Chronic Hepatitis C Genotype 1b Clinical Trial
Official title:
Multicenter, Open-label, Phase II Safety and Efficacy Study of All-oral Combination Narlaprevir/Ritonavir and Daclatasvir Administered for 12 Weeks in Patients With Genotype 1b Chronic Hepatitis C
The purpose of this study is to confirm that combination of Narlaprevir, Ritonavir and Daclatasvir is safe and highly effective regimen in treatment-naїve patients with chronic hepatitis C (HCV) genotype 1b infection.
To evaluate effectiveness and safety of treatment with Narlaprevir, Ritonavir and Daclatasvir
combination will be selected 105 treatment-naїve patients with chronic HCV genotype 1b
without genetic variants coding for the NS5A-Y93 С/H/N/S and/or L31 F/M/V/I amino acid
substitutions, eligible as per protocol criteria.
Each patient will participate in the trial approximately up to 38 weeks:
- 2 weeks are expected for screening
- up to 12 weeks for treatment period
- 24 weeks for follow-up period
During treatment period all patient will receive equal drug combination.
Efficacy and safety parameters will be assessed as per primary and secondary endpoints. Also
Ctrough for Narlaprevir and Daclatasvir on day 14 will be evaluated as pharmacokinetic
objective.
The results of this study will provide new information about treatment of patients with
chronic hepatitis C genotype 1 with Narlaprevir/Ritonavir in combination with Daclatasvir
during 12 weeks.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03222167 -
Open-Label Efficacy and Safety Study of the Elbasvir/ Grazoprevir Fixed Dose Combination Patients With Chronic HCV GT1b
|
Phase 3 |