Chronic Hepatitis C Virus InfectionPhase 2NCT04385407
Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients
A Phase 2 study testing Sofosbuvir + Simeprevir + Ribavirin in people with Chronic Hepatitis C Virus Infection, run by Beni-Suef University.
Trial summary
A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus SMV (12 weeks). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C Virus Infection
- What is being tested?
- Sofosbuvir + Simeprevir + Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jul 2016
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with plasma HCV RNA level >10,000 IU/L for the two groups.
- Treatment-experienced patients in group 1 were those who had previously failed treatment with classical peg-IFN/RBV therapy.
- Treatment-experienced patients in group 2 were those who had previously failed treatment with SOF/RBV
Who cannot join
- coinfected with hepatitis B virus or human immunodeficiency virus infection,
- any cause of liver disease other than HCV GT4 infection;
- liver decompensation,
- hepatocellular carcinoma,
- major severe illness, such as renal failure, congestive heart failure, thyroid dysfunction, respiratory failure, autoimmune disease and poorly controlled diabetes (HbA1C >9)
- Participants with blood picture abnormalities, such as anemia (hemoglobin concentration of 10 g/or less) and thrombocytopenia (platelet count <50,000 cells/mm3)
About this study
Official title: Sofosbuvir in Combination With Ribavirin or Simeprevir: Real-life Study of Patients With Hepatitis C Genotype 4
A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus SMV (12 weeks).
Read the detailed description
A total of 201 participants, treatment-naïve and experienced, with chronic HCV GT4 infection were allocated into two groups based on the type of the regimen used. All eligible participants were treated orally with SOF plus daily oral weight-based RBV (24 weeks; group 1), or SOF plus daily oral SMV (12 weeks; group 2).
- Conditions
- Chronic Hepatitis C Virus Infection
- Being tested
- Sofosbuvir + Simeprevir + Ribavirin
- Keywords
- Egyptian patients, HCV GT4, Naive, Ribavirin, Simeprevir, Sofosbuvir, Experinced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir + Simeprevir + RibavirinDrug
Also called Olysio is a trade name of simeprevir, Sovaldi is a trade name of sofosbuvir
| Study group | Role | What they receive |
|---|---|---|
| SOF + RBV (Naive) | Active comparator | For treatment-naive participants, SOF was given in a dose of 400 mg/day + RBV was given orally in the morning and in the evening (total daily dose was based on body weight:<75 kg, 1000 mg; >75 kg, 1200 mg). Receives: Drug: Sofosbuvir + Simeprevir + Ribavirin |
| SOF + RBV (Experienced) | Active comparator | For treatment-experienced participants, SOF was given in a dose of 400 mg/day + RBV was given orally in the morning and in the evening (total daily dose was based on body weight:<75 kg, 1000 mg; >75 kg, 1200 mg). Receives: Drug: Sofosbuvir + Simeprevir + Ribavirin |
| SOF + SMV (Naive) | Active comparator | For treatment-naive participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule. Receives: Drug: Sofosbuvir + Simeprevir + Ribavirin |
| SOF + SMV (Expereined) | Active comparator | For treatment-experienced participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule. Receives: Drug: Sofosbuvir + Simeprevir + Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With HCV 12
HCV 12 is HCV RNA level <15 IU/mL at 12 weeks after planned end of treatment (EOT).
Measured: 12 weeks after last dose
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation administered the drugs of the study.
A serious adverse event (SAE) is an event that results in death, life-threatening, participant hospitalization, or disability/incapacity
Measured: up for 12 weeks after planned EOT.
Secondary outcomes (2)
Percentage of Participants With Virologic relapse
Viral relapse was HCV RNA level <15 IU/mL at EOT, but >15 IU/mL levels through 12 weeks after planned EOT
Measured: 12 weeks after the last dose
Percentage of Participants With Virologic null response
Virologic null response is defined as HCV RNA >15 IU/mL levels throughout the entire treatment period
Measured: 24 or 36 weeks stating from the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study startApr 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abdel-Gabbar, Ph.D, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385407
- Sponsor's protocol ID
- SOF-SMV-RBV
- Status last verified
- May 2020
- First submitted
- 9 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty MI, Elbary AAA, Ramadan M. Sofosbuvir in combination with ribavirin or simeprevir: real-life study of patients with hepatitis C genotype 4. Ann Gastroenterol. 2019 Jan-Feb;32(1):93-98. doi: 10.20524/aog.2018.0327. Epub 2018 Nov 24.
