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The purpose of this study is to evaluate the efficacy and safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Danoprevir, Ritonavir, Peg-IFN,RBV | Experimental | Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danoprevir | Drug | Danoprevir (DNV)administered orally 100mg BID for 12 weeks; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 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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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31608213 | Derived | Wei L, Shang J, Ma Y, Xu X, Huang Y, Guan Y, Duan Z, Zhang W, Gao Z, Zhang M, Li J, Jia J, Yang Y, Wen X, Wang M, Jia Z, Ning B, Chen Y, Qi Y, Du J, Jiang J, Tong L, Xie Y, Wu JJ. Efficacy and Safety of 12-week Interferon-based Danoprevir Regimen in Patients with Genotype 1 Chronic Hepatitis C. J Clin Transl Hepatol. 2019 Sep 28;7(3):221-225. doi: 10.14218/JCTH.2019.00018. Epub 2019 Jul 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Danoprevir, Ritonavir, Peg-IFN,RBV | Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks. Danoprevir: Danoprevir (DNV)administered orally 100mg BID for 12 weeks; Ritonavir: Ritonavir administered orally 100mg BID for 12 weeks; peginterferon alfa-2a: PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks; RBV: RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Danoprevir, Ritonavir, Peg-IFN,RBV | Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks. Danoprevir: Danoprevir (DNV)administered orally 100mg BID for 12 weeks; Ritonavir: Ritonavir administered orally 100mg BID for 12 weeks; peginterferon alfa-2a: PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks; RBV: RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks. |
| 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 | Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | Posted | Count of Participants | Participants | 12 weeks |
|
24 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 | Danoprevir, Ritonavir, Peg-IFN,RBV | Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks. Danoprevir: Danoprevir (DNV)administered orally 100mg BID for 12 weeks; Ritonavir: Ritonavir administered orally 100mg BID for 12 weeks; peginterferon alfa-2a: PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks; RBV: RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 21, 2017 | Jan 26, 2021 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 16, 2017 | Feb 28, 2021 | Prot_001.pdf |
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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 |
|---|---|
| C553752 | danoprevir |
| D019438 | Ritonavir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Ritonavir | Drug | Ritonavir administered orally 100mg BID for 12 weeks; |
|
| peginterferon alfa-2a | Drug | PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks; |
|
|
| RBV | Drug | RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks. |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Asia | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 141 |
| 5 |
| 141 |
| 76 |
| 141 |
| Ventricular tachyarrhythmia | Cardiac disorders | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | Systematic Assessment |
|
| Transient ischemic attack | Metabolism and nutrition disorders | Systematic Assessment |
|
| Acquired digital fibrokeratoma | Eye disorders | Systematic Assessment |
|
| Fever | Infections and infestations | 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 |