NCT03241823

Brief Summary

Hepatitis C Virus (HCV) infection is a major global health challenge; it is estimated that more than 80 million people are chronically infected worldwide, with 3-4 million new infections and 350,000 deaths occurring each year because of HCV-related complications .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

August 3, 2017

Last Update Submit

August 5, 2017

Conditions

Hepatitis CLiver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Changes in liver fibrosis

    Using non-invasive measures "Fibroscan"

    1 year.

Secondary Outcomes (2)

  • Changes occurring in liver haemodynamics

    1 year.

  • Changes in severity of liver disease

    1 year

Study Arms (1)

Patients with hepatitis c virus related liver cirrhosis

Patients with chronic hepatitis C virus whose ultrasound shows liver cirrhosis, fibroscan "F3 and F4, Child score "A and B", of any MELD score, who achieved Sustained Virological Response after direct acting antiviral drugs (Sofosbuvir, Daclatasvir ± Ribavirin).

Diagnostic Test: Abdominal ultrasound .Diagnostic Test: Model for End-Stage Liver DiseaseDiagnostic Test: Fibro Scan.Diagnostic Test: Child-Turcotte-Pugh score.

Interventions

Abdominal ultrasound .DIAGNOSTIC_TEST

Abdominal ultrasound for each patient before and after treatment.

Patients with hepatitis c virus related liver cirrhosis
Model for End-Stage Liver DiseaseDIAGNOSTIC_TEST

Model for End-Stage Liver Disease before and after treatment.

Patients with hepatitis c virus related liver cirrhosis
Fibro Scan.DIAGNOSTIC_TEST

Liver stiffness by Fibro scan before and after treatment.

Patients with hepatitis c virus related liver cirrhosis
Child-Turcotte-Pugh score.DIAGNOSTIC_TEST

Child-Turcotte-Pugh score before and after treatment

Patients with hepatitis c virus related liver cirrhosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100 patients with chronic hepatitis C virus related liver cirrhosis who achieved Sustained virological response after direct acting antiviral drugs (Sofosbuvir, Daclatasvir ± Ribavirin) and other available suitable regimens for 12 or 24 weeks will be selected from Assuit unit of treatment of viral hepatitis.

You may qualify if:

  • Age: ≥ 18 years.
  • Disease status: patients with hepatitis C Virus related liver cirrhosis child A\& B (scores 5-9).
  • Previous treatment: treatment naïve and treatment experienced.
  • HCV RNA: Negative at any point between 12-24 weeks post treatment to confirm successful eradication of the virus.
  • Negative HBsAg and HIV antibody.
  • Normal kidney function test

You may not qualify if:

  • Child C liver cirrhosis (Child score ≥ 10).
  • HCV coinfection with HBV or HIV.
  • Patients with high risk of infection (I.V drug users, patients with blood disease requiring blood transfusion).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit Unit of Treatment of Viral Hepatitis.

Asyut, 71111, Egypt

Location

Related Publications (5)

  • Arase Y, Kobayashi M, Suzuki F, Suzuki Y, Kawamura Y, Akuta N, Kobayashi M, Sezaki H, Saito S, Hosaka T, Ikeda K, Kumada H, Kobayashi T. Effect of type 2 diabetes on risk for malignancies includes hepatocellular carcinoma in chronic hepatitis C. Hepatology. 2013 Mar;57(3):964-73. doi: 10.1002/hep.26087. Epub 2013 Feb 7.

    PMID: 22991257BACKGROUND

  • Bruno S, Di Marco V, Iavarone M, Roffi L, Crosignani A, Calvaruso V, Aghemo A, Cabibbo G, Vigano M, Boccaccio V, Craxi A, Colombo M, Maisonneuve P. Survival of patients with HCV cirrhosis and sustained virologic response is similar to the general population. J Hepatol. 2016 Jun;64(6):1217-23. doi: 10.1016/j.jhep.2016.01.034. Epub 2016 Apr 5.

    PMID: 27059129BACKGROUND

  • Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, Brown RS Jr, Fried MW, Terrault NA, O'Leary JG, Vargas HE, Kuo A, Schiff E, Sulkowski MS, Gilroy R, Watt KD, Brown K, Kwo P, Pungpapong S, Korenblat KM, Muir AJ, Teperman L, Fontana RJ, Denning J, Arterburn S, Dvory-Sobol H, Brandt-Sarif T, Pang PS, McHutchison JG, Reddy KR, Afdhal N; SOLAR-1 Investigators. Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease. Gastroenterology. 2015 Sep;149(3):649-59. doi: 10.1053/j.gastro.2015.05.010. Epub 2015 May 15.

    PMID: 25985734BACKGROUND

  • Claudon M, Dietrich CF, Choi BI, Cosgrove DO, Kudo M, Nolsoe CP, Piscaglia F, Wilson SR, Barr RG, Chammas MC, Chaubal NG, Chen MH, Clevert DA, Correas JM, Ding H, Forsberg F, Fowlkes JB, Gibson RN, Goldberg BB, Lassau N, Leen EL, Mattrey RF, Moriyasu F, Solbiati L, Weskott HP, Xu HX; World Federation for Ultrasound in Medicine; European Federation of Societies for Ultrasound. Guidelines and good clinical practice recommendations for Contrast Enhanced Ultrasound (CEUS) in the liver - update 2012: A WFUMB-EFSUMB initiative in cooperation with representatives of AFSUMB, AIUM, ASUM, FLAUS and ICUS. Ultrasound Med Biol. 2013 Feb;39(2):187-210. doi: 10.1016/j.ultrasmedbio.2012.09.002. Epub 2012 Nov 5.

    PMID: 23137926BACKGROUND

  • Enomoto M, Mori M, Ogawa T, Fujii H, Kobayashi S, Iwai S, Morikawa H, Tamori A, Sakaguchi H, Sawada A, Takeda S, Habu D, Shiomi S, Kawada N. Usefulness of transient elastography for assessment of liver fibrosis in chronic hepatitis B: Regression of liver stiffness during entecavir therapy. Hepatol Res. 2010 Sep;40(9):853-61. doi: 10.1111/j.1872-034X.2010.00687.x.

    PMID: 20887589BACKGROUND

MeSH Terms

Conditions

Hepatitis CLiver Cirrhosis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ibrahim Taha, MSc

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherif Kamel, MD

CONTACT

00201222303690shereef_kamel@yahoo.com

Sahar Hassany, MD

CONTACT

00201010431017saharhassany@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 8, 2017

Study Start

December 1, 2017

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

EG(1)