drugset / Trial / NCT02932293
Triple Combination DAAs for Treating HCV GT1b Subjects
Phase 2
Withdrawn
Humanity and Health Research Centre
Beijing 302 Hospital · collabEmory University · collabUniversity of Maryland · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-12
- Primary completion
- 2017-12
- Completion
- 2017-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daclatasvir | Small molecule | 60 mg | Oral |
| Subject | Simeprevir | Small molecule | 150 mg | Oral |
| Subject | Sofosbuvir | Small molecule | 400 mg | Oral |