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

Sponsored by:	Catalysis SL
Information provided by:	Catalysis SL
ClinicalTrials.gov Identifier:	NCT00502086

Purpose

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	Intervention	Phase
Cirrhosis Chronic Hepatitis C	Dietary Supplement: Viusid (nutritional supplement) Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis Dietary Supplements Hepatitis Hepatitis C

U.S. FDA Resources

Further study details as provided by Catalysis SL:

Primary Outcome Measures:

The mortality secondary to liver failure at 96 weeks. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	May 2005
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Viusid, three sachets daily during 96 weeks	Dietary Supplement: Viusid (nutritional supplement) Viusid three sachets daily during 96 weeks
2: Placebo Comparator Placebo three sachets daily during 96 weeks	Other: Placebo Placebo three sachets daily during 96 weeks

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502086

Locations

Cuba, Havana
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.

Responsible Party:	National Institute of Gastroenterology ( Eduardo Vilar Gómez )
Study ID Numbers:	VIUHCV-07
Study First Received:	July 13, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00502086 History of Changes
Health Authority:	Cuba: National Coordinating Center of Clinical Trials (CENCEC)

Keywords provided by Catalysis SL:

Chronic hepatitis C
Cirrhosis of the liver
Mortality
Complications

Health-related quality of live
Hepatocellular carcinoma
Nutritional supplement

Study placed in the following topic categories:

Liver Diseases
Hepatitis, Chronic
Carcinoma, Hepatocellular
Fibrosis
Hepatitis, Viral, Human
Liver Cirrhosis
Carcinoma

Hepatitis
Virus Diseases
Digestive System Diseases
Neoplasm Metastasis
Hepatitis C
Hepatocellular Carcinoma
Hepatitis C, Chronic

Additional relevant MeSH terms:

Liver Diseases
RNA Virus Infections
Hepatitis, Chronic
Flaviviridae Infections
Fibrosis
Hepatitis, Viral, Human
Liver Cirrhosis

Hepatitis
Virus Diseases
Digestive System Diseases
Pathologic Processes
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on September 11, 2009