A Phase 2/3 interventional study of Sofosbuvir and Daclatasvir in Chronic Hepatitis C Infection, sponsored by Humanity and Health Research Centre. Completed at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-19.
Sponsored by Humanity and Health Research Centre · Phase 2/3, Interventional, and Treatment
For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is a burning need for the development of pan-oral interferon-free regimen. The investigators examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis patients with chronic G1b infection.
Chinese genotype 1b HCV treatment-experienced cirrhotic patients are recruited and treated with 12 weeks sofosbuvir 400 mg daily plus daclatasvir 60 mg daily. At baseline, liver stiffness measurement (LSM) using transient elastography (FibroScan®) is used to assess liver fibrosis and the single nucleotide polymorphism ofinterferon-λ 3 (IL-28, rs12979860, C or T) and IFLN4 (ss469415590, TT or ΔG) is determined. Serial measurement of plasma HCV RNA levels are performed with the use of the COBAS TaqMan real-time assay (Roche version 2.0), at baseline, Day 2,4 and 7, week 2,4 and 12, post-treatment week 12. The primary efficacy end point is a sustained virologic response 12 weeks after the end of treatment (SVR12).
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 106 is below the median of 120 across 4,200 interventional studies indexed under Infections.
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Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.
Drug: Sofosbuvir · Drug: Daclatasvir
Sofosbuvir 400 mg tablet administered once daily
Also known as: GS-7977
Daclatasvir 60mg tablet administered once daily
Also known as: BMS-790052
Proportion of participants with sustained virologic response 12 weeks after the end of treatment (SVR12)
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) (15 IU/ml) 12 weeks following the last dose of study drug
Time frame: Post treatment Week 12
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Humanity and Health Research Centre