Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency
NCT ID: NCT01958281
Last Updated: 2018-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2013-10-07
2017-10-19
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
SEQUENTIAL
TREATMENT
NONE
Study Groups
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SOF 200 mg + RBV 200 mg (Cohort 1)
Participants with genotype 1 or 3 HCV infection will receive SOF 200 mg (2 × 100 mg tablets) plus RBV once daily for 24 weeks.
SOF
Tablet(s) administered orally once daily
RBV
200 mg tablet administered orally once daily
SOF 400 mg + RBV 200 mg (Cohort 2)
Participants with genotype 1 or 3 HCV infection will receive SOF 400 mg (4 × 100 mg tablets or 1 × 400 mg tablet) plus RBV once daily for 24 weeks.
SOF
Tablet(s) administered orally once daily
RBV
200 mg tablet administered orally once daily
LDV/SOF (Cohort 3)
Participants with genotype 1 or 4 HCV infection will receive LDV/SOF once daily for 12 weeks.
LDV/SOF
90/400 mg fixed-dose combination (FDC) tablet administered orally once daily
Interventions
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SOF
Tablet(s) administered orally once daily
RBV
200 mg tablet administered orally once daily
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
* Cohort 3: chronic genotype 1 or 4 HCV infection
* HCV RNA ≥ 10\^4 IU/mL at screening
* Screening labs within defined thresholds
* Cirrhosis determination at screening
Exclusion Criteria
* Prior null response to pegylated interferon (Peg-IFN)+RBV therapy (Cohorts 1 and 2) or for individuals with cirrhosis, prior treatment failure with IFN-based therapy not resulting from treatment intolerance (Cohort 3)
* Current of prior history of hepatic decompensation
* Infection with hepatitis B virus (HBV) or HIV
* History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with individual's treatment and/or adherence to 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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San Francisco, California, United States
Miami, Florida, United States
Chicago, Illinois, United States
Detroit, Michigan, United States
Rochester, New York, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Grafton, Auckland, New Zealand
Christchurch, , New Zealand
San Juan, , Puerto Rico
Countries
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References
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Gane EJ, Robson RA, Bonacini M, Maliakkal B, Kirby B, Liu L, et al. Safety, Antiviral Efficacy, and Pharmacokinetics of Sofosbuvir in Patients With Severe Renal Impairment [Poster 966]. The 65th Annual meeting of the American Association for the Study of Liver Diseases: The Liver Meeting (AASLD); 2014 November 07-11; Boston, MA.
Martin P, Gane E, Ortiz-Lasanta G, Liu L, Sajwani K, Kirby B, et al. Safety and Efficacy of Treatment With Daily Sofosbuvir 400 mg + Ribavirin 200 mg for 24 Weeks in Genotype 1 or 3 HCV-Infected Patients With Severe Renal Impairment [Poster 1128]. American Association for the Study of Liver Diseases (AASLD); 2015 November 13-17; San Francisco, CA.
Lawitz E, Landis CS, Maliakkal BJ, Bonacini M, Ortiz-Lasanta G, Zhang J, et al. Safety and Efficacy of Treatment with Once- Daily Ledipasvir/Sofosbuvir (90/400 mg) for 12 Weeks in Genotype 1 HCV-Infected Patients with Severe Renal Impairment [Abstract 1587]. The Liver Meeting® 2017 - The 68th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2017 20-24 October; Washington, D. C.
Lawitz E, Landis CS, Flamm SL, Bonacini M, Ortiz-Lasanta G, Huang J, Zhang J, Kirby BJ, De-Oertel S, Hyland RH, Osinusi AO, Brainard DM, Robson R, Maliakkal BJ, Gordon SC, Gane EJ. Sofosbuvir plus ribavirin and sofosbuvir plus ledipasvir in patients with genotype 1 or 3 hepatitis C virus and severe renal impairment: a multicentre, phase 2b, non-randomised, open-label study. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):918-926. doi: 10.1016/S2468-1253(19)30417-0. Epub 2020 Jun 10.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Document Type: Study Protocol: Amendment 4
Document Type: Statistical Analysis Plan: Statistical Analysis Plan for Cohorts 1 and 2
Document Type: Statistical Analysis Plan: Statistical Analysis Plan for Cohort 3
Other Identifiers
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2013-002897-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-334-0154
Identifier Type: -
Identifier Source: org_study_id
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