Clinical trial NCT00502086: Efficacy and Safety of Viusid in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cirrhosis
Chronic Hepatitis C
Keywords: Chronic hepatitis C
Cirrhosis of the liver
Mortality
Complications
Health-related quality of live
Hepatocellular carcinoma
Nutritional supplement
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2007-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The mortality secondary to liver failure at 96 weeks.
timeFrame: 96 weeks
Secondary outcomes:
measure: 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.
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Plaza de la Revolución
country: Cuba
facility: National Institute of Gastroenterology
state: Havana
Study officials:
affiliation: National Institute of Gastroenterology, Havana, Cuba
name: Eduardo Vilar Gómez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.