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

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Cirrhosis; Chronic Hepatitis C

Treatments: Other: Placebo; Dietary Supplement: Viusid (nutritional supplement)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00502086

VIUHCV-07

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups, including a placebo group

I

Experimental group

Description:

Viusid, three sachets daily during 96 weeks

Treatment:

Dietary Supplement: Viusid (nutritional supplement)

2

Placebo Comparator group

Description:

Placebo three sachets daily during 96 weeks

Treatment:

Other: Placebo