Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
1 other identifier
interventional
255
1 country
4
Brief Summary
The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2015
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2015
CompletedFirst Posted
Study publicly available on registry
July 1, 2015
CompletedStudy Start
First participant enrolled
September 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2017
CompletedResults Posted
Study results publicly available
December 14, 2017
CompletedNovember 16, 2018
November 1, 2017
1.2 years
June 27, 2015
November 9, 2017
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Posttreatment Week 12
Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)
12 weeks
Secondary Outcomes (2)
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
Percentage of Participants With Overall Virologic Failure
Up to Posttreatment Week 24
Study Arms (7)
LDV/SOF 8 wk TN (Cohort 1, Group 1)
EXPERIMENTALLDV/SOF for 8 weeks (treatment-naive (TN))
LDV/SOF+RBV 8 wk TN (Cohort 1, Group 2)
EXPERIMENTALLDV/SOF+RBV for 8 weeks (treatment-naive)
LDV/SOF 12 wk TN (Cohort 1, Group 3)
EXPERIMENTALLDV/SOF for 12 weeks (treatment-naive)
LDV/SOF+RBV 12 wk TN (Cohort 1, Group 4)
EXPERIMENTALLDV/SOF+RBV for 12 weeks (treatment-naive)
LDV/SOF+RBV 12 wk TE (Cohort 2)
EXPERIMENTALTreatment-experienced (TE) participants who completed treatment in Gilead sponsored study GS-US-334-0138 or in Cohort 1 of this study and did not achieve SVR12 will receive LDV/SOF+RBV for 12 weeks.
LDV/SOF 12 wk TE (Cohort 3, Group 1)
EXPERIMENTALLDV/SOF for 12 weeks (treatment-experienced)
LDV/SOF+RBV 12 wk TE (Cohort 3, Group 2)
EXPERIMENTALLDV/SOF+RBV for 12 weeks (treatment-experienced)
Interventions
90/400 mg FDC tablet administered orally once daily
Tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent
- Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
- HCV genotype 4 at screening
- HCV treatment naive or prior participation in this study or study GS-US-334-0138 (Cohorts 1 and 2 only)
- Cohort 3 only: HCV treatment-experienced (previously received therapy for HCV infection with an interferon (IFN)-containing regimen, with or without RBV and/or an HCV NS3/NS4A protease inhibitor (PI)
- Body mass index (BMI) ≥ 18 kg/m\^2
- Screening laboratory values within defined thresholds
- Use of effective protocol-approved contraception methods
You may not qualify if:
- History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Pregnant or nursing females or male with pregnant female partner
- Clinically-relevant drug or alcohol abuse within 12 months of screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (4)
Unknown Facility
Al Mansurah, Egypt
Unknown Facility
Cairo, 11559, Egypt
Unknown Facility
Cairo, 11796, Egypt
Unknown Facility
Shibīn al Kawm, Egypt
Related Publications (2)
Shiha G, Waked I, Soliman R, Abdelrazek W, Hassany M, Fouad R, et al. Ledipasvir/sofosbuvir for 8 or 12 weeks with or without ribavirin in HCV genotype 4 patients in Egypt. [Abstract OP158]. Asian Pacific Association for the Study of the Liver (APASL); 2017 15-19 February; Shanghai, China
RESULTShiha G, Esmat G, Hassany M, Soliman R, Elbasiony M, Fouad R, Elsharkawy A, Hammad R, Abdel-Razek W, Zakareya T, Kersey K, Massetto B, Osinusi A, Lu S, Brainard DM, McHutchison JG, Waked I, Doss W. Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt. Gut. 2019 Apr;68(4):721-728. doi: 10.1136/gutjnl-2017-315906. Epub 2018 Apr 17.
PMID: 29666174DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2015
First Posted
July 1, 2015
Study Start
September 7, 2015
Primary Completion
November 11, 2016
Study Completion
February 4, 2017
Last Updated
November 16, 2018
Results First Posted
December 14, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.