Chronic Hepatitis C Virus InfectionPhase 1/2NCT04387539
ٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin and HCV Genotype 4-infected Egyptian Experienced Participants
A Phase 1/2 study testing SOF/SMV/DCV/RBV in people with Chronic Hepatitis C Virus Infection, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV) 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?
- SOF/SMV/DCV/RBV
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 31 Oct 2017
- Phase
- Phase 1/2
- 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
- Experienced Egyptian participants with HCV GT4 infection who had failed prior DAA treatments [SOF/DCV or SOF/SMV or SOF/pegylated interferon/RBV or SOF/RBV]
- Fibrosis-4 score in non-cirrhotic participants is <1.45-3.25: (None or moderate fibrosis)
- Fibrosis-4 score in cirrhotic participants is >3.25: (Advanced fibrosis or cirrhosis)
Who cannot join
- HCV coinfected with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- had any liver disease other than chronic HCV GT4 infection.
- had a history of liver decompensation
- serum a-fetoprotein (AFP) > 100 ng/ml
- evidence of hepatocellular carcinoma
- major severe illness such as respiratory, renal, heart failure or autoimmune disease
- non-compliance with treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Sofosbuvir-based Quadruple Regimen is Highly Effective in HCV Type 4-infected Egyptian Patients With DAA Treatment Failure
Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)
Read the detailed description
Experienced participants, who had chronic infection with HCV GT4 , and failed prior DAA treatments, SOF/DCV (71/92) or SOF/SMV (15/92) or SOF/pegylated interferon/RBV (2/92) or SOF/RBV (4/92) were enrolled in the current study.
In the present study, the regimen used was designed by the combination of triple DAAs with different mechanisms of action and non-overlapping resistance profiles, SOF/SMV/DCV, plus RBV.
- Conditions
- Chronic Hepatitis C Virus Infection
- Being tested
- SOF/SMV/DCV/RBV
- Keywords
- Chronic HCV GT4, Sofosbuvir, Simeprevir, Daclatasvir, Ribavirin, Experienced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOF/SMV/DCV/RBVDrug
Also called Olysio is a trade name of simeprevir, Sovaldi is a trade name of sofosbuvir, Daklinza is a trade name of daclatasvir
SOF was given orally at a dose of 400 mg/day DCV was given orally at a dose of 60 mg/day SMV was given orally at a dose of 150 mg/day. RBV was given in a total daily oral dose of 600 mg/day up to 1,200 mg/day according to the participant's weight and tolerability.
| Study group | Role | What they receive |
|---|---|---|
| Non-Cirrhotic | Active comparator | SOF plus DCV/SMV/RBV regimen was administered to Egyptian non-cirrhotic experienced HCV GT4 participants for 12 weeks Receives: Drug: SOF/SMV/DCV/RBV |
| Cirrhotic | Active comparator | SOF plus DCV/SMV/RBV regimen was administered to Egyptian cirrhotic experienced HCV GT4 participants for 12 weeks Receives: Drug: SOF/SMV/DCV/RBV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/m 12 weeks after the last dose of drugs.
Measured: 12 weeks after last dose
Number of Participants With Adverse Events in Each Treatment Arm
An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation after administering a pharmaceutical drugs Serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity
Measured: Screening up to 12 weeks after last dose
Secondary outcomes (1)
Percentage of Participants With Viral relapse
Viral relapse was HCV RNA level undetectable at End of Treatment (EOT) (≤ 15 IU/ml), but detectable HCV RNA ( > 15 IU/ml) levels 12 weeks after planned EOT.
Measured: Up to 12 weeks after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Mar 2017
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 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
- Investigators
- Mohammed Abdel-Gabbar, Ass. Prof, Principal investigator, Biochemistry Dep., Faculty of Science, Beni-Suef University, P.O. Box 52621
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387539
- Sponsor's protocol ID
- SOF/SMV/DCV/RBV
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 14 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, Ramadan M. A sofosbuvir-based quadruple regimen is highly effective in HCV type 4-infected Egyptian patients with DAA treatment failure. J Hepatol. 2018 Jun;68(6):1313-1315. doi: 10.1016/j.jhep.2018.03.010. Epub 2018 Apr 3. No abstract available.
