with Liver Transplantation and Ischemia-reperfusion Injury, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study is designed to investigate the possible beneficial effects of UDCA on liver graft recovery early after adult liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Ischemia-reperfusion Injury, Cholestasis
- What is being tested?
- ursodeoxycholic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- May 2005to Jan 2009
- Phase
- Interventional
- 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
- All liver transplant patients in our center between May 2005 and April 2008 were potentially eligible for enrollment
Who cannot join
- Age less than 18 years
- Treatment with UDCA within one month before operation
- Inability to provide written informed consent prior to study entry
- Non-liver organ(s) failure prior to entry
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080
About this study
This study is designed to investigate the possible beneficial effects of UDCA on liver graft recovery early after adult liver transplantation.
- Being tested
- ursodeoxycholic acid, identical-appearing placebo
- Medical subject headings
- Reperfusion Injury, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ursodeoxycholic acidDrug
13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation
identical-appearing placeboDrug
13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| ursodeoxycholic acid | Active comparator | Not described Receives: Drug: ursodeoxycholic acid |
| identical-appearing placebo | Placebo comparator | Not described Receives: Drug: identical-appearing placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum liver tests
Serum liver tests include serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), alkaline phosphatase (ALP) and total bilirubin (TB)
Measured: within the first 4 weeks after liver transplantation
Secondary outcomes (1)
Postoperative complications
Postoperative complications include rates of acute cellular rejection (ACR), drug-induced hepatotoxicity, vascular or biliary complications, recurrence of primary liver disease and death
Measured: within the first 4 weeks after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startMay 2005
- Primary completionApr 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Zhi-Hai Peng, MD, Study chair, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073202
- Sponsor's protocol ID
- SFPH05B41
- Status last verified
- Dec 2009
- First submitted
- 22 Feb 2010
- Last updated
- 30 Dec 2010
- Results posted
- No
Publications
Hertl M, Hertl MC, Kluth D, Broelsch CE. Hydrophilic bile salts protect bile duct epithelium during cold preservation: a scanning electron microscopy study. Liver Transpl. 2000 Mar;6(2):207-12. doi: 10.1002/lt.500060201.
PubMed 10719022Hertl M, Hertl MC, Kunkel P, Schilling S, Prevot B, Kluth D, Malago M, Broelsch CE. Tauroursodeoxycholate ameliorates reperfusion injury after pig liver transplantation. Transpl Int. 1999;12(6):454-62. doi: 10.1007/s001470050257.
PubMed 10654358Hertl M, Harvey PR, Swanson PE, West DD, Howard TK, Shenoy S, Strasberg SM. Evidence of preservation injury to bile ducts by bile salts in the pig and its prevention by infusions of hydrophilic bile salts. Hepatology. 1995 Apr;21(4):1130-7.
PubMed 7705788
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation
- ClinicalTrials.gov ID
- NCT01073202
- Acronym / sponsor ID
- SFPH05B41
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 23 Feb 2010 (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.
This study is designed to investigate the possible beneficial effects of UDCA on liver graft recovery early after adult liver transplantation.
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 |
|---|---|---|
| ursodeoxycholic acid | Active comparator | Drug: ursodeoxycholic acid |
| identical-appearing placebo | Placebo comparator | Drug: identical-appearing placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All liver transplant patients in our center between May 2005 and April 2008 were potentially eligible for enrollment
Key exclusion criteria (4 listed)
- Age less than 18 years
- Treatment with UDCA within one month before operation
- Inability to provide written informed consent prior to study entry
- Non-liver organ(s) failure prior to entry
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 |
|---|---|---|
| ursodeoxycholic acid13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation | Drug | ursodeoxycholic acid |
| identical-appearing placebo13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation | Drug | identical-appearing placebo |
Primary outcome
Serum liver tests
Time frame: within the first 4 weeks after liver transplantation
Serum liver tests include serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), alkaline phosphatase (ALP) and total bilirubin (TB)
1 secondary outcome
Postoperative complications
Time frame: within the first 4 weeks after liver transplantation
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 30 Dec 2010.
- Background: PubMed 10719022Hertl M, Hertl MC, Kluth D, Broelsch CE. Hydrophilic bile salts protect bile duct epithelium during cold preservation: a scanning electron microscopy study. Liver Transpl. 2000 Mar;6(2):207-12. doi: 10.1002/lt.500060201.
- Background: PubMed 10654358Hertl M, Hertl MC, Kunkel P, Schilling S, Prevot B, Kluth D, Malago M, Broelsch CE. Tauroursodeoxycholate ameliorates reperfusion injury after pig liver transplantation. Transpl Int. 1999;12(6):454-62. doi: 10.1007/s001470050257.
- Background: PubMed 7705788Hertl M, Harvey PR, Swanson PE, West DD, Howard TK, Shenoy S, Strasberg SM. Evidence of preservation injury to bile ducts by bile salts in the pig and its prevention by infusions of hydrophilic bile salts. Hepatology. 1995 Apr;21(4):1130-7.
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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.
Zhi-Hai Peng, MD study chair
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ursodeoxycholic acid in people with Liver Transplantation and Ischemia-reperfusion Injury, run by Shanghai Jiao Tong University School of Medicine 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 4 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 30 Dec 2010. 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.
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?
Serum liver tests (time frame: within the first 4 weeks after liver transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01073202, which also lists 3 linked publications.
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 30 Dec 2010.