CirrhosisPhase 3NCT00502086
Efficacy and Safety of Viusid in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection.
A Phase 3 study testing Viusid (nutritional supplement) in people with Cirrhosis and Chronic Hepatitis C, run by Catalysis SL at 1 site in Cuba.
Trial summary
The purpose of the study is to evaluate whether Viusid, a nutritional supplement, reduce the mortality and the complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy, gastrointestinal bleeding, sepsis and hepatocellular carcinoma) of patients with cirrhosis of the liver… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis, Chronic Hepatitis C
- What is being tested?
- Viusid (nutritional supplement)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCuba
- Study dates
- May 2005to Jul 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or clinical diagnosis of cirrhosis.
- HCV infection confirmed on a positive test for anti-HCV antibody and HCV RNA detectable in serum by Polymerase Chain Reaction.
- Patients who were non-responders to previous treatment with pegylated interferon and ribavirin or naïve patients with decompensated cirrhosis (Child-Pugh score ≥ 7) who had contraindicated the antiviral treatment.
- Presence of compensated or decompensated (Stage A, B or C according to the Child-Pugh Classification).
- Absence of clinical and ultrasonographic evidence of liver cancer, with α-fetoprotein levels ≤ 200 ng/ml.
Who cannot join
- Age less than 18 or greater than 70 years.
- Presence of uncontrollable clinical or biochemical complications related to severe liver failure (hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding, serum bilirubin level greater than 5 mg/dL, international normalized ratio greater than 2.5).
- Active alcoholism.
- Serum creatinine greater than 2 mg/dL.
- Hepatocellular carcinoma.
- Refusal to participate in the study.
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- Concomitant disease with reduced life expectancy.
- Severe psychiatric conditions.
- Co-infection with hepatitis A or B or HIV.
- Drug dependence.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Cuba1 site
National Institute of Gastroenterology
Plaza de la Revolución, La Habana, 10400
About this study
Official title: Efficacy and Safety of Viusid, a Nutritional Supplement, in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection. A Randomized, Controlled and Double Blind Study.
The purpose of the study is to evaluate whether Viusid, a nutritional supplement, reduce the mortality and the complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy, gastrointestinal bleeding, sepsis and hepatocellular carcinoma) of patients with cirrhosis of the liver secondary to HCV infection in comparison with placebo, during 96 weeks of treatment.
- Conditions
- Cirrhosis, Chronic Hepatitis C
- Being tested
- Viusid (nutritional supplement), Placebo
- Keywords
- Chronic hepatitis C, Cirrhosis of the liver, Mortality, Complications, Health-related quality of live, Hepatocellular carcinoma, Nutritional supplement
- Medical subject headings
- Fibrosis, Hepatitis C, Chronic, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viusid (nutritional supplement)Dietary supplement
Also called Nutritional supplement
Viusid three sachets daily during 96 weeks
PlaceboOther
Placebo three sachets daily during 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Viusid, three sachets daily during 96 weeks Receives: Dietary Supplement: Viusid (nutritional supplement) |
| 2 | Placebo comparator | Placebo three sachets daily during 96 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mortality secondary to liver failure at 96 weeks.
Measured: 96 weeks
Secondary outcomes (1)
The complication rates during the treatment. The hepatitis-related quality of live during the treatment. Clinical Activity Index during the treatment. The hepatocellular carcinoma incidence during the treatment.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startMay 2005
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eduardo Vilar Gómez, PhD, Principal investigator, National Institute of Gastroenterology, Havana, Cuba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502086
- Sponsor's protocol ID
- VIUHCV-07
- Status last verified
- Feb 2010
- First submitted
- 13 Jul 2007
- Last updated
- 11 Feb 2011
- 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 17311621Vilar Gomez E, Sanchez Rodriguez Y, Torres Gonzalez A, Calzadilla Bertot L, Arus Soler E, Martinez Perez Y, Yasells Garcia A, Abreu Vazquez Mdel R. Viusid, a nutritional supplement, increases survival and reduces disease progression in HCV-related decompensated cirrhosis: a randomised and controlled trial. BMJ Open. 2011 Jan 1;1(2):e000140. doi: 10.1136/bmjopen-2011-000140.
PubMed 22021873
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. 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 Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection. A Randomized, Controlled and Double Blind Study.
- ClinicalTrials.gov ID
- NCT00502086
- Acronym / sponsor ID
- VIUHCV-07
- Conditions
- Cirrhosis, Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, Cirrhosis of the liver, Mortality, Complications, Health-related quality of live, Hepatocellular carcinoma, Nutritional supplement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 17 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, reduce the mortality and the complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy, gastrointestinal bleeding, sepsis and hepatocellular carcinoma) of patients with cirrhosis of the liver secondary to HCV infection in comparison with placebo, during 96 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Dietary Supplement: Viusid (nutritional supplement)Viusid, three sachets daily during 96 weeks |
| 2 | Placebo comparator | Other: PlaceboPlacebo three sachets daily during 96 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological or clinical diagnosis of cirrhosis.
- HCV infection confirmed on a positive test for anti-HCV antibody and HCV RNA detectable in serum by Polymerase Chain Reaction.
- Patients who were non-responders to previous treatment with pegylated interferon and ribavirin or naïve patients with decompensated cirrhosis (Child-Pugh score ≥ 7) who had contraindicated the antiviral treatment.
- Presence of compensated or decompensated (Stage A, B or C according to the Child-Pugh Classification).
- Absence of clinical and ultrasonographic evidence of liver cancer, with α-fetoprotein levels ≤ 200 ng/ml.
Key exclusion criteria (11 listed)
- Age less than 18 or greater than 70 years.
- Presence of uncontrollable clinical or biochemical complications related to severe liver failure (hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding, serum bilirubin level greater than 5 mg/dL, international normalized ratio greater than 2.5).
- Active alcoholism.
- Serum creatinine greater than 2 mg/dL.
- Hepatocellular carcinoma.
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 |
|---|---|---|
| Viusid (nutritional supplement)Also: Nutritional supplementViusid three sachets daily during 96 weeks | Dietary supplement | I |
| PlaceboPlacebo three sachets daily during 96 weeks | Other | 2 |
Primary outcome
The mortality secondary to liver failure at 96 weeks.
Time frame: 96 weeks
1 secondary outcome
The complication rates during the treatment. The hepatitis-related quality of live during the treatment. Clinical Activity Index during the treatment. The hepatocellular carcinoma incidence during the treatment.
Time frame: 96 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 11 Feb 2011.
- 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.
- Derived from this study: PubMed 22021873Vilar Gomez E, Sanchez Rodriguez Y, Torres Gonzalez A, Calzadilla Bertot L, Arus Soler E, Martinez Perez Y, Yasells Garcia A, Abreu Vazquez Mdel R. Viusid, a nutritional supplement, increases survival and reduces disease progression in HCV-related decompensated cirrhosis: a randomised and controlled trial. BMJ Open. 2011 Jan 1;1(2):e000140. doi: 10.1136/bmjopen-2011-000140.
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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.
Eduardo Vilar Gómez, PhD principal investigator
National Institute of Gastroenterology, Havana, Cuba
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 (nutritional supplement) in people with Cirrhosis and Chronic Hepatitis C, 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 5 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 11 Feb 2011. 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. Some participants in this study may receive a placebo. 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 mortality secondary to liver failure at 96 weeks. (time frame: 96 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 NCT00502086, which also lists 2 linked publications.
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 11 Feb 2011.