Nonalcoholic SteatohepatitisPhase 3NCT00509418
Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis
A Phase 3 study testing Viusid in people with Nonalcoholic Steatohepatitis, run by Catalysis SL at 1 site in Cuba.
Trial summary
The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in combination with diet and exercise improve the histological results (steatosis, necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- Viusid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCuba
- Study dates
- Feb 2007to Sep 2007
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis)
- Age between 18 and 70 years
- Ability to provide informed consent
- Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)
Who cannot join
- Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency)
- Pregnancy or lactation
- Decompensated cirrhosis
- Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery
- Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil
- Fasting glucose levels greater than 250 mg per deciliter (13.3 mmol per liter)
Show all 11Show fewer
- Contraindication to liver biopsy
- Refusal to participate in the study
- Concomitant disease with reduced life expectancy
- Severe psychiatric conditions
- Drug dependence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Viusid, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized, Controlled and Open Label Study
The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in combination with diet and exercise improve the histological results (steatosis, necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24 weeks of treatment.
- Conditions
- Nonalcoholic Steatohepatitis
- Being tested
- Viusid, Hypocaloric Diet with controlled exercise
- Keywords
- Nonalcoholic steatohepatitis, Nonalcoholic Fatty Liver, Nutritional supplement, Diet, Exercise
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViusidDietary supplement
Also called Nutritional supplement
Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks
Hypocaloric Diet with controlled exerciseOther
Also called lifestyle modification
Modified ADA diet in combination with controlled exercise daily 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Viusid, a nutritional supplement, in combination with controlled diet and exercise Receives: Dietary Supplement: Viusid |
| B | Active comparator | Controlled diet and exercise Receives: Other: Hypocaloric Diet with controlled exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment).
Measured: 24 weeks
Secondary outcomes (1)
Alanine aminotransferase levels (end of the treatment), δ-glutamyltransferase levels (end of the treatment), Body weight, Body Mass Index, Waist circumference (end of the treatment) Insulin resistance (HOMA) (end of the treatment)
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 posted31 Jul 2007 (estimated)
- Study startFeb 2007
- Primary completionSep 2007
- Study completionSep 2007
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Adelaida Rodríguez de Miranda, MD, Principal investigator, National Institute of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509418
- Sponsor's protocol ID
- VIUNASH-07
- Status last verified
- Jan 2009
- First submitted
- 30 Jul 2007
- Last updated
- 12 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vilar Gomez E, Gra Oramas B, Soler E, Llanio Navarro R, Ruenes Domech C. Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C. Liver Int. 2007 Mar;27(2):247-59. doi: 10.1111/j.1478-3231.2006.01411.x.
PubMed 17311621
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Viusid, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized, Controlled and Open Label Study
- ClinicalTrials.gov ID
- NCT00509418
- Acronym / sponsor ID
- VIUNASH-07
- Conditions
- Nonalcoholic Steatohepatitis
- Keywords
- Nonalcoholic steatohepatitis, Nonalcoholic Fatty Liver, Nutritional supplement, Diet, Exercise
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 31 Jul 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.
The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in combination with diet and exercise improve the histological results (steatosis, necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: ViusidViusid, a nutritional supplement, in combination with controlled diet and exercise |
| B | Active comparator | Other: Hypocaloric Diet with controlled exerciseControlled diet and exercise |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis)
- Age between 18 and 70 years
- Ability to provide informed consent
- Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)
Key exclusion criteria (11 listed)
- Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency)
- Pregnancy or lactation
- Decompensated cirrhosis
- Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery
- Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil
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 |
|---|---|---|
| ViusidAlso: Nutritional supplementViusid, a nutritional supplement. Three oral sachets Daily 24 weeks | Dietary supplement | A |
| Hypocaloric Diet with controlled exerciseAlso: lifestyle modificationModified ADA diet in combination with controlled exercise daily 24 weeks | Other | B |
Primary outcome
The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment).
Time frame: 24 weeks
1 secondary outcome
Alanine aminotransferase levels (end of the treatment), δ-glutamyltransferase levels (end of the treatment), Body weight, Body Mass Index, Waist circumference (end of the treatment) Insulin resistance (HOMA) (end of the treatment)
Time frame: 24 weeks
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 12 Jan 2009.
- Background: PubMed 17311621Vilar Gomez E, Gra Oramas B, Soler E, Llanio Navarro R, Ruenes Domech C. Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C. Liver Int. 2007 Mar;27(2):247-59. doi: 10.1111/j.1478-3231.2006.01411.x.
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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.
Adelaida Rodríguez de Miranda, MD principal investigator
National Institute of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Viusid in people with Nonalcoholic Steatohepatitis, run by Catalysis SL at 1 site in Cuba.
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: finished, as of the sponsor's last update on 12 Jan 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 Cuba. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment). (time frame: 24 weeks). 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 NCT00509418, 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 12 Jan 2009.