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

Primary Purpose

Cirrhosis, Chronic Hepatitis C

Status

Completed

Phase

Phase 3

Locations

Cuba

Study Type

Interventional

Intervention

Viusid (nutritional supplement)

Placebo

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring Chronic hepatitis C, Cirrhosis of the liver, Mortality, Complications, Health-related quality of live, Hepatocellular carcinoma, Nutritional supplement

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Institute of Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Viusid, three sachets daily during 96 weeks

Placebo three sachets daily during 96 weeks

Outcomes

Primary Outcome Measures

The mortality secondary to liver failure at 96 weeks.

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.

Full Information

NCT ID

NCT00502086

First Posted

July 13, 2007

Last Updated

February 10, 2011

Sponsor

Catalysis SL

1. Study Identification

Unique Protocol Identification Number

NCT00502086

Brief Title

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

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Catalysis SL

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis, Chronic Hepatitis C

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Viusid, three sachets daily during 96 weeks

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo three sachets daily during 96 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Viusid (nutritional supplement)

Other Intervention Name(s)

Nutritional supplement

Intervention Description

Viusid three sachets daily during 96 weeks

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo three sachets daily during 96 weeks

Primary Outcome Measure Information:

Title

The mortality secondary to liver failure at 96 weeks.

Time Frame

96 weeks

Secondary Outcome Measure Information:

Title

Time Frame

96 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eduardo Vilar Gómez, PhD

Organizational Affiliation

National Institute of Gastroenterology, Havana, Cuba

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institute of Gastroenterology

City

Plaza de la Revolución

State/Province

Havana

ZIP/Postal Code

10400

Country

Cuba

12. IPD Sharing Statement

Citations:

PubMed Identifier

17311621

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.

Results Reference

background

PubMed Identifier

22021873

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.

Results Reference

derived

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

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