Hepatitis C Virus InfectionPhase 1/2HCVNCT04382339
Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4
A Phase 1/2 study testing SOF/RBV/PegINFα-2 in people with Hepatitis C Virus Infection, run by Beni-Suef University.
Trial summary
This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- SOF/RBV/PegINFα-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Nov 2015
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study population consisted of treatment-naïve and treatment-experienced adults patients aged 20-65 with HCV RNA level > 10,000 IU/ml.
- Experienced participants included those with a prior relapse or a null response to PegINF/RBV therapy.
- -
Who cannot join
- HCV coinfected with hepatitis B virus (HBV)
- 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.
About this study
Official title: Effectiveness of Sofosbuvir/Pegylated-interferon Plus Ribavirin in Treatment of Hepatitis C Virus Genotype 4 Patients
This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants
Read the detailed description
Between March 2015 and November 2015, 99 participants (59 naïve and 40 experienced) infected with HCV GT4 were enrolled in the study. Eligible participants received daily oral 400 mg SOF ( (Sovaldi, Gilead Sciences, Inc., USA), RBV (Copegus, Roche, Europe) based on body weight: < 75 kg, 1000 mg; ≥75 kg, 1200 mg), the dose modified according to participants tolerability, plus 180 μg PegINFα-2 once weekly for 12 weeks.
Experienced participants included participants with a prior relapse or a null response to PegINF/RBV therapy.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- SOF/RBV/PegINFα-2
- Keywords
- HCV genotype 4, sofosbuvir, Peg-interferon α-2, ribavirin, Egyptian patients, Experinced, Naive
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOF/RBV/PegINFα-2Drug
SOF: block the hepatitis C NS5B protein. RBV: a nucleoside inhibitor PegINFα-2: chemically modified form of the standard interferon that treats hepatitis C
| Study group | Role | What they receive |
|---|---|---|
| Treatment-naive | Active comparator | Naive Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks
Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2) Receives: Drug: SOF/RBV/PegINFα-2 |
| Treatment-experienced | Active comparator | Experienced Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks
Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2) Receives: Drug: SOF/RBV/PegINFα-2 |
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) < 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 or i 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 until 30 days after last dose
Secondary outcomes (2)
Percentage of Participants With Viral relapse
Viral relapse was HCV RNA undetectable at EOT, but detectable HCV RNA > 15 IU/ml levels 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 posted11 May 2020
- Study startMar 2015
- Primary completionNov 2015
- Study completionNov 2015
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 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
- NCT04382339
- Sponsor's protocol ID
- SOF-PEG
- Acronym
- HCV
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 11 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, Abood A, Abdel-Gabaar M, Zanaty MI, Ramadan M. Effectiveness of sofosbuvir/pegylated-interferon plus ribavirin in treatment of hepatitis C virus genotype 4 patients. Clin Exp Hepatol. 2018 Sep;4(3):191-196. doi: 10.5114/ceh.2018.78123. Epub 2018 Sep 10.
PubMed 30324144
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sofosbuvir/Pegylated-interferon Plus Ribavirin in Treatment of Hepatitis C Virus Genotype 4 Patients
- ClinicalTrials.gov ID
- NCT04382339
- Acronym / sponsor ID
- HCV / SOF-PEG
- Conditions
- Hepatitis C Virus Infection
- Keywords
- HCV genotype 4, sofosbuvir, Peg-interferon α-2, ribavirin, Egyptian patients, Experinced, Naive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 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 assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants
Detailed description
Between March 2015 and November 2015, 99 participants (59 naïve and 40 experienced) infected with HCV GT4 were enrolled in the study. Eligible participants received daily oral 400 mg SOF ( (Sovaldi, Gilead Sciences, Inc., USA), RBV (Copegus, Roche, Europe) based on body weight: < 75 kg, 1000 mg; ≥75 kg, 1200 mg), the dose modified according to participants tolerability, plus 180 μg PegINFα-2 once weekly for 12 weeks.
Experienced participants included participants with a prior relapse or a null response to PegINF/RBV therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-naive | Active comparator | Drug: SOF/RBV/PegINFα-2Naive Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2) |
| Treatment-experienced | Active comparator | Drug: SOF/RBV/PegINFα-2Experienced Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The study population consisted of treatment-naïve and treatment-experienced adults patients aged 20-65 with HCV RNA level > 10,000 IU/ml.
- Experienced participants included those with a prior relapse or a null response to PegINF/RBV therapy.
- -
Key exclusion criteria (8 listed)
- HCV coinfected with hepatitis B virus (HBV)
- 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
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/RBV/PegINFα-2SOF: block the hepatitis C NS5B protein. RBV: a nucleoside inhibitor PegINFα-2: chemically modified form of the standard interferon that treats hepatitis C | Drug | Treatment-experienced, Treatment-naive |
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) < 15 IU/m 12 weeks after the last dose of drugs.
Number of Participants With Adverse Events in Each Treatment Arm
Time frame: Screening until 30 days after last dose
An adverse event (AE) is defined as any untoward medical occurrence in a participant or i 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 11 May 2020.
- Results publication: PubMed 30324144Abdel-Moneim A, Abood A, Abdel-Gabaar M, Zanaty MI, Ramadan M. Effectiveness of sofosbuvir/pegylated-interferon plus ribavirin in treatment of hepatitis C virus genotype 4 patients. Clin Exp Hepatol. 2018 Sep;4(3):191-196. doi: 10.5114/ceh.2018.78123. Epub 2018 Sep 10.
- The link clarify the effectiveness of sofosbuvir/pegylated-interferon plus ribavirin in treatment of hepatitis C virus genotype 4 patientsLink 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
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SOF/RBV/PegINFα-2 in people with 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 8 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 11 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 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 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 NCT04382339, 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 11 May 2020.