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The purpose of this study is to assess the efficacy and safety of Ravidasvir in combination with Danoprevir/r and ribavirin(RBV) by sustain virologic response 12 (SVR12), in treatment-naive, non-cirrhotic, chronic hepatitis C genotype 1 infected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Ravidasvir + Danoprevir + Ritonavir + Ribavirin |
|
| Placebo Group | Placebo Comparator | Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ravidasvir | Drug | Ravidasvir 200mg tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants achieving sustained Virologic response 12 weeks after EOT | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks after cessation of therapy | Post treatment Week 12 |
| Adverse events leading to permanent discontinuation of study drug | baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants achieving sustained Virologic response 4 weeks after EOT | SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks after cessation of therapy | Post treatment Week 4 |
| Percentage of Participants achieving sustained Virologic response 24 weeks after EOT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yahong Chen, Master | Ascletis Pharmaceuticals Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's hospital | Beijing | Beijing Municipality | 100044 | China |
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| Danoprevir | Drug | Danoprevir 100mg tablet administered orally twice daily |
|
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| Ritonavir | Drug | Ritonavir 100mg tablet administered orally twice daily |
|
| Ribavirin 100 MG | Drug | Ribavirin tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(<75kg = 1000mg and ≥75kg = 1200mg) |
|
| Ravidasvir Placebo | Drug | Ravidasvir Placebo tablet administered orally once daily |
|
| Danoprevir Placebo | Drug | Danoprevir Placebo tablet administered orally twice daily |
|
| Ritonavir Placebo | Drug | Ritonavir Placebo tablet administered orally twice daily |
|
| Ribavirin Placebo | Drug | Ribavirin Placebo tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(<75kg = 5 tablets and ≥75kg = 6 tablets) |
|
SVR24 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 24 weeks after cessation of therapy |
| Post treatment Week 24 |
| Quatitation change of HCV RNA compared to baseline after treatment | Baseline to week 1 |
| Percentage of participants with viral breakthrough | Viral breakthrough was defined as HCV RNA ≥LLOQ after having previously had HCV RNA< LLOQ while receiving treatment, confirmed with 2 consecutive values | Baseline to week 12 |
| Percentage of participants with viral relapse | Viral relapse was defined as HCV RNA ≥LLOQ during the post treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values. | End of treatment to post-treatment week 24 |
| ID | Term |
|---|---|
| C000621711 | ravidasvir |
| C553752 | danoprevir |
| D019438 | Ritonavir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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