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

October 8, 2017 updated by: Ahmed Negida, Zagazig University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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%).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy measured by Sustained Virologic Response Rate
Time Frame: 12 weeks posttreatment
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)
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
Within the treatment period (12 or 24 weeks according to the treatment regimen)
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
Within the treatment period (12 or 24 weeks according to the treatment regimen)
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
Within the treatment period (12 or 24 weeks according to the treatment regimen)
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
Within the treatment period (12 or 24 weeks according to the treatment regimen)
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
Within the treatment period (12 or 24 weeks according to the treatment regimen)
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
Within the treatment period (12 or 24 weeks according to the treatment regimen)
Incidence of Fatigue [Safety]
Time Frame: Within the treatment period (12 or 24 weeks according to the treatment regimen)
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)
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)
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)
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)
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)
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)
Within the treatment period (12 or 24 weeks according to the treatment regimen)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zagazig University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Samah A Loutfy, National Cancer Institute, Cairo University, Cairo, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2667-20-3-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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