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

NCT ID: NCT02992457

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sof-Riba

Sofosbuvir ribavirin 6 months.

Group Type ACTIVE_COMPARATOR

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400 mg daily.

Ribavirin

Intervention Type DRUG

Ribavirin 1000-1200 mg daily

Sof- Riba- Pegylated interferon

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

Group Type ACTIVE_COMPARATOR

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400 mg daily.

Ribavirin

Intervention Type DRUG

Ribavirin 1000-1200 mg daily

Pegylated-interferon alfa-2a

Intervention Type DRUG

Pegylated interferon alfa-2a once weekly for 3 months

Sof- Olysio

Sofosbuvir and simeprevir for 3 months.

Group Type ACTIVE_COMPARATOR

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400 mg daily.

Simeprevir

Intervention Type DRUG

Olysio once daily.

Sof- Dacla

Sofosbuvir and Daclatasvir for 3 months.

Group Type ACTIVE_COMPARATOR

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400 mg daily.

Daclatasvir

Intervention Type DRUG

Dakla once daily for three months.

Harvony

Sofosbuvir and ledipasvir for 3 months

Group Type ACTIVE_COMPARATOR

Sofosbuvir and Ledipasvir

Intervention Type DRUG

Once daily for three months

Ritaprevir, paritaprevir, ombetasvir

Querevo for 3 months

Group Type ACTIVE_COMPARATOR

Ritaprevir, paritaprevir, ombetasvir

Intervention Type DRUG

Querevo for three months

Salvage therapy

sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo

Group Type ACTIVE_COMPARATOR

Salvage therapy

Intervention Type DRUG

three months in repeated treatment failure

Interventions

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Sofosbuvir

Sofosbuvir 400 mg daily.

Intervention Type DRUG

Ribavirin

Ribavirin 1000-1200 mg daily

Intervention Type DRUG

Pegylated-interferon alfa-2a

Pegylated interferon alfa-2a once weekly for 3 months

Intervention Type DRUG

Simeprevir

Olysio once daily.

Intervention Type DRUG

Daclatasvir

Dakla once daily for three months.

Intervention Type DRUG

Ritaprevir, paritaprevir, ombetasvir

Querevo for three months

Intervention Type DRUG

Sofosbuvir and Ledipasvir

Once daily for three months

Intervention Type DRUG

Salvage therapy

three months in repeated treatment failure

Intervention Type DRUG

Other Intervention Names

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sovaldi , mpiviropack Rebetol, Riba peginteron, pegasys Olysio Daklatasvir, Dakla querevo Harvony Sofosbuvir,simeprevir, daclatasvir, ribavirin or sofosbuvir and querevo

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asem Elfert, Prof

Role: STUDY_CHAIR

Tanta university hospital

Lobna Abo ALi, Ass Prof

Role: STUDY_CHAIR

Tanta university hospital

Sabry Abou Saif, Ass Prof

Role: STUDY_CHAIR

Tanta university hospital

Taher Eldemerdash, Prof

Role: STUDY_CHAIR

Tanta University hospital

Hala M Elsabagh, Prof

Role: STUDY_CHAIR

Tanta University hospital

Mohamed Elkassas, Lecturer

Role: STUDY_CHAIR

Helwan University

Eslam Esmail, Ass Lecturer

Role: STUDY_CHAIR

Tanta University

Sherief Abd-Elsalam

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

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Sherief Abd-Elsalam

Tanta, , Egypt

Site Status

Tanta university hospital

Tanta, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 32356185 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29535545 (View on PubMed)

Other Identifiers

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Asem Elfert

Identifier Type: -

Identifier Source: org_study_id

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