NCT03794258

Triple or Quadruple Combination DAAs Treatment for Subjects With HCV GT 1b Infection

A Phase 2a, Open-label, Randomized Study of the Safety and Preliminary Efficacy of Triple or Quadruple Combination DAAs With Ultra-short Duration Therapy in Subjects With HCV Genotype 1b Infection (YANGTZE Study)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Humanity & Health Medical Group Limited · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2a, open-label, randomized study. The study is designed to test the hypothesis that the nucleoside inhibitor sofosbuvir combined with NS5A inhibitor daclatasvir and NS5B non-nucleoside inhibitor CDI-31244 with/without the protease inhibitor asunaprevir will result in high SVR rate with a shortened treatment duration (2 weeks) in non-cirrhotic HCV genotype 1b-infected subjects.

Conditions

• HCV Infection

Interventions

Type	Name	Description
DRUG	SOF+DCV+CDI-31244	Sofosbuvir (SOF) 400 mg administered orally once daily; Daclatasvir (DCV) 60 mg administered orally once daily; CDI-31244 400 mg administered orally once daily.
DRUG	SOF+DCV+CDI-31244+ASV	Sofosbuvir (SOF) 400 mg administered orally once daily; Daclatasvir (DCV) 60 mg administered orally once daily; CDI-31244 400 mg orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-04-15
• Completion: 2020-04-30
• First posted: 2019-01-07
• Last updated: 2020-05-07

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated drug study