NASH (Non-alcoholic Steato-hepatitis)Phase 4NCT01406704
Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH
A Phase 4 study testing Rosiglitazone, alpha-lipoic acid and Rosiglitazone/alpha-lipoic acid in people with NASH (Non-alcoholic Steato-hepatitis), run by Seoul St. Mary's Hospital.
Trial summary
This study is to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic acid, antioxidant on patients with pathologically proved NASH (non-alcoholic steato-hepatitis). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- NASH (Non-alcoholic Steato-hepatitis)
- What is being tested?
- Rosiglitazone, alpha-lipoic acid and Rosiglitazone/alpha-lipoic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 2013
- Phase
- Phase 4
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patients with pathologically proved NASH (non-alcoholic steato-hepatitis)
Who cannot join
- alcohol consumption > 20g/day
- viral hepatitis B and C
- autoimmune hepatitis
- Wilson's disease
- hemochromatosis
- alpha-1 antitrypsin deficiency
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- breast-feeding or pregnant females
- subjects planning to become pregnant
- severe comorbid medical conditions (such as severe cardiac, pulmonary, renal or psychological problems)
- those not consenting for the study
About this study
Official title: Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH (Non-alcoholic Steato-hepatitis)
This study is to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic acid, antioxidant on patients with pathologically proved NASH (non-alcoholic steato-hepatitis).
Read the detailed description
Duration: 24 week-intervention Study Group: Four arms
- Control: no intervention
- Rosiglitazone: rosiglitazone (8 mg/day)
- alpha-lipoic acid: alpha-lipoic acid (1800 mg/day)
- Rosiglitazone/alpha-lipoic acid: combination of rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)
- Conditions
- NASH (Non-alcoholic Steato-hepatitis)
- Being tested
- Rosiglitazone, alpha-lipoic acid, Rosiglitazone/alpha-lipoic acid
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
Also called Avandia
Rosiglitazone (8 mg/day)
alpha-lipoic acidDrug
Also called Thioctic acid
alpha-lipoic acid (1800 mg/day)
Rosiglitazone/alpha-lipoic acidDrug
Also called Avandia/Thioctic acid
combination of Rosiglitazone (8 mg/day) and Thioctic acid (1800 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Rosiglitazone | Experimental | Rosiglitazone (8 mg/day) Receives: Drug: Rosiglitazone |
| alpha-lipoic acid | Experimental | alpha-lipoic acid (1800 mg/day) Receives: Drug: alpha-lipoic acid |
| Rosiglitazone/alpha-lipoic acid | Experimental | combination of Rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day) Receives: Drug: Rosiglitazone/alpha-lipoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological evaluation
NASH Histological scoring system
Measured: 24 weeks
Secondary outcomes (1)
Biomechanical measurement
liver function test, insulin resistance
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJan 2004
- Primary completionDec 2010
- Study completionDec 2013 (estimated)
Why it stopped: because of withdrawal of Avandia sale due to its risks outweigh its benefits
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH (Non-alcoholic Steato-hepatitis)Studies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Kun Ho Yoon, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406704
- Sponsor's protocol ID
- KCMC-04-14
- Status last verified
- Jan 2004
- First submitted
- 27 Jul 2011
- Last updated
- 19 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH (Non-alcoholic Steato-hepatitis)
- ClinicalTrials.gov ID
- NCT01406704
- Acronym / sponsor ID
- KCMC-04-14
- Conditions
- NASH (Non-alcoholic Steato-hepatitis)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: because of withdrawal of Avandia sale due to its risks outweigh its benefits
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2004
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 1 Aug 2011 (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 to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic acid, antioxidant on patients with pathologically proved NASH (non-alcoholic steato-hepatitis).
Detailed description
Duration: 24 week-intervention Study Group: Four arms
- Control: no intervention
- Rosiglitazone: rosiglitazone (8 mg/day)
- alpha-lipoic acid: alpha-lipoic acid (1800 mg/day)
- Rosiglitazone/alpha-lipoic acid: combination of rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Rosiglitazone | Experimental | Drug: RosiglitazoneRosiglitazone (8 mg/day) |
| alpha-lipoic acid | Experimental | Drug: alpha-lipoic acidalpha-lipoic acid (1800 mg/day) |
| Rosiglitazone/alpha-lipoic acid | Experimental | Drug: Rosiglitazone/alpha-lipoic acidcombination of Rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the patients with pathologically proved NASH (non-alcoholic steato-hepatitis)
Key exclusion criteria (10 listed)
- alcohol consumption > 20g/day
- viral hepatitis B and C
- autoimmune hepatitis
- Wilson's disease
- hemochromatosis
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 |
|---|---|---|
| RosiglitazoneAlso: AvandiaRosiglitazone (8 mg/day) | Drug | Rosiglitazone |
| alpha-lipoic acidAlso: Thioctic acidalpha-lipoic acid (1800 mg/day) | Drug | alpha-lipoic acid |
| Rosiglitazone/alpha-lipoic acidAlso: Avandia/Thioctic acidcombination of Rosiglitazone (8 mg/day) and Thioctic acid (1800 mg/day) | Drug | Rosiglitazone/alpha-lipoic acid |
Primary outcome
Histological evaluation
Time frame: 24 weeks
NASH Histological scoring system
1 secondary outcome
Biomechanical measurement
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: because of withdrawal of Avandia sale due to its risks outweigh its benefits). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
Related trials for NASH (Non-alcoholic Steato-hepatitis)
Recruiting
Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver.
Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Liver Fibrosis/NASH
Active, not recruiting
The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
Type 2 Diabetes Mellitus, Obesity
Active, not recruiting
Non-invasive Tests for Non-alcoholic Steato-hepatitis
NASH With Fibrosis, Diabete Type 2
Not yet recruiting
How Abnormal Function of Fat Tissue in Type 1 Diabetes Contributes to Fat in the Liver
Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-Alcoholic Steato-Hepatitis (NASH)
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.
Kun Ho Yoon principal investigator
Seoul St. Mary's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosiglitazone, alpha-lipoic acid and Rosiglitazone/alpha-lipoic acid in people with NASH (Non-alcoholic Steato-hepatitis), run by Seoul St. Mary's Hospital.
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 10 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: stopped early, as of the sponsor's last update on 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: because of withdrawal of Avandia sale due to its risks outweigh its benefits). Results are not available in the source record.
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?
Histological evaluation (time frame: 24 weeks). 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 Aug 2011.