Chronic Hepatitis C Virus InfectionPhase 2/3NCT04387526
Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4
A Phase 2/3 study testing (SOF and DCV) and (SOF, DCV, and RBV) in people with Chronic Hepatitis C Virus Infection, run by Beni-Suef University.
Trial summary
This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4. 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 and DCV) and (SOF, DCV, and RBV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 946 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 31 May 2017
- Phase
- Phase 2/3
- 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
- Non-cirrhotic treatment-naïve participants
- FIB-4 < 3.25
- albumin > 3.5
- total bilirubin < 1.2 mg/dl
- international normalized ratio (INR) < 1.2
- platelet count > 150,000 mm3.
- experienced participants who had previously failed treatment with peg-IFN-α-/RBV, SOF/peg-IFN-α +RBV, or SOF/SMV
- Naïve cirrhotic participants were confirmed by ultrasonographic features of cirrhosis
Who cannot join
- liver disease of non-HCV etiology
- hepatitis B or human immune-deficiency virus (HIV) infection
- poorly controlled diabetic (HbA1C > 9) participants
- hepatocellular carcinoma
- a history of extra-hepatic malignancy within 5 years prior to the study
- pregnant or breast feeding
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- renal disease; serum creatinine > 2.5 mg/dl or eGFR < 30 ml/min
- evidence of hepatic decompensation; INR > 1.7, serum albumin < 2.8 g/dl, total bilirubin > 3 mg/dl
- blood picture abnormalities such as anemia (hemoglobin concentration of 10 g/dl or less) and thrombocytopenia (platelet count < 50,000 cells/mm3)
- major severe illnesses such as congestive heart failure and respiratory failure.
About this study
Official title: Efficacy and Safety of Sofosbuvir Plus Daclatasvir With or Without Ribavirin: Large Real-life Results of Patients With Chronic Hepatitis C Genotype 4
This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.
Read the detailed description
Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks.
SOF dose was 400 mg/day given orally DCV was given in a dose of 60 mg/day, orally. RBV was given as oral tablets in the morning and in the evening based on patient's weight and tolerability (starting dose 600 mg/day to reach 1200 mg/day.
- Conditions
- Chronic Hepatitis C Virus Infection
- Being tested
- (SOF and DCV), (SOF, DCV, and RBV)
- Keywords
- Sofosbuvir, Daclatasvir, Ribavirin, HCV GT 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(SOF and DCV)Drug
Also called Daklinza is a trade name of daclatasvir, Sovaldi is a trade name of sofosbuvir
(SOF, DCV, and RBV)Drug
Also called Daklinza is a trade name of daclatasvir, Sovaldi is a trade name of sofosbuvir
| Study group | Role | What they receive |
|---|---|---|
| SOF/DCV | Active comparator | Easy to treat arm: Participants were treated with a dual therapy (SOF and DCV) for 12 weeks.
This arm included non-cirrhotic treatment-naïve patients Receives: Drug: (SOF and DCV) |
| SOF/DCV/RBV + Cirrhosis | Active comparator | This difficult-to-treat arm included 111 cirrhotic participants who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks. Receives: Drug: (SOF, DCV, and RBV) |
| SOF/DCV/RBV + Non-Cirrhosis | Active comparator | This difficult-to-treat arm included treatment-experienced non-cirrhotic participants (77 participants) who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks. Receives: Drug: (SOF, DCV, and 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
SVR12 was 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: up for 12 weeks after planned End of Treatment (EOT).
Secondary outcomes (2)
Percentage of Participants With Viral relapse
Viral relapse was HCV RNA level ≤ 15 IU/ml at EOT, but detectable HCV RNA level > 15 IU/ml 12 weeks after planned EOT.
