Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease
NCT ID: NCT02301936
Last Updated: 2018-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2015-03-02
2016-04-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LDV/SOF 12 weeks
Treatment-naive or treatment-experienced participants without cirrhosis will receive LDV/SOF for 12 weeks.
LDV/SOF
90/400 mg fixed dose combination (FDC) tablet administered orally once daily
LDV/SOF 24 weeks
Treatment-experienced participants with cirrhosis will receive LDV/SOF for 24 weeks.
LDV/SOF
90/400 mg fixed dose combination (FDC) tablet administered orally once daily
Interventions
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LDV/SOF
90/400 mg fixed dose combination (FDC) tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA ≥ 1,000 IU/mL at screening
* Cirrhosis determination by transient elastography
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria
* Co-infection with HIV or hepatitis B virus (HBV)
* Current or prior history of clinical hepatic decompensation
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* History of clinically significant illness or any other medical disorder that may interfere with treatment, assessment or compliance with the protocol
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Lutherville, Maryland, United States
Countries
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Other Identifiers
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GS-US-337-1405
Identifier Type: -
Identifier Source: org_study_id
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