PubMed 29625827
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sofosbuvir-based Quadruple Regimen is Highly Effective in HCV Type 4-infected Egyptian Patients With DAA Treatment Failure
- ClinicalTrials.gov ID
- NCT04387539
- Acronym / sponsor ID
- SOF/SMV/DCV/RBV
- Conditions
- Chronic Hepatitis C Virus Infection
- Keywords
- Chronic HCV GT4, Sofosbuvir, Simeprevir, Daclatasvir, Ribavirin, Experienced
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 14 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.
Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)
Detailed description
Experienced participants, who had chronic infection with HCV GT4 , and failed prior DAA treatments, SOF/DCV (71/92) or SOF/SMV (15/92) or SOF/pegylated interferon/RBV (2/92) or SOF/RBV (4/92) were enrolled in the current study.
In the present study, the regimen used was designed by the combination of triple DAAs with different mechanisms of action and non-overlapping resistance profiles, SOF/SMV/DCV, plus RBV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Cirrhotic | Active comparator | Drug: SOF/SMV/DCV/RBVSOF plus DCV/SMV/RBV regimen was administered to Egyptian non-cirrhotic experienced HCV GT4 participants for 12 weeks |
| Cirrhotic | Active comparator | Drug: SOF/SMV/DCV/RBVSOF plus DCV/SMV/RBV regimen was administered to Egyptian cirrhotic experienced HCV GT4 participants for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Experienced Egyptian participants with HCV GT4 infection who had failed prior DAA treatments [SOF/DCV or SOF/SMV or SOF/pegylated interferon/RBV or SOF/RBV]
- Fibrosis-4 score in non-cirrhotic participants is <1.45-3.25: (None or moderate fibrosis)
- Fibrosis-4 score in cirrhotic participants is >3.25: (Advanced fibrosis or cirrhosis)
Key exclusion criteria (7 listed)
- HCV coinfected with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- had any liver disease other than chronic HCV GT4 infection.
- had a history of liver decompensation
- serum a-fetoprotein (AFP) > 100 ng/ml
- evidence of hepatocellular carcinoma
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 |
|---|---|---|
| SOF/SMV/DCV/RBVAlso: Olysio is a trade name of simeprevir, Sovaldi is a trade name of sofosbuvir, Daklinza is a trade name of daclatasvirSOF was given orally at a dose of 400 mg/day DCV was given orally at a dose of 60 mg/day SMV was given orally at a dose of 150 mg/day. RBV was given in a total daily oral dose of 600 mg/day up to 1,200 mg/day according to the participant's weight and tolerability. | Drug | Cirrhotic, Non-Cirrhotic |
Primary outcome
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
Time frame: 12 weeks after last dose
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/m 12 weeks after the last dose of drugs.
Number of Participants With Adverse Events in Each Treatment Arm
Time frame: Screening up to 12 weeks after last dose
An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation after administering a pharmaceutical drugs Serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity
1 secondary outcome
Percentage of Participants With Viral relapse
Time frame: Up to 12 weeks after last 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 14 May 2020.
- Results publication: PubMed 29625827Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty MI, Ramadan M. A sofosbuvir-based quadruple regimen is highly effective in HCV type 4-infected Egyptian patients with DAA treatment failure. J Hepatol. 2018 Jun;68(6):1313-1315. doi: 10.1016/j.jhep.2018.03.010. Epub 2018 Apr 3. No abstract available.
- This link shows the investigation performed in the retreatment with SOF plus DCV/SMV/RBV regimen in EgyptianHCV GT4 participantsLink 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.
Mohammed Abdel-Gabbar, Ass. Prof principal investigator
Biochemistry Dep., Faculty of Science, Beni-Suef University, P.O. Box 52621
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SOF/SMV/DCV/RBV in people with Chronic Hepatitis C Virus Infection, run by Beni-Suef University at 1 site 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 3 inclusion and 7 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 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm (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 NCT04387539, 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 14 May 2020.