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

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ClinicalTrials.gov Identifier: NCT02772744
Recruitment Status : Unknown
Verified October 2017 by Ahmed Negida, Zagazig University.
Recruitment status was:  Not yet recruiting
First Posted : May 13, 2016
Last Update Posted : October 10, 2017
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Ahmed Negida, Zagazig University

Tracking Information
First Submitted Date March 24, 2016
First Posted Date May 13, 2016
Last Update Posted Date October 10, 2017
Estimated Study Start Date November 1, 2017
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2016)
  • 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) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 11, 2016)
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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4
Official Title Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hepatitis C
Intervention
  • 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)
Study Groups/Cohorts
  • 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.

    Interventions:
    • Drug: Daclatasvir 60 MG Oral Tablet [Daklinza]
    • Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi]
  • 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.

    Interventions:
    • Drug: Daclatasvir 60 MG Oral Tablet [Daklinza]
    • Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi]
    • Drug: Ribavirin Oral Product
  • 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.
    Interventions:
    • Drug: Daclatasvir 60 MG Oral Tablet [Daklinza]
    • Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi]
    • Drug: Ribavirin Oral Product
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 11, 2016)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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%).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02772744
Other Study ID Numbers 2667-20-3-2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ahmed Negida, Zagazig University
Study Sponsor Zagazig University
Collaborators Cairo University
Investigators
Study Director: Samah A Loutfy National Cancer Institute, Cairo University, Cairo, Egypt
PRS Account Zagazig University
Verification Date October 2017