Non Alcoholic SteatohepatitisPhase 2FLIRTNCT00492700
A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis
A Phase 2 study testing rosiglitazone in people with Non Alcoholic Steatohepatitis, run by Association pour la Recherche sur les Maladies Hépatiques Virales at 1 site in France.
Trial summary
This study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Alcoholic Steatohepatitis
- What is being tested?
- rosiglitazone
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2003to not given
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven NASH with steatosis >= 20%
- Increased serum ALT
Who cannot join
- bland steatosis
- daily alcohol > 20/30 g (women/men)
- any other cause of liver disease
- secondary NASH including drug-induced steatohepatitis
- treatment with insulin or glitazones
- cardiac insufficiency
- Hb < 10 g/dl
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'hépatogastroenérologie, Hôpital Pitié Salpêtrière
Paris, 75013
About this study
This study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).
Read the detailed description
Phase one : A double blind randomized placebo controlled trial of rosiglitazone
- 64 pts with biopsy proven NASH will be randomized to receive either rosiglitazone 8 mg/day or placebo for one year.
- after one year of treatment patients will undergo a liver biopsy then a 4 month follow off treatment
Primary endpoint: improvement of at least 30% of the histological score of steatosis Secondary endpoints: improvement in ALT values, in necrosis and inflammation and fibrosis
Phase II extension open label trial
All participants to the phase one regardless of the drug received in the first year will be treated with rosiglitazone for 2 additional years. A liver biopsy will be performed at the end of these two additional years in order to find out whether prolonged rosiglitazone therapy further results in improvement of liver injury in NASH patients.
- Conditions
- Non Alcoholic Steatohepatitis
- Being tested
- rosiglitazone
- Keywords
- steatosis,, fibrosis,, diabetes,, obesity
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Fibrosis, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in steatosis
Secondary outcomes (1)
improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Alcoholic SteatohepatitisStudies 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour la Recherche sur les Maladies Hépatiques Virales
- Sponsor type
- University, hospital or other
- Investigators
- Vlad Ratziu, MD PhD, Principal investigator, Hôpital Pitié Salpêtrière, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492700
- Sponsor's protocol ID
- LIDO-Trials-01
- Acronym
- FLIRT
- Status last verified
- Jun 2007
- First submitted
- 26 Jun 2007
- Last updated
- 27 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Ratziu V, Charlotte F, Bernhardt C, Giral P, Halbron M, Lenaour G, Hartmann-Heurtier A, Bruckert E, Poynard T; LIDO Study Group. Long-term efficacy of rosiglitazone in nonalcoholic steatohepatitis: results of the fatty liver improvement by rosiglitazone therapy (FLIRT 2) extension trial. Hepatology. 2010 Feb;51(2):445-53. doi: 10.1002/hep.23270.
PubMed 19877169
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT00492700
- Acronym / sponsor ID
- FLIRT / LIDO-Trials-01
- Conditions
- Non Alcoholic Steatohepatitis
- Keywords
- steatosis,, fibrosis,, diabetes,, obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Association pour la Recherche sur les Maladies Hépatiques ViralesUniversity, hospital or other
- Study start
- Jan 2003
- First posted
- 27 Jun 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 study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).
Detailed description
Phase one : A double blind randomized placebo controlled trial of rosiglitazone
- 64 pts with biopsy proven NASH will be randomized to receive either rosiglitazone 8 mg/day or placebo for one year.
- after one year of treatment patients will undergo a liver biopsy then a 4 month follow off treatment
Primary endpoint: improvement of at least 30% of the histological score of steatosis Secondary endpoints: improvement in ALT values, in necrosis and inflammation and fibrosis
Phase II extension open label trial
All participants to the phase one regardless of the drug received in the first year will be treated with rosiglitazone for 2 additional years. A liver biopsy will be performed at the end of these two additional years in order to find out whether prolonged rosiglitazone therapy further results in improvement of liver injury in NASH patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically proven NASH with steatosis >= 20%
- Increased serum ALT
Key exclusion criteria (7 listed)
- bland steatosis
- daily alcohol > 20/30 g (women/men)
- any other cause of liver disease
- secondary NASH including drug-induced steatohepatitis
- treatment with insulin or glitazones
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 |
|---|---|---|
| rosiglitazone | Drug | – |
Primary outcome
improvement in steatosis
1 secondary outcome
improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis
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 27 Jun 2007.
- Derived from this study: PubMed 19877169Ratziu V, Charlotte F, Bernhardt C, Giral P, Halbron M, Lenaour G, Hartmann-Heurtier A, Bruckert E, Poynard T; LIDO Study Group. Long-term efficacy of rosiglitazone in nonalcoholic steatohepatitis: results of the fatty liver improvement by rosiglitazone therapy (FLIRT 2) extension trial. Hepatology. 2010 Feb;51(2):445-53. doi: 10.1002/hep.23270.
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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.
Vlad Ratziu, MD PhD principal investigator
Hôpital Pitié Salpêtrière, APHP
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 rosiglitazone in people with Non Alcoholic Steatohepatitis, run by Association pour la Recherche sur les Maladies Hépatiques Virales 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 2 inclusion and 7 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 27 Jun 2007. 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?
improvement in steatosis. 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 NCT00492700, which also lists 1 linked publication.
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 27 Jun 2007.