Efficacy and Safety of Viusid in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection.

• ClinicalTrials.gov Identifier: NCT00502086
• Recruitment Status: Completed
• First Posted: July 17, 2007
• Last Update Posted: February 11, 2011
• Sponsor: Catalysis SL
• Information provided by: Catalysis SL

Study Description

Brief 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 secondary to HCV infection in comparison with placebo, during 96 weeks of treatment.

Condition or disease	Intervention/treatment	Phase
Cirrhosis; Chronic Hepatitis C	Dietary Supplement: Viusid (nutritional supplement); Other: Placebo	Phase 3

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: I; Viusid, three sachets daily during 96 weeks	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	Other: Placebo; Placebo three sachets daily during 96 weeks

Outcome Measures

Primary Outcome Measures :

1. The mortality secondary to liver failure at 96 weeks. [ Time Frame: 96 weeks ]

Secondary Outcome Measures :

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. [ Time Frame: 96 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Cuba

National Institute of Gastroenterology

Plaza de la Revolución, Havana, Cuba, 10400

Sponsors and Collaborators

Catalysis SL

Investigators

• Principal Investigator: Eduardo Vilar Gómez, PhD; National Institute of Gastroenterology, Havana, Cuba

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vilar 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.

• Responsible Party: Eduardo Vilar Gómez, National Institute of Gastroenterology
• ClinicalTrials.gov Identifier: NCT00502086
• Other Study ID Numbers: VIUHCV-07
• First Posted: July 17, 2007
• Last Update Posted: February 11, 2011
• Last Verified: February 2010

Keywords provided by Catalysis SL:

Chronic hepatitis C; Cirrhosis of the liver; Mortality; Complications; Health-related quality of live; Hepatocellular carcinoma; Nutritional supplement

Additional relevant MeSH terms:

Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis; Infections; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Blood-Borne Infections; Communicable Diseases; Flaviviridae Infections; Pathologic Processes