CompletedPhase 2

Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease

United States95 participantsStarted 2017-06-27

Plain-language summary

The primary objectives of this study are to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are on dialysis for ESRD.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Chronic HCV infected genotype 1, 2 (Taiwan only), 4, 5, or 6 male and nonpregnant/ nonlactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV coinfection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimens for ≥8 weeks prior to screening. NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

What they're measuring

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

Timeframe: Posttreatment Week 12

Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

Timeframe: First dose date up to Week 24

Trial details

NCT IDNCT03036839

SponsorGilead Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-22

Results submitted2019-11-15

View on ClinicalTrials.gov More Hepatitis C Virus Infection trials