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

NCT ID: NCT00502086

Last Updated: 2011-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2009-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

I

Viusid, three sachets daily during 96 weeks

Group Type: EXPERIMENTAL

Viusid (nutritional supplement)

Intervention Type: DIETARY_SUPPLEMENT

Viusid three sachets daily during 96 weeks

2

Placebo three sachets daily during 96 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo three sachets daily during 96 weeks

Interventions

Viusid (nutritional supplement)

Viusid three sachets daily during 96 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo three sachets daily during 96 weeks

Intervention Type: OTHER

Other Intervention Names

Nutritional supplement

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catalysis SL

INDUSTRY

Sponsor Role: lead

Responsible Party

National Institute of Gastroenterology

Principal Investigators

Eduardo Vilar Gómez, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Gastroenterology, Havana, Cuba

Locations

National Institute of Gastroenterology

Plaza de la Revolución, La Habana, Cuba

Countries

Cuba

References

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.

Reference Type: BACKGROUND

PMID: 17311621 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22021873 (View on PubMed)

Other Identifiers

VIUHCV-07

Identifier Type: -

Identifier Source: org_study_id