Efficacy and Safety of Viusid in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection.
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ClinicalTrials.gov Identifier: NCT00502086 |
Recruitment Status :
Completed
First Posted : July 17, 2007
Last Update Posted : February 11, 2011
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Condition or disease | Intervention/treatment | Phase |
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Cirrhosis Chronic Hepatitis C | Dietary Supplement: Viusid (nutritional supplement) Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | July 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: I
Viusid, three sachets daily during 96 weeks
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Dietary Supplement: Viusid (nutritional supplement)
Viusid three sachets daily during 96 weeks
Other Name: Nutritional supplement |
Placebo Comparator: 2
Placebo three sachets daily during 96 weeks
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Other: Placebo
Placebo three sachets daily during 96 weeks |
- The mortality secondary to liver failure at 96 weeks. [ Time Frame: 96 weeks ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Concomitant disease with reduced life expectancy.
- Severe psychiatric conditions.
- Co-infection with hepatitis A or B or HIV.
- Drug dependence.
- Pregnancy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502086
Cuba | |
National Institute of Gastroenterology | |
Plaza de la Revolución, Havana, Cuba, 10400 |
Principal Investigator: | Eduardo Vilar Gómez, PhD | National Institute of Gastroenterology, Havana, Cuba |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eduardo Vilar Gómez, National Institute of Gastroenterology |
ClinicalTrials.gov Identifier: | NCT00502086 |
Other Study ID Numbers: |
VIUHCV-07 |
First Posted: | July 17, 2007 Key Record Dates |
Last Update Posted: | February 11, 2011 |
Last Verified: | February 2010 |
Chronic hepatitis C Cirrhosis of the liver Mortality Complications |
Health-related quality of live Hepatocellular carcinoma Nutritional supplement |
Hepatitis A Hepatitis C Hepatitis C, Chronic Virus Diseases Hepatitis Hepatitis, Chronic Liver Cirrhosis Fibrosis |
Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Pathologic Processes |