Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6
NCT ID: NCT02480166
Last Updated: 2017-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2015-06-30
2016-10-31
Brief Summary
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1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6
2. 12-week treatment of SOF/LED for all other HCV-6 populations
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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8 weeks SOF/LED
Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
8 weeks SOF/LED
Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
12 weeks SOF/LED
Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
12 weeks SOF/LED
Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
Interventions
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8 weeks SOF/LED
Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
12 weeks SOF/LED
Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6
3. Selected to start on treatment by their treating providers
4. Willing and able to provide informed consent
5. Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments
6. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline
7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
8. Lactating females must agree to discontinue nursing before the study drug is administered
Exclusion Criteria
2. Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Stanford University
OTHER
Responsible Party
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Mindie H. Nguyen
Associate Professor of Medicine
Principal Investigators
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Mindie H Nguyen, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University Medical Center
Palo Alto, California, United States
San Jose Gastroenterology
San Jose, California, United States
Liver and Digestive Consultants
Houston, Texas, United States
Digestive Health Associates
Plano, Texas, United States
Countries
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References
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Lawitz E, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 Aug 15;369(7):678-9. doi: 10.1056/NEJMc1307641. No abstract available.
Lam KD, Trinh HN, Do ST, Nguyen TT, Garcia RT, Nguyen T, Phan QQ, Nguyen HA, Nguyen KK, Nguyen LH, Nguyen MH. Randomized controlled trial of pegylated interferon-alfa 2a and ribavirin in treatment-naive chronic hepatitis C genotype 6. Hepatology. 2010 Nov;52(5):1573-80. doi: 10.1002/hep.23889.
Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, Nahass R, Ghalib R, Gitlin N, Herring R, Lalezari J, Younes ZH, Pockros PJ, Di Bisceglie AM, Arora S, Subramanian GM, Zhu Y, Dvory-Sobol H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Sulkowski M, Kwo P; ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17;370(16):1483-93. doi: 10.1056/NEJMoa1316366. Epub 2014 Apr 11.
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.
Chao DT, Abe K, Nguyen MH. Systematic review: epidemiology of hepatitis C genotype 6 and its management. Aliment Pharmacol Ther. 2011 Aug;34(3):286-96. doi: 10.1111/j.1365-2036.2011.04714.x. Epub 2011 May 29.
Other Identifiers
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33196
Identifier Type: -
Identifier Source: org_study_id