Management of Decompensated HCV Cirrhotic Patients

NCT03547895 | Completed

• 1 other identifier: 3778
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

-The limited treatment varieties of decompensated cirrhosis due to hepatitis C virus (HCV) remain a challenge. In patients with reduced hepatic reserve, DAAs may be associated with complications as worsening decompensation. The impact of DAAs therapy on mortality in decompensated cirrhosis was not investigated.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• sustained virological response

  undetectable HCV RNA 3 months after treatment termination by Polymerase Chain Reaction

  3 months after 3 months after treatment termination

Secondary Outcomes (3)

• improved liver synthetic function

  24 months

• improved liver synthetic function

  24 months

• improved liver excretory function

  24 hours

Study Arms (2)

cases

ACTIVE COMPARATOR

patients with decompensated cirrhosis treated with Sofosbuvir 400 mg (Sovaldi) + Daclatasvir 60mg (Daklinza) + Ribavirin 200 mg (Rebetol)

Drug: Sofosbuvir 400mg (Sovaldi) + Daclatasvir 60 mg (Daklinza) + Ribavirin 200 mg (Rebetol)

control group

PLACEBO COMPARATOR

the control group treated with liver support including silymarin 140 + phytomenadione 10 mg + lasilactone 50 mg + albumin infusion

Drug: vitamin K (Phytomenadione) 10 mg+ furosemide and spironolactone (Lasilactone) 50 mg + milk thistle (Silymarin) 140 mg + Albumin infusion

Interventions

Sofosbuvir 400mg (Sovaldi) + Daclatasvir 60 mg (Daklinza) + Ribavirin 200 mg (Rebetol) DRUG

sofosbuvir 400mg+ribavirin 400mg+daclatasvir 60 mg were adminstered for 3 months

Also known as: Direct Acting Antivirals (DAAs)

cases

vitamin K (Phytomenadione) 10 mg+ furosemide and spironolactone (Lasilactone) 50 mg + milk thistle (Silymarin) 140 mg + Albumin infusion DRUG

symptomatic therapy for liver support, control of ascites and bleeding tendency.

Also known as: liver support therapy

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic active HCV proved by the positivity of HCV RNA, elevated transaminases.
• CTP score was \>9, MELD score was \<29
• Decompensated cirrhosis with frequent hepatic encephalopathy (HE) or difficult to treat ascites

You may not qualify if:

• exposure to previous antiviral therapy
• hepatocellular carcinoma
• other causes of liver diseases or mixed causes (excessive alcohol consumption, autoimmune liver disease)
• previous liver transplantation.

Sponsors & Collaborators

• Zagazig University: lead

Related Publications (1)

• Hanafy AS, Bassiony MA, Basha MAA. Management of HCV-related decompensated cirrhosis with direct-acting antiviral agents: who should be treated? Hepatol Int. 2019 Mar;13(2):165-172. doi: 10.1007/s12072-019-09933-8. Epub 2019 Feb 13.

  PMID: 30758786 DERIVED

MeSH Terms

Interventions

Sofosbuvir; daclatasvir; Ribavirin; Vitamin K; Vitamin K 1; Furosemide; Spironolactone; milk-thistle extract; Silymarin

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Polycyclic Compounds; Quinones; Sulfanilamides; Sulfonamides; Amides; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Lactones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Amr S Hanafy, md

  Assistant prof of medicine-Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: patients with decompensated cirrhosis with frequent hepatic encephalopathy (HE) or difficult to treat ascites were included if they had chronic active HCV

Study Record Dates

• First Submitted: May 27, 2017
• First Posted: June 6, 2018
• Study Start: June 1, 2015
• Primary Completion: May 24, 2016
• Study Completion: June 24, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share