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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02992457
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Sofosbuvir Drug: Ribavirin Drug: Pegylated-interferon alfa-2a Drug: Simeprevir Drug: Daclatasvir Drug: Ritaprevir, paritaprevir, ombetasvir Drug: Sofosbuvir and Ledipasvir Drug: Salvage therapy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Active Comparator: Sof-Riba
Sofosbuvir ribavirin 6 months.
Drug: Sofosbuvir
Sofosbuvir 400 mg daily.
Other Name: sovaldi , mpiviropack

Drug: Ribavirin
Ribavirin 1000-1200 mg daily
Other Name: Rebetol, Riba

Active Comparator: Sof- Riba- Pegylated interferon
Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months
Drug: Sofosbuvir
Sofosbuvir 400 mg daily.
Other Name: sovaldi , mpiviropack

Drug: Ribavirin
Ribavirin 1000-1200 mg daily
Other Name: Rebetol, Riba

Drug: Pegylated-interferon alfa-2a
Pegylated interferon alfa-2a once weekly for 3 months
Other Name: peginteron, pegasys

Active Comparator: Sof- Olysio
Sofosbuvir and simeprevir for 3 months.
Drug: Sofosbuvir
Sofosbuvir 400 mg daily.
Other Name: sovaldi , mpiviropack

Drug: Simeprevir
Olysio once daily.
Other Name: Olysio

Active Comparator: Sof- Dacla
Sofosbuvir and Daclatasvir for 3 months.
Drug: Sofosbuvir
Sofosbuvir 400 mg daily.
Other Name: sovaldi , mpiviropack

Drug: Daclatasvir
Dakla once daily for three months.
Other Name: Daklatasvir, Dakla

Active Comparator: Harvony
Sofosbuvir and ledipasvir for 3 months
Drug: Sofosbuvir and Ledipasvir
Once daily for three months
Other Name: Harvony

Active Comparator: Ritaprevir, paritaprevir, ombetasvir
Querevo for 3 months
Drug: Ritaprevir, paritaprevir, ombetasvir
Querevo for three months
Other Name: querevo

Active Comparator: Salvage therapy
sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo
Drug: Salvage therapy
three months in repeated treatment failure
Other Name: Sofosbuvir,simeprevir, daclatasvir, ribavirin or sofosbuvir and querevo




Primary Outcome Measures :
  1. Number of patients with sustained virological response. [ Time Frame: 2 months ]
    The number of patients achieving SVR



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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): NCT02992457


Locations
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Egypt
Sherief Abd-Elsalam
Tanta, Egypt
Tanta university hospital
Tanta, Egypt
Sponsors and Collaborators
Tanta University
Investigators
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Study Chair: Asem Elfert, Prof Tanta university hospital
Study Chair: Lobna Abo ALi, Ass Prof Tanta university hospital
Study Chair: Sabry Abou Saif, Ass Prof Tanta university hospital
Study Chair: Taher Eldemerdash, Prof Tanta University hospital
Study Chair: Hala M Elsabagh, Prof Tanta University hospital
Study Chair: Mohamed Elkassas, Lecturer Helwan University
Study Chair: Eslam Esmail, Ass Lecturer Tanta University
Study Director: Sherief Abd-Elsalam Tanta University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sherief Abd-Elsalam, Principle investigator, Tanta University
ClinicalTrials.gov Identifier: NCT02992457    
Other Study ID Numbers: Asem Elfert
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Interferon alpha-2
Sofosbuvir
Peginterferon alfa-2a
Ledipasvir
Simeprevir
Ledipasvir, sofosbuvir drug combination
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors