NCT02932293

Triple Combination DAAs for Treating HCV GT1b Subjects

Triple Combination DAAs for Ultra Short Duration Therapy for HCV Genotype 1b in Chinese (SODAPI II Study)

• Status: Withdrawn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

Summary

There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60 mg) in this study but the treatment duration may be different depending on patients' response to the antiviral therapy and whether patients have liver cirrhosis. If patients have no cirrhosis and the HCV viral load on day 2 is \<500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4 weeks. If patients have cirrhosis and the HCV viral load on day 2 is \<500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment duration will be 8 weeks.

Conditions

• Chronic Hepatitis C Infection

Interventions

Type	Name	Description
DRUG	SOF+DCV+SMV	Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-10-13
• Last updated: 2017-05-12

Locations

1 site across 1 country: Hong Kong