PubMed 30598598
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sofosbuvir in Combination With Ribavirin or Simeprevir: Real-life Study of Patients With Hepatitis C Genotype 4
- ClinicalTrials.gov ID
- NCT04385407
- Acronym / sponsor ID
- SOF-SMV-RBV
- Conditions
- Chronic Hepatitis C Virus Infection
- Keywords
- Egyptian patients, HCV GT4, Naive, Ribavirin, Simeprevir, Sofosbuvir, Experinced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 May 2020 (actual)
- 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.
A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus SMV (12 weeks).
Detailed description
A total of 201 participants, treatment-naïve and experienced, with chronic HCV GT4 infection were allocated into two groups based on the type of the regimen used. All eligible participants were treated orally with SOF plus daily oral weight-based RBV (24 weeks; group 1), or SOF plus daily oral SMV (12 weeks; group 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SOF + RBV (Naive) | Active comparator | Drug: Sofosbuvir + Simeprevir + RibavirinFor treatment-naive participants, SOF was given in a dose of 400 mg/day + RBV was given orally in the morning and in the evening (total daily dose was based on body weight:<75 kg, 1000 mg; >75 kg, 1200 mg). |
| SOF + RBV (Experienced) | Active comparator | Drug: Sofosbuvir + Simeprevir + RibavirinFor treatment-experienced participants, SOF was given in a dose of 400 mg/day + RBV was given orally in the morning and in the evening (total daily dose was based on body weight:<75 kg, 1000 mg; >75 kg, 1200 mg). |
| SOF + SMV (Naive) | Active comparator | Drug: Sofosbuvir + Simeprevir + RibavirinFor treatment-naive participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule. |
| SOF + SMV (Expereined) | Active comparator | Drug: Sofosbuvir + Simeprevir + RibavirinFor treatment-experienced participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants with plasma HCV RNA level >10,000 IU/L for the two groups.
- Treatment-experienced patients in group 1 were those who had previously failed treatment with classical peg-IFN/RBV therapy.
- Treatment-experienced patients in group 2 were those who had previously failed treatment with SOF/RBV
Key exclusion criteria (6 listed)
- coinfected with hepatitis B virus or human immunodeficiency virus infection,
- any cause of liver disease other than HCV GT4 infection;
- liver decompensation,
- hepatocellular carcinoma,
- major severe illness, such as renal failure, congestive heart failure, thyroid dysfunction, respiratory failure, autoimmune disease and poorly controlled diabetes (HbA1C >9)
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 |
|---|---|---|
| Sofosbuvir + Simeprevir + RibavirinAlso: Olysio is a trade name of simeprevir, Sovaldi is a trade name of sofosbuvir | Drug | SOF + RBV (Experienced), SOF + RBV (Naive), SOF + SMV (Expereined), SOF + SMV (Naive) |
Primary outcome
Percentage of Participants With HCV 12
Time frame: 12 weeks after last dose
HCV 12 is HCV RNA level <15 IU/mL at 12 weeks after planned end of treatment (EOT).
Number of Participants With Adverse Events
Time frame: up for 12 weeks after planned EOT.
An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation administered the drugs of the study. A serious adverse event (SAE) is an event that results in death, life-threatening, participant hospitalization, or disability/incapacity
2 secondary outcomes
Percentage of Participants With Virologic relapse
Time frame: 12 weeks after the last dose
Percentage of Participants With Virologic null response
Time frame: 24 or 36 weeks stating from the first dose
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 12 May 2020.
- Results publication: PubMed 30598598Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty MI, Elbary AAA, Ramadan M. Sofosbuvir in combination with ribavirin or simeprevir: real-life study of patients with hepatitis C genotype 4. Ann Gastroenterol. 2019 Jan-Feb;32(1):93-98. doi: 10.20524/aog.2018.0327. Epub 2018 Nov 24.
- This link describes the effectiveness and safety of two regimens sofosbuvir (SOF) in combination with either ribavirin (RBV) or simeprevir (SMV) in chronic hepatitis C (CHC) genotype (GT) 4 patients in Egypt.Link provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sofosbuvir + Simeprevir + Ribavirin in people with Chronic Hepatitis C Virus Infection, run by Beni-Suef University.
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 3 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of Participants With HCV 12 (time frame: 12 weeks after last dose). The study lists 2 primary outcomes in all. 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 NCT04385407, which also lists 1 linked publication.
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 12 May 2020.