- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02487030
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
October 19, 2018 updated by: Gilead Sciences
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
255
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt, 11796
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Cairo, Egypt, 11559
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Mansourah, Egypt
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Shibin Al Kawm, Egypt
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LDV/SOF 8 wk TN (Cohort 1, Group 1)
LDV/SOF for 8 weeks (treatment-naive (TN))
|
90/400 mg FDC tablet administered orally once daily
Other Names:
|
Experimental: LDV/SOF+RBV 8 wk TN (Cohort 1, Group 2)
LDV/SOF+RBV for 8 weeks (treatment-naive)
|
90/400 mg FDC tablet administered orally once daily
Other Names:
Tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
|
Experimental: LDV/SOF 12 wk TN (Cohort 1, Group 3)
LDV/SOF for 12 weeks (treatment-naive)
|
90/400 mg FDC tablet administered orally once daily
Other Names:
|
Experimental: LDV/SOF+RBV 12 wk TN (Cohort 1, Group 4)
LDV/SOF+RBV for 12 weeks (treatment-naive)
|
90/400 mg FDC tablet administered orally once daily
Other Names:
Tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
|
Experimental: LDV/SOF+RBV 12 wk TE (Cohort 2)
Treatment-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.
|
90/400 mg FDC tablet administered orally once daily
Other Names:
Tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
|
Experimental: LDV/SOF 12 wk TE (Cohort 3, Group 1)
LDV/SOF for 12 weeks (treatment-experienced)
|
90/400 mg FDC tablet administered orally once daily
Other Names:
|
Experimental: LDV/SOF+RBV 12 wk TE (Cohort 3, Group 2)
LDV/SOF+RBV for 12 weeks (treatment-experienced)
|
90/400 mg FDC tablet administered orally once daily
Other Names:
Tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
|
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)
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time Frame: Posttreatment Weeks 4 and 24
|
SVR4 and SVR24 were defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of study drug, respectively.
|
Posttreatment Weeks 4 and 24
|
Percentage of Participants With Overall Virologic Failure
Time Frame: Up to Posttreatment Week 24
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Virologic failure was defined as
|
Up to Posttreatment Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
- Shiha 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2015
Primary Completion (Actual)
November 11, 2016
Study Completion (Actual)
February 4, 2017
Study Registration Dates
First Submitted
June 27, 2015
First Submitted That Met QC Criteria
June 27, 2015
First Posted (Estimate)
July 1, 2015
Study Record Updates
Last Update Posted (Actual)
November 16, 2018
Last Update Submitted That Met QC Criteria
October 19, 2018
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Disease Attributes
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Infections
- Communicable Diseases
- Hepatitis
- Hepatitis C
- Anti-Infective Agents
- Antiviral Agents
- Sofosbuvir
- Ledipasvir, sofosbuvir drug combination
- Ledipasvir
Other Study ID Numbers
- GS-US-337-1643
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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