Serum Levels of ALAT TransaminasesPhase 2URSONASHNCT00470171
Pilot Study of Ursodesoxycholic Acid in Non-Alcoholic Steatohepatitis
A Phase 2 study testing Ursodesoxycholic acid in people with Serum Levels of ALAT Transaminases and Serum Markers for Fibrosis and Hepatic Inflammation, run by Axcan Pharma at 1 site in France.
Trial summary
This is a phase II study with direct individual benefit. It is a randomized, double blind placebo controlled study whose aim is to evaluate the efficacy and tolerance of ursodesoxycholic acid in patients who have been diagnosed with non-alcoholic steatohepatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serum Levels of ALAT Transaminases, Serum Markers for Fibrosis and Hepatic Inflammation
- What is being tested?
- Ursodesoxycholic acid
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2005to Nov 2008
- Phase
- Phase 2
- 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
- Greater than 18 years of age.
- Hepatic biopsy consistent with non-alcoholic steatohepatitis: presence of >20% steatosis associated with hepatocyte swelling and/or intralobular necrosis within the last 18 months.
- Serum levels of ALAT and/or ASAT > 50 UI/L at the time of screening (with at least 3 elevated transaminase values within the last 12 months).
Who cannot join
- Hepatic biopsy not performed within the last 18 months.
- A single normal transaminase value within the last 12 months.
- Treatment with ursodesoxycholic acid within the last 12 months.
- Loss of more than 15% body weight between the time of the liver biopsy and the time of screening.
- Alcohol consumption of >20 g/day for women and > 30 g/day for men
- Hepatitis from other causes: chronic viral hepatitis B or C, elevated ferritin levels associated with C282Y homozygosity, primary biliary cirrhosis, primary sclerosing cholangitis, well documented auto-immune hepatitis (specific autoantibodies, hypergammaglobulinemia, consistent histologic changes), alpha1 antitrypsin deficiency, Wilson's disease, HIV infection.
Show all 12Show fewer
- NASH from secondary causes: long term amiodarone administration, corticosteroid therapy, anti-obesity surgery within the last 2 years, tamoxifen.
- Child's type B or C cirrhosis.
- Presence of hepatocellular carcinoma.
- Treatment with rosiglitazone or pioglitazone currently or during the 3 preceding years, treatment with Vitamin E within the 6 months prior to screening.
- Women who are pregnant or nursing.
- Unavailability of hepatic biopsy slides for centralized interpretation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Ursodesoxycholic Acid in the Management of Non-Alcoholic Steatohepatitis
This is a phase II study with direct individual benefit. It is a randomized, double blind placebo controlled study whose aim is to evaluate the efficacy and tolerance of ursodesoxycholic acid in patients who have been diagnosed with non-alcoholic steatohepatitis.
The hepatoprotective effects of ursodesoxycholic acid may ameliorate the hepatic impairment associated with non-alcoholic steatohepatitis leading to subsequent significant decreases in transaminase elevations and non-invasive markers for hepatic fibrosis A positive response is defined as a significantly larger decrease in average ALAT levels between the time of inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as compared to the placebo group.
The duration of the study will be 12 months. An end of treatment evaluation (EoT) will take place at the end of the 12th month of treatment.
- Being tested
- Ursodesoxycholic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodesoxycholic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
A positive response is defined as a significantly larger decrease in average ALAT levels between the time of inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as compared to the placebo group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startOct 2005
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serum Levels of ALAT TransaminasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axcan Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Vlad Ratziu, M.D., Ph.D., Principal investigator, La Pitié Salpétrière Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470171
- Sponsor's protocol ID
- URSONASH05-01
- Other IDs
- EudraCT n° : 2005-001931-31
- Acronym
- URSONASH
- Status last verified
- Feb 2009
- First submitted
- 4 May 2007
- Last updated
- 3 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ursodesoxycholic Acid in the Management of Non-Alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT00470171
- Acronym / sponsor ID
- URSONASH / URSONASH05-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Axcan PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 7 May 2007 (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 is a phase II study with direct individual benefit. It is a randomized, double blind placebo controlled study whose aim is to evaluate the efficacy and tolerance of ursodesoxycholic acid in patients who have been diagnosed with non-alcoholic steatohepatitis.
The hepatoprotective effects of ursodesoxycholic acid may ameliorate the hepatic impairment associated with non-alcoholic steatohepatitis leading to subsequent significant decreases in transaminase elevations and non-invasive markers for hepatic fibrosis A positive response is defined as a significantly larger decrease in average ALAT levels between the time of inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as compared to the placebo group.
The duration of the study will be 12 months. An end of treatment evaluation (EoT) will take place at the end of the 12th month of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than 18 years of age.
- Hepatic biopsy consistent with non-alcoholic steatohepatitis: presence of >20% steatosis associated with hepatocyte swelling and/or intralobular necrosis within the last 18 months.
- Serum levels of ALAT and/or ASAT > 50 UI/L at the time of screening (with at least 3 elevated transaminase values within the last 12 months).
Key exclusion criteria (12 listed)
- Hepatic biopsy not performed within the last 18 months.
- A single normal transaminase value within the last 12 months.
- Treatment with ursodesoxycholic acid within the last 12 months.
- Loss of more than 15% body weight between the time of the liver biopsy and the time of screening.
- Alcohol consumption of >20 g/day for women and > 30 g/day for men
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 |
|---|---|---|
| Ursodesoxycholic acid | Drug | – |
Primary outcome
A positive response is defined as a significantly larger decrease in average ALAT levels between the time of inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as compared to the placebo group.
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 3 Feb 2009.
Related trials for Serum Levels of ALAT Transaminases
Not yet recruitingPhase 2
Betaine vs. Placebo for Serologically Diagnosed Metabolic Dysfunction-associated Steatohepatitis (MASH)
MASH - Metabolic Dysfunction-Associated Steatohepatitis
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.
Vlad Ratziu, M.D., Ph.D. principal investigator
La Pitié Salpétrière Hospital, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ursodesoxycholic acid in people with Serum Levels of ALAT Transaminases and Serum Markers for Fibrosis and Hepatic Inflammation, run by Axcan Pharma at 1 site in France.
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 3 inclusion and 12 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 3 Feb 2009. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
A positive response is defined as a significantly larger decrease in average ALAT levels between the time of inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as compared to the placebo group.. 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 Feb 2009.