NCT04382339|CompletedPhase 1/2DMC
Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4
HCV
Effectiveness of Sofosbuvir/Pegylated-interferon Plus Ribavirin in Treatment of Hepatitis C Virus Genotype 4 Patients
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Sponsor study identifier
interventional
99
0 countries
N/A
Study Start
March 2015
Actual (reported)Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2015
Actual (reported)November 2015
Actual (reported)November 2015
Actual (reported)May 6, 2020
Actual (reported)May 11, 2020
Actual (reported)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.
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
Screening until 30 days after last dose
Percentage of Participants With Viral relapse
12 weeks after last dose
Percentage of Participants With On-treatment Virologic Failure
up tp 24 weeks
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)
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)
SOF: block the hepatitis C NS5B protein. RBV: a nucleoside inhibitor PegINFα-2: chemically modified form of the standard interferon that treats hepatitis C
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Mohammed Abdel-Gabbar, Ass. Prof
Biochemistry Dep., Faculty of Science, Beni-Suef University, P.O. Box 52621
99 participants (actual enrollment reported by the registry).
First Submitted
May 6, 2020
First Posted
May 11, 2020
Study Start
March 2015
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Last Updated
May 11, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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