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

NCT00502086 | Completed Phase 3 DMC

• 1 other identifier: VIUHCV-07
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Chronic Hepatitis C

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The mortality secondary to liver failure at 96 weeks.

  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.

  96 weeks

Study Arms (2)

I

EXPERIMENTAL

Viusid, three sachets daily during 96 weeks

Dietary Supplement: Viusid (nutritional supplement)

2

PLACEBO COMPARATOR

Placebo three sachets daily during 96 weeks

Other: Placebo

Interventions

Viusid (nutritional supplement) DIETARY_SUPPLEMENT

Viusid three sachets daily during 96 weeks

Also known as: Nutritional supplement

I

Placebo OTHER

Placebo three sachets daily during 96 weeks

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

National Institute of Gastroenterology

Plaza de la Revolución, La Habana, 10400, Cuba

Location

Related Publications (2)

• 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.

  PMID: 17311621 BACKGROUND

• 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.

  PMID: 22021873 DERIVED

MeSH Terms

Conditions

Fibrosis; Hepatitis C, Chronic; Carcinoma, Hepatocellular

Interventions

Viusid; Dietary Supplements

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Eduardo Vilar Gómez, PhD

  National Institute of Gastroenterology, Havana, Cuba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 13, 2007
• First Posted: July 17, 2007
• Study Start: May 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: February 11, 2011

Record last verified: 2010-02

Locations

CU (1)