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The purpose of this study is to evaluate the efficacy, safety and tolerability of Ravidasvir (ASC16) in combination with Ritonavir-boosted Danoprevir(ASC08) and Ribavirin in treatment-naive no-cirrhotic Taiwanese patients who have chronic hepatitis C genotype1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ravidasvir,Danoprevir/r,RBV | Experimental | Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ravidasvir | Drug | Ravidasvir 200mg tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment | SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huoling Tang, PhD | Ascletis Pharmaceuticals Co., Ltd. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ravidasvir,Danoprevir/r,RBV | Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks. Ravidasvir: Ravidasvir 200mg tablet administered orally once daily Danoprevir: Danoprevir 100mg tablet administered orally twice daily Ritonavir: Ritonavir 100mg tablet administered orally twice daily Ribavirin: Ribavirin(RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)administered orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ravidasvir,Danoprevir/r,RBV | Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks. Ravidasvir: Ravidasvir 200mg tablet administered orally once daily Danoprevir: Danoprevir 100mg tablet administered orally twice daily Ritonavir: Ritonavir 100mg tablet administered orally twice daily Ribavirin: Ribavirin(RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)administered orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment | SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration. | Posted | Count of Participants | Participants | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ravidasvir,Danoprevir/r,RBV | Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks. Ravidasvir: Ravidasvir 200mg tablet administered orally once daily Danoprevir: Danoprevir 100mg tablet administered orally twice daily Ritonavir: Ritonavir 100mg tablet administered orally twice daily Ribavirin: Ribavirin(RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)administered orally |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Ascletis Pharmaceticals Co., Ltd | 86057187707910 | xin.li@ascletis.com |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000621711 | ravidasvir |
| C553752 | danoprevir |
| D019438 | Ritonavir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Danoprevir | Drug | Danoprevir 100mg tablet administered orally twice daily |
|
|
| Ritonavir | Drug | Ritonavir 100mg tablet administered orally twice daily |
|
| Ribavirin | Drug | Ribavirin(RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)administered orally |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 14 |
| 38 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Ascletis, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The study has been completed at all study sites for at least 3 years.
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |