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Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Sofosbuvir
Ribavirin
Pegylated-interferon alfa-2a
Simeprevir
Daclatasvir
Ritaprevir, paritaprevir, ombetasvir
Sofosbuvir and Ledipasvir
Salvage therapy
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • HCV infection

    • Adult patients, 18years and older.

Exclusion Criteria:

  • • Child score > 12

    • Severe Renal impairment
    • Pregnant and lactating women
    • HCC or other malignant neoplasms
    • Co-infection with human immunodeficiency virus (HIV)
    • Co-infection with hepatitis B virus (HBV)

Sites / Locations

  • Sherief Abd-Elsalam
  • Tanta university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Sof-Riba

Sof- Riba- Pegylated interferon

Sof- Olysio

Sof- Dacla

Harvony

Ritaprevir, paritaprevir, ombetasvir

Salvage therapy

Arm Description

Sofosbuvir ribavirin 6 months.

Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months

Sofosbuvir and simeprevir for 3 months.

Sofosbuvir and Daclatasvir for 3 months.

Sofosbuvir and ledipasvir for 3 months

Querevo for 3 months

sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo

Outcomes

Primary Outcome Measures

Number of patients with sustained virological response.
The number of patients achieving SVR

Secondary Outcome Measures

Full Information

First Posted
December 6, 2016
Last Updated
August 23, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT02992457
Brief Title
Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection
Official Title
Study of the Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With and Without Post-hepatitis C Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in Egypt. For decades the antiviral therapy of chronic HCV infection was based on the administration of Interferon(IFN), initially alone and then in combination with Ribavirin (RBV), but this regimen was effective in only 50% of patients with genotype 1, with significant side effects.
Detailed Description
Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in Egypt. For decades the antiviral therapy of chronic HCV infection was based on the administration ofInterferon(IFN), initially alone and then in combination with Ribavirin (RBV), but this regimen was effective in only 50% of patients with genotype 1, with significant side effects. The introduction of direct acting antiviral agents, in particular sofosbuvir (SOF), has revolutionized the treatment for chronic hepatitis C virus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sof-Riba
Arm Type
Active Comparator
Arm Description
Sofosbuvir ribavirin 6 months.
Arm Title
Sof- Riba- Pegylated interferon
Arm Type
Active Comparator
Arm Description
Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months
Arm Title
Sof- Olysio
Arm Type
Active Comparator
Arm Description
Sofosbuvir and simeprevir for 3 months.
Arm Title
Sof- Dacla
Arm Type
Active Comparator
Arm Description
Sofosbuvir and Daclatasvir for 3 months.
Arm Title
Harvony
Arm Type
Active Comparator
Arm Description
Sofosbuvir and ledipasvir for 3 months
Arm Title
Ritaprevir, paritaprevir, ombetasvir
Arm Type
Active Comparator
Arm Description
Querevo for 3 months
Arm Title
Salvage therapy
Arm Type
Active Comparator
Arm Description
sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
sovaldi , mpiviropack
Intervention Description
Sofosbuvir 400 mg daily.
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Rebetol, Riba
Intervention Description
Ribavirin 1000-1200 mg daily
Intervention Type
Drug
Intervention Name(s)
Pegylated-interferon alfa-2a
Other Intervention Name(s)
peginteron, pegasys
Intervention Description
Pegylated interferon alfa-2a once weekly for 3 months
Intervention Type
Drug
Intervention Name(s)
Simeprevir
Other Intervention Name(s)
Olysio
Intervention Description
Olysio once daily.
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Other Intervention Name(s)
Daklatasvir, Dakla
Intervention Description
Dakla once daily for three months.
Intervention Type
Drug
Intervention Name(s)
Ritaprevir, paritaprevir, ombetasvir
Other Intervention Name(s)
querevo
Intervention Description
Querevo for three months
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir and Ledipasvir
Other Intervention Name(s)
Harvony
Intervention Description
Once daily for three months
Intervention Type
Drug
Intervention Name(s)
Salvage therapy
Other Intervention Name(s)
Sofosbuvir,simeprevir, daclatasvir, ribavirin or sofosbuvir and querevo
Intervention Description
three months in repeated treatment failure
Primary Outcome Measure Information:
Title
Number of patients with sustained virological response.
Description
The number of patients achieving SVR
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • HCV infection Adult patients, 18years and older. Exclusion Criteria: • Child score > 12 Severe Renal impairment Pregnant and lactating women HCC or other malignant neoplasms Co-infection with human immunodeficiency virus (HIV) Co-infection with hepatitis B virus (HBV)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asem Elfert, Prof
Organizational Affiliation
Tanta university hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lobna Abo ALi, Ass Prof
Organizational Affiliation
Tanta university hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sabry Abou Saif, Ass Prof
Organizational Affiliation
Tanta university hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Taher Eldemerdash, Prof
Organizational Affiliation
Tanta University hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hala M Elsabagh, Prof
Organizational Affiliation
Tanta University hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed Elkassas, Lecturer
Organizational Affiliation
Helwan University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eslam Esmail, Ass Lecturer
Organizational Affiliation
Tanta University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Facility Name
Tanta university hospital
City
Tanta
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32356185
Citation
Said EM, Abdulaziz BA, El Kassas M, El Attar IH, Emadeldeen M, Abd-Elsalam SM. High success rates for the use of sofosbuvir/ombitasvir/paritaprevir/ritonavir + ribavirin and sofosbuvir/simeprevir/daclatasvir + ribavirin in retreatment of chronic hepatitis C infection after unsuccessful sofosbuvir/daclatasvir therapy: a real-life experience. Arch Virol. 2020 Jul;165(7):1633-1639. doi: 10.1007/s00705-020-04639-x. Epub 2020 Apr 30.
Results Reference
derived
PubMed Identifier
29535545
Citation
Ahmed OA, Kaisar HH, Badawi R, Hawash N, Samir H, Shabana SS, Fouad MHA, Rizk FH, Khodeir SA, Abd-Elsalam S. Efficacy and safety of sofosbuvir-ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection. Infect Drug Resist. 2018 Mar 1;11:295-298. doi: 10.2147/IDR.S153060. eCollection 2018.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection

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