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Assessment of Patients With Hepatitis C Virus Related Liver Cirrhosis After Sustained Response to Direct Acting Anti Viral Drugs.

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ClinicalTrials.gov Identifier: NCT03241823
Recruitment Status : Unknown
Verified August 2017 by Ibrahim Taha, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : August 8, 2017
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
Ibrahim Taha, Assiut University

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 .

Condition or disease Intervention/treatment
Hepatitis C Liver Cirrhosis Diagnostic Test: Abdominal ultrasound . Diagnostic Test: Model for End-Stage Liver Disease Diagnostic Test: Fibro Scan. Diagnostic Test: Child-Turcotte-Pugh score.

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Hepatic Fibrosis, Hemodynamics, and Disease Severity of Patients With Hepatitis C Virus Related Liver Cirrhosis After Sustained Response to Direct Acting Anti Viral Drugs.
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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 .
Abdominal ultrasound for each patient before and after treatment.

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

Diagnostic Test: Fibro Scan.
Liver stiffness by Fibro scan before and after treatment.

Diagnostic Test: Child-Turcotte-Pugh score.
Child-Turcotte-Pugh score before and after treatment




Primary Outcome Measures :
  1. Changes in liver fibrosis [ Time Frame: 1 year. ]
    Using non-invasive measures "Fibroscan"


Secondary Outcome Measures :
  1. Changes occurring in liver haemodynamics [ Time Frame: 1 year. ]
    Using Doppler ultrasound.

  2. Changes in severity of liver disease [ Time Frame: 1 year ]
    Using Child-Pugh score.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241823


Contacts
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Contact: Sherif Kamel, MD 00201222303690 shereef_kamel@yahoo.com
Contact: Sahar Hassany, MD 00201010431017 saharhassany@yahoo.com

Locations
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Egypt
Assuit Unit of Treatment of Viral Hepatitis. Not yet recruiting
Assuit, Egypt, 71111
Contact: Waleed Hassan, MD    00201020066191    wallo403a@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Ibrahim Taha, MSc Assiut University

Publications:

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Responsible Party: Ibrahim Taha, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03241823     History of Changes
Other Study ID Numbers: AOHF
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Fibrosis
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Liver Extracts
Antiviral Agents
Hematinics
Anti-Infective Agents