Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III
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ClinicalTrials.gov Identifier: NCT03020082 |
Recruitment Status :
Completed
First Posted : January 13, 2017
Results First Posted : March 23, 2021
Last Update Posted : March 23, 2021
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Condition or disease | Intervention/treatment | Phase |
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Chronic Hepatitis C | Drug: Danoprevir Drug: Ritonavir Drug: peginterferon alfa-2a Drug: RBV | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 141 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-centered, Open Label, Phase III Study on Efficacy, 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 |
Study Start Date : | June 2016 |
Actual Primary Completion Date : | May 2017 |
Actual Study Completion Date : | May 2017 |

Arm | Intervention/treatment |
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Experimental: 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.
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Drug: Danoprevir
Danoprevir (DNV)administered orally 100mg BID for 12 weeks;
Other Name: ASC08 Drug: Ritonavir Ritonavir administered orally 100mg BID for 12 weeks; Drug: peginterferon alfa-2a PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;
Other Name: Peg-IFN Drug: RBV RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.
Other Name: Ribasphere® |
- Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Willing and able to provide written informed consent
- Chronic HCV infection (≥ 6 months)
- Serum HCV RNA of ≥ 1 × 104 IU/mL are documented
- Hepatitis C virus GT1
- Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
- Non-cirrhosis patients: Non-cirrhosis is defined (1)Fibroscan defined as: ˂ 14.6 kPa during screening period, or liver biopsy determined 1 year before recruiting (Metavir score ˂ 3);(2) during screening period 9.6<Fibroscan indicator ≤12.9, liver biopsy need to confirm non-cirrhosis.
- Others as specified in the detailed protocol
Exclusion Criteria:
- Patients with Fibroscan detection value > 12.9 kPa, or histologic examination for liver cirrhosis patients
- Presence or history of non-hepatitis C chronic liver disease (e.g. HH, AIH, Wilson's disease, α1 antitrypsin deficiency, drug- or toxin-induced liver disease)
- History of liver cell cancer, or suspected hepatocellular carcinoma (HCC) patients before or during screening , or imaging studies found suspicious nodules, or AFP > 50 ng/mL
- Positive hepatitis A antibody,positive hepatitis B surface antigen,HIV antibody
- Presence or history of nervous system diseases and/or mental illness, inability to control oneself or express oneself.
- Patients with obvious cardiovascular dysfunction
- Pregnant or nursing female, nor unwilling to take reliable contraception
- Others as specified in the detailed protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020082
Study Director: | Huoling Tang, PhD | Ascletis Pharmaceuticals Co., Ltd. |
Documents provided by Ascletis Pharmaceuticals Co., Ltd.:
Responsible Party: | Ascletis Pharmaceuticals Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03020082 |
Other Study ID Numbers: |
ASC08201503 |
First Posted: | January 13, 2017 Key Record Dates |
Results First Posted: | March 23, 2021 |
Last Update Posted: | March 23, 2021 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Danoprevir non-cirrhotic Chinese HCV G1 SVR12 |
Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Ritonavir |
Peginterferon alfa-2a Ribavirin HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antimetabolites |