Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Danoprevir,Ritonavir, Peg-IFN,RBV | Experimental | Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danoprevir | Drug | Danoprevir (DNV) 100mg tablet administered orally twice 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 | 24 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Huoling Tang, PhD | Ascletis Pharmaceuticals Co., Ltd. | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Danoprevir,Ritonavir, Peg-IFN,RBV | Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks. Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily Ritonavir: Ritonavir 100mg tablet administered orally twice daily peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Danoprevir,Ritonavir, Peg-IFN,RBV | Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks. Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily Ritonavir: Ritonavir 100mg tablet administered orally twice daily peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) |
| 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 | 24 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Danoprevir,Ritonavir, Peg-IFN,RBV | Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks. Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily Ritonavir: Ritonavir 100mg tablet administered orally twice daily peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Ascletis Pharmaceuticals Co., Ltd | +86057185389732 | yicheng.zhao@ascletis.com |
Not provided
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C553752 | danoprevir |
| D019438 | Ritonavir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ritonavir | Drug | Ritonavir 100mg tablet administered orally twice daily |
|
| peginterferon alfa-2a | Drug | PegIFN subcutaneous injection at 180 mcg weekly |
|
|
| Ribavirin (RBV) | Drug | Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 1 |
| 70 |
| 70 |
| 70 |
| White blood cell decreased | Investigations | 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 |