Nonalcoholic SteatohepatitisPhase 2NCT00699036
Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study testing avandia, metformin and losartan in people with Nonalcoholic Steatohepatitis and Nonalcoholic Fatty Liver Disease, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease
- What is being tested?
- avandia, metformin and losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Aug 2009
- 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
- Patients between 18-70 years old
- Negative urine pregnancy test in females
- History of elevated liver associated enzymes (ALT > 40)
- Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH
Who cannot join
- ALT greater than three times normal
- NYHA class 3 or 4 heart failure
- Any congestive heart failure patient on insulin
- Patients on one of the 3 study drugs within the past 3 months prior to enrollment
- Alcohol consumption >20 gm/day in a female and > 30 gm/day in a male
- Evidence of co-existent chronic liver disease to include viral hepatitis, Wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis
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- Serum creatinine on initial screening of greater than 1.4
- Known hypersensitivity to rosiglitazone, metformin, or losartan
- Known history of diabetic ketoacidosis
- Female that is breastfeeding
- Insulin dependent diabetic
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brooke Army Medical Center
San Antonio, Texas, 78234
Dawn M Torres, MD, 210-916-5649
Dawn M Torres, MD
About this study
Official title: Rosiglitazone Versus Rosiglitazone and Metformin (Avandamet) Versus Combination Rosiglitazone and Losartan in the Treatment of Nonalcoholic Steatohepatitis (NASH). A Prospective, Open-Label, Randomized Trial
The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?
- Keywords
- nonalcoholic steatohepatitis (NASH), fatty liver, insulin resistance
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
avandiaDrug
4 mg twice daily
metforminDrug
500 mg twice daily for 48 weeks
losartanDrug
losartan 50 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | avandia Receives: Drug: avandia |
| 2 | Experimental | avandia plus metformin Receives: Drug: avandia; Drug: metformin |
| 3 | Experimental | avandia plus losartan Receives: Drug: avandia; Drug: losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver biopsy histologic improvement
Measured: end of study
Secondary outcomes (1)
serum transaminases
Measured: throughout study (ongoing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startApr 2007
- Primary completionJul 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic 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
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Dawn M Torres, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699036
- Sponsor's protocol ID
- C.2007.066
- Status last verified
- Jun 2009
- First submitted
- 16 Jun 2008
- Last updated
- 19 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rosiglitazone Versus Rosiglitazone and Metformin (Avandamet) Versus Combination Rosiglitazone and Losartan in the Treatment of Nonalcoholic Steatohepatitis (NASH). A Prospective, Open-Label, Randomized Trial
- ClinicalTrials.gov ID
- NCT00699036
- Acronym / sponsor ID
- C.2007.066
- Keywords
- nonalcoholic steatohepatitis (NASH), fatty liver, insulin resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Apr 2007
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 17 Jun 2008 (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.
The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: avandiaavandia |
| 2 | Experimental | Drug: avandia, Drug: metforminavandia plus metformin |
| 3 | Experimental | Drug: avandia, Drug: losartanavandia plus losartan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between 18-70 years old
- Negative urine pregnancy test in females
- History of elevated liver associated enzymes (ALT > 40)
- Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH
Key exclusion criteria (11 listed)
- ALT greater than three times normal
- NYHA class 3 or 4 heart failure
- Any congestive heart failure patient on insulin
- Patients on one of the 3 study drugs within the past 3 months prior to enrollment
- Alcohol consumption >20 gm/day in a female and > 30 gm/day in a male
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 |
|---|---|---|
| avandia4 mg twice daily | Drug | 1, 2, 3 |
| metformin500 mg twice daily for 48 weeks | Drug | 2 |
| losartanlosartan 50 mg once daily | Drug | 3 |
Primary outcome
liver biopsy histologic improvement
Time frame: end of study
1 secondary outcome
serum transaminases
Time frame: throughout study (ongoing)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2009.
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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.
Dawn M Torres, MD principal investigator
Brooke Army Medical Center
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 avandia, metformin and losartan in people with Nonalcoholic Steatohepatitis and Nonalcoholic Fatty Liver Disease, run by Brooke Army Medical Center at 1 site in United States.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 Jun 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver biopsy histologic improvement (time frame: end of study). 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 19 Jun 2009.