Hepatitis CPhase 4NCT02992457
Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection
A Phase 4 study testing Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a in people with Hepatitis C, run by Tanta University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 2 sitesEgypt
- Study dates
- Jan 2015to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • HCV infection
- Adult patients, 18years and older.
Who cannot join
- • 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)
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Sofosbuvir, Ribavirin, Pegylated-interferon alfa-2a, Simeprevir, Daclatasvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofosbuvirDrug
Also called sovaldi , mpiviropack
Sofosbuvir 400 mg daily.
RibavirinDrug
Also called Rebetol, Riba
Ribavirin 1000-1200 mg daily
Pegylated-interferon alfa-2aDrug
Also called peginteron, pegasys
Pegylated interferon alfa-2a once weekly for 3 months
SimeprevirDrug
Also called Olysio
Olysio once daily.
DaclatasvirDrug
Also called Daklatasvir, Dakla
Dakla once daily for three months.
Ritaprevir, paritaprevir, ombetasvirDrug
Also called querevo
Querevo for three months
Sofosbuvir and LedipasvirDrug
Also called Harvony
Once daily for three months
Salvage therapyDrug
Also called Sofosbuvir,simeprevir, daclatasvir, ribavirin or sofosbuvir and querevo
three months in repeated treatment failure
| Study group | Role | What they receive |
|---|---|---|
| Sof-Riba | Active comparator | Sofosbuvir ribavirin 6 months. Receives: Drug: Sofosbuvir; Drug: Ribavirin |
| Sof- Riba- Pegylated interferon | Active comparator | Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months Receives: Drug: Sofosbuvir; Drug: Ribavirin; Drug: Pegylated-interferon alfa-2a |
| Sof- Olysio | Active comparator | Sofosbuvir and simeprevir for 3 months. Receives: Drug: Sofosbuvir; Drug: Simeprevir |
| Sof- Dacla | Active comparator | Sofosbuvir and Daclatasvir for 3 months. Receives: Drug: Sofosbuvir; Drug: Daclatasvir |
| Harvony | Active comparator | Sofosbuvir and ledipasvir for 3 months Receives: Drug: Sofosbuvir and Ledipasvir |
| Ritaprevir, paritaprevir, ombetasvir | Active comparator | Querevo for 3 months Receives: Drug: Ritaprevir, paritaprevir, ombetasvir |
| Salvage therapy | Active comparator | sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo Receives: Drug: Salvage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with sustained virological response.
The number of patients achieving SVR
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Asem Elfert, Prof, Study chair, Tanta university hospitalLobna Abo ALi, Ass Prof, Study chair, Tanta university hospitalSabry Abou Saif, Ass Prof, Study chair, Tanta university hospitalTaher Eldemerdash, Prof, Study chair, Tanta University hospitalHala M Elsabagh, Prof, Study chair, Tanta University hospitalMohamed Elkassas, Lecturer, Study chair, Helwan UniversityEslam Esmail, Ass Lecturer, Study chair, Tanta UniversitySherief Abd-Elsalam, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992457
- Sponsor's protocol ID
- Asem Elfert
- Status last verified
- Aug 2023
- First submitted
- 6 Dec 2016
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32356185Ahmed 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.
PubMed 29535545
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02992457
- Acronym / sponsor ID
- Asem Elfert
- Conditions
- Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Sof-Riba | Active comparator | Drug: Sofosbuvir, Drug: RibavirinSofosbuvir ribavirin 6 months. |
| Sof- Riba- Pegylated interferon | Active comparator | Drug: Sofosbuvir, Drug: Ribavirin, Drug: Pegylated-interferon alfa-2aSofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months |
| Sof- Olysio | Active comparator | Drug: Sofosbuvir, Drug: SimeprevirSofosbuvir and simeprevir for 3 months. |
| Sof- Dacla | Active comparator | Drug: Sofosbuvir, Drug: DaclatasvirSofosbuvir and Daclatasvir for 3 months. |
| Harvony | Active comparator | Drug: Sofosbuvir and LedipasvirSofosbuvir and ledipasvir for 3 months |
| Ritaprevir, paritaprevir, ombetasvir | Active comparator | Drug: Ritaprevir, paritaprevir, ombetasvirQuerevo for 3 months |
| Salvage therapy | Active comparator | Drug: Salvage therapysofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • HCV infection
Key exclusion criteria (6 listed)
- • Child score > 12
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SofosbuvirAlso: sovaldi , mpiviropackSofosbuvir 400 mg daily. | Drug | Sof- Dacla, Sof- Olysio, Sof- Riba- Pegylated interferon, Sof-Riba |
| RibavirinAlso: Rebetol, RibaRibavirin 1000-1200 mg daily | Drug | Sof- Riba- Pegylated interferon, Sof-Riba |
| Pegylated-interferon alfa-2aAlso: peginteron, pegasysPegylated interferon alfa-2a once weekly for 3 months | Drug | Sof- Riba- Pegylated interferon |
| SimeprevirAlso: OlysioOlysio once daily. | Drug | Sof- Olysio |
| DaclatasvirAlso: Daklatasvir, DaklaDakla once daily for three months. | Drug | Sof- Dacla |
| Ritaprevir, paritaprevir, ombetasvirAlso: querevoQuerevo for three months | Drug | Ritaprevir, paritaprevir, ombetasvir |
| Sofosbuvir and LedipasvirAlso: HarvonyOnce daily for three months | Drug | Harvony |
| Salvage therapyAlso: Sofosbuvir,simeprevir, daclatasvir, ribavirin or sofosbuvir and querevothree months in repeated treatment failure | Drug | Salvage therapy |
Primary outcome
Number of patients with sustained virological response.
Time frame: 2 months
The number of patients achieving SVR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Derived from this study: PubMed 32356185Said 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.
- Derived from this study: PubMed 29535545Ahmed 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asem Elfert, Prof study chair
Tanta university hospital
Lobna Abo ALi, Ass Prof study chair
Tanta university hospital
Sabry Abou Saif, Ass Prof study chair
Tanta university hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a in people with Hepatitis C, run by Tanta University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with sustained virological response. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02992457, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.