Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
NCT ID: NCT01701401
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
870 participants
INTERVENTIONAL
2012-09-30
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LDV/SOF 12 weeks
LDV/SOF administered for 12 weeks
LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
LDV/SOF+RBV 12 weeks
LDV/SOF+RBV administered for 12 weeks.
LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
LDV/SOF 24 weeks
LDV/SOF administered for 24 weeks
LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
LDV/SOF+RBV 24 weeks
LDV/SOF+RBV administered for 24 weeks.
LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Interventions
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LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV treatment-naive
* HCV RNA \> 10,000 IU/mL at screening
* Cirrhosis determination; a liver biopsy may be required
* 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)
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with subject 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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Jenny Yang, Pharm D
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Birmingham, Alabama, United States
La Jolla, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Sacramento, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Englewood, Colorado, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Wellington, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Lutherville, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Rochester, Minnesota, United States
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Hillsborough, New Jersey, United States
Albuquerque, New Mexico, United States
Santa Fe, New Mexico, United States
Manhasset, New York, United States
New York, New York, United States
The Bronx, New York, United States
Asheville, North Carolina, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Fayetteville, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Fairfax, Virginia, United States
Falls Church, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
CHRU Lille, , France
Clichy, , France
Créteil, , France
La Tronche, , France
Lyon, , France
Marseille, , France
Nice, , France
Paris, , France
Berlin, , Germany
Cologne, , Germany
Düsseldorf, , Germany
Essen, , Germany
Frankfurt, , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
Hanover, , Germany
Mainz, , Germany
Bologna, , Italy
Brescia, , Italy
Milan, , Italy
Padua, , Italy
Palermo, , Italy
Roma, , Italy
San Giovanni Rotondo, , Italy
Torino, , Italy
San Juan, , Puerto Rico
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Santander, , Spain
Seville, , Spain
Birmingham, Wstmid, United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Plymouth, , United Kingdom
Countries
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References
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Grebely J, Mauss S, Brown A, Bronowicki JP, Puoti M, Wyles D, Natha M, Zhu Y, Yang J, Kreter B, Brainard DM, Yun C, Carr V, Dore GJ. Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin in Patients With Chronic HCV Genotype 1 Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ION Trials. Clin Infect Dis. 2016 Dec 1;63(11):1405-1411. doi: 10.1093/cid/ciw580. Epub 2016 Aug 23.
Younossi ZM, Elsheikh E, Stepanova M, Gerber L, Nader F, Stamm LM, Brainard DM, McHutchinson JG. Ledipasvir/sofosbuvir treatment of hepatitis C virus is associated with reduction in serum apolipoprotein levels. J Viral Hepat. 2015 Dec;22(12):977-82. doi: 10.1111/jvh.12448. Epub 2015 Aug 17.
Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Brau N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11.
Other Identifiers
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2012-003387-43
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-337-0102
Identifier Type: -
Identifier Source: org_study_id
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