Measured: 12 weeks after last dose
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with HCV RNA greater than 15 IU/ml
Measured: up tp 24 weeks
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 Apr 2016
- Primary completion31 May 2017
- Study completion31 May 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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 946 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
- NCT04387526
- Sponsor's protocol ID
- SOF-DCV-RBV
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 15 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-Gabaar M, Zanaty MI, Ramadan M. Efficacy and safety of sofosbuvir plus daclatasvir with or without ribavirin: large real-life results of patients with chronic hepatitis C genotype 4. Hepatol Int. 2018 Jul;12(4):348-355. doi: 10.1007/s12072-018-9868-8. Epub 2018 May 12.
PubMed 29754329
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sofosbuvir Plus Daclatasvir With or Without Ribavirin: Large Real-life Results of Patients With Chronic Hepatitis C Genotype 4
- ClinicalTrials.gov ID
- NCT04387526
- Acronym / sponsor ID
- SOF-DCV-RBV
- Conditions
- Chronic Hepatitis C Virus Infection
- Keywords
- Sofosbuvir, Daclatasvir, Ribavirin, HCV GT 4
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 946 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 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.
This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.
Detailed description
Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks.
SOF dose was 400 mg/day given orally DCV was given in a dose of 60 mg/day, orally. RBV was given as oral tablets in the morning and in the evening based on patient's weight and tolerability (starting dose 600 mg/day to reach 1200 mg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SOF/DCV | Active comparator | Drug: (SOF and DCV)Easy to treat arm: Participants were treated with a dual therapy (SOF and DCV) for 12 weeks. This arm included non-cirrhotic treatment-naïve patients |
| SOF/DCV/RBV + Cirrhosis | Active comparator | Drug: (SOF, DCV, and RBV)This difficult-to-treat arm included 111 cirrhotic participants who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks. |
| SOF/DCV/RBV + Non-Cirrhosis | Active comparator | Drug: (SOF, DCV, and RBV)This difficult-to-treat arm included treatment-experienced non-cirrhotic participants (77 participants) who were treated with a triple therapy (SOF, DCV, and RBV) 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 (8 listed)
- Non-cirrhotic treatment-naïve participants
- FIB-4 < 3.25
- albumin > 3.5
- total bilirubin < 1.2 mg/dl
- international normalized ratio (INR) < 1.2
Key exclusion criteria (10 listed)
- liver disease of non-HCV etiology
- hepatitis B or human immune-deficiency virus (HIV) infection
- poorly controlled diabetic (HbA1C > 9) participants
- hepatocellular carcinoma
- a history of extra-hepatic malignancy within 5 years prior to the study
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 and DCV)Also: Daklinza is a trade name of daclatasvir, Sovaldi is a trade name of sofosbuvir | Drug | SOF/DCV |
| (SOF, DCV, and RBV)Also: Daklinza is a trade name of daclatasvir, Sovaldi is a trade name of sofosbuvir | Drug | SOF/DCV/RBV + Cirrhosis, SOF/DCV/RBV + Non-Cirrhosis |
Primary outcome
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12
Time frame: 12 weeks after last dose
SVR12 was 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: up for 12 weeks after planned End of Treatment (EOT).
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
2 secondary outcomes
Percentage of Participants With Viral relapse
Time frame: 12 weeks after last dose
Percentage of Participants With On-treatment Virologic Failure
Time frame: up tp 24 weeks
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 15 May 2020.
- Results publication: PubMed 29754329Abdel-Moneim A, Aboud A, Abdel-Gabaar M, Zanaty MI, Ramadan M. Efficacy and safety of sofosbuvir plus daclatasvir with or without ribavirin: large real-life results of patients with chronic hepatitis C genotype 4. Hepatol Int. 2018 Jul;12(4):348-355. doi: 10.1007/s12072-018-9868-8. Epub 2018 May 12.
- This link describes the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian patients infected with HCV GT4.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 2/3 study testing (SOF and DCV) and (SOF, DCV, and RBV) 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 8 inclusion and 10 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 15 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 SVR12 (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 NCT04387526, 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 15 May 2020.