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Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4

This study is not yet open for participant recruitment.
Verified October 2017 by Ahmed Negida, Zagazig University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02772744
First Posted: May 13, 2016
Last Update Posted: October 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Cairo University
Information provided by (Responsible Party):
Ahmed Negida, Zagazig University
  Purpose
This is a prospective, cohort study in Faculty of Medicine, Zagazig University, Egypt. From June to December, 2016, investigators will follow up patients with chronic Hepatitis C virus genotype 4 receiving daclatasvir-sofosbuvir treatment regimen within the national program of Egyptian ministry of health and population. The primary outcomes are safety of the treatment and the sustained virologic response 12 weeks after discontinuation of therapy. For the secondary outcomes, investigators will measure the change in health related quality of life and investigate the genetic sequence of viral RNA of resistant patients.

Condition Intervention
Hepatitis C Drug: Daclatasvir 60 MG Oral Tablet [Daklinza] Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi] Drug: Ribavirin Oral Product

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4

Resource links provided by NLM:


Further study details as provided by Ahmed Negida, Zagazig University:

Primary Outcome Measures:
  • Efficacy measured by Sustained Virologic Response Rate [ Time Frame: 12 weeks posttreatment ]
  • Incidence of grade 3/4 adverse events [Safety] [ Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen) ]
  • Incidence of Neutropenia [Safety] [ Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen) ]
    Neutropenia: Grade 3, 500-749/mm3; Grade 4, <500/mm3

  • Incidence of Lymphopenia [Safety] [ Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen) ]
    Lymphopenia: Grade 3, 350-499/mm3; Grade 4, <350/mm3

  • Incidence of anaemia [Safety] [ Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen) ]
    Anaemia: Grade 3, haemoglobin 7.0-8.9 g/dL; Grade 4, <7.0 g/dL

  • Incidence of Thrombocytopenia [Safety] [ Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen) ]
    Thrombocytopenia: Grade 3, 25 000-49 999/mm3; Grade 4, <25 000/mm3

  • Incidence of (Increased total Bilirubin) [Safety] [ Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen) ]
    Bilirubin elevations: Grade 3, 2.6-5×ULN; Grade 4, >5×ULN

  • Incidence of elevated Alanine Aminotransferase [Safety] [ Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen) ]
    Alanine Aminotransferase elevations: Grade 3, 5.1-10×upper limit of normal (ULN); Grade 4, >10×ULN

  • Incidence of Fatigue [Safety] [ Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen) ]
  • Incidence of Headache [Safety] [ Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen) ]
  • Incidence of Pruritus [Safety] [ Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen) ]
  • Incidence of Insomnia [Safety] [ Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen) ]
  • Incidence of Rash [Safety] [ Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen) ]
  • Incidence of Nausea [Safety] [ Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen) ]
  • Incidence of Myalgia [Safety] [ Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen) ]

Secondary Outcome Measures:
  • Health Related Quality of Life (HRQoL) [ Time Frame: 24 weeks ]
    HRQoL will be assessed using the Arabic version of SF-36 questionnaire (SF-36™ Health Survey)


Estimated Enrollment: 250
Anticipated Study Start Date: November 1, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1: Easy to treat group
  • Treatment naïve
  • Total serum bilirubin ≤ 1.2 mg/dl
  • Serum albumin ≥ 3.5 g/dl
  • International normalized ratio ≤ 1.2
  • Platelet count ≥ 150000 mm3

This group will be receiving Sofosbuvir + daclatasvir for 12 weeks.

Drug: Daclatasvir 60 MG Oral Tablet [Daklinza]
Daclatasvir (60 MG) is a potent, pan-genotypic inhibitor of the HCV NS5A protein
Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi]
Sofosbuvir (400 MG) is a nucleotide analogue HCV NS5B polymerase inhibitor
Group 2: Difficult to treat group
  • Peg interferon treatment experienced.
  • Total serum bilirubin ≥ 1.2 mg/dl
  • Serum albumin ≤ 3.5 g/dl
  • International normalized ratio ≥ 1.2
  • Platelet count ≤ 150000 mm3

This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 12 weeks.

Drug: Daclatasvir 60 MG Oral Tablet [Daklinza]
Daclatasvir (60 MG) is a potent, pan-genotypic inhibitor of the HCV NS5A protein
Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi]
Sofosbuvir (400 MG) is a nucleotide analogue HCV NS5B polymerase inhibitor
Drug: Ribavirin Oral Product
Ribavirin (twice-daily) dosed according to body weight (<75 kg, 1000 mg daily; ≥75 kg, 1200 mg daily)
Group 3: Sofosbuvir resistant cases
This is the group of patients who failed in previous Sofosbuvir treatment regiment. This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 24 weeks.
Drug: Daclatasvir 60 MG Oral Tablet [Daklinza]
Daclatasvir (60 MG) is a potent, pan-genotypic inhibitor of the HCV NS5A protein
Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi]
Sofosbuvir (400 MG) is a nucleotide analogue HCV NS5B polymerase inhibitor
Drug: Ribavirin Oral Product
Ribavirin (twice-daily) dosed according to body weight (<75 kg, 1000 mg daily; ≥75 kg, 1200 mg daily)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will include male or female patients ≥ 18 years, HCV RNA≥ 104 IU/mL, HCV genotype 4, screening ECG without clinically significant abnormalities.
Criteria

Inclusion Criteria:

  • Patients with HCV genotype 4
  • Age ≥ 18 years
  • HCV RNA≥ 104 IU/mL
  • Screening ECG without clinically significant abnormalities.

Exclusion Criteria:

  • Total serum bilirubin > 3 mg/dl.
  • Serum albumin < 2.8 g/dl.
  • INR ≥ 1.7
  • Platelet count < 50000/mm3.
  • Hepatic cell carcinoma except four weeks after intervention aiming to cure with no evidence of activity by dynamic imaging (CT or MRI).
  • Extra hepatic malignancy except after two years of disease free interval
  • Pregnancy or inability to use contraception.
  • Inadequately controlled diabetes mellitus (HbA1c > 9%).
  Contacts and Locations
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): NCT02772744


Contacts
Contact: Ahmed Negida +201125549087 ahmed01251@medicine.zu.edu.eg
Contact: Hussien Ahmed, MD +201006037334 hoseen011232@medicine.zu.edu.eg

Sponsors and Collaborators
Zagazig University
Cairo University
Investigators
Study Director: Samah A Loutfy National Cancer Institute, Cairo University, Cairo, Egypt
  More Information

Additional Information:
Publications:
Responsible Party: Ahmed Negida, Mr., Zagazig University
ClinicalTrials.gov Identifier: NCT02772744     History of Changes
Other Study ID Numbers: 2667-20-3-2016
First Submitted: March 24, 2016
First Posted: May 13, 2016
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ahmed Negida, Zagazig University:
Hepatitis C virus genotype 4
Antiviral
Virologic Response

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents