Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR

NCT03659058 | Completed

• 1 other identifier: 37801
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

with the introduction of Direct-acting antiviral agents in the management of HCV, the scope of inclusion criteria had been widened to include patients with compensated cirrhosis and even in special situations patients with decompensated liver disease; a chance that was not offered by the limited and strict inclusion criteria needed for treatment by pegylated interferon-based regimen. this made the number of patients with progressive liver fibrosis of cirrhosis had been inv=creased even after achieving SVR. the debate about the impact of SVR on halting fibrosis progression had risen; some studies postulated that patients benefit from an SVR through reduction of mortality, morbidity, and improved quality of life ; however, some patients may maintain their level of fibrosis or even progress to cirrhosis despite achieving SVR and the risk for HCC remains even after virologic eradication.

Conditions

Fibrosis, Liver

Keywords

fibrosis; HCV; Reversal; sustained virological response

Outcome Measures

Primary Outcomes (3)

• Improvement in liver stiffness measurement by Fibroscan

  Liver stiffness assessment by Fibroscan every 6 months

  1 year

• Improved portal hypertension parameters

  Assessment of portal vein diameter, splenic vein diameter, portal vein congestive index by ultrasound and Doppler every 6 months

  1 year

• Improved splenic stiffness measurement

  assessment by ultrasound and fibroscan

  1 year

Study Arms (2)

study group

ACTIVE COMPARATOR

200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be treated by anti-fibrotic agents

Drug: silymarin; Drug: Ursodeoxycholic Acid; Drug: Antioxidants; Drug: Colchicine; Other: FOLLOW UP

control group

PLACEBO COMPARATOR

200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be followed up without any intervention

Other: FOLLOW UP

Interventions

silymarin DRUG

silymarin 140 three times daily

Also known as: silymarin 140

study group

Ursodeoxycholic Acid DRUG

Ursodeoxycholic Acid 500

Also known as: ursofalk

study group

Antioxidants DRUG

Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg

Also known as: antox

study group

Colchicine DRUG

Colchicine 0.6

study group

FOLLOW UP OTHER

follow up by abdominal ultrasound and fibroscan every 6 month for 1 year

Also known as: ultrasound and fibroscan

control group; study group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic HCV
• compensated liver disease (Child class A-B)
• sustained virological response
• liver stiffness by fibroscan \>12.5 kPa denotes cirrhosis

You may not qualify if:

• decompensated liver disease
• chronic active HCV
• hepatocellular carcinoma
• other liver diseases as alcoholic liver disease, autoimmune liver disease, drug-induced liver disease
• pregnancy

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis

Interventions

Silymarin; Ursodeoxycholic Acid; Antioxidants; Colchicine; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes; Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals; Alkaloids; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of medicine

Model Details: 200 patients will receive silymarin 420 mg + antioxidants + colchicine

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: September 6, 2018
• Study Start: March 2, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 27, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share