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This is a multi-center, open-label clinical study. This study was aimed to assess the real-world effectiveness and safety of treatment with listed DAAs in patients with CHC and cirrhosis in Southern area of China.
This is a multi-center, open-label clinical study. This study was aimed to assess the real-world effectiveness and safety of treatment with listed DAAs in patients with CHC and cirrhosis in Southern area of China.
The primary objectives of this study is as follows:
To access the effectiveness and safety of 12-week/24-week treatment with listed DAAs in patients with CHC and cirrhosis in real-world clinical practice in Southern area of China. The proportion of participants with SVR12(Undetectable HCV RNA at 12 weeks after treatment completion RNA:Hepatitis C virus ribonucleic acid) was evaluated.
This study aims to enroll 30 patients with CHC and cirrhosis in each treatment group.
Patients with CHC and cirrhosis who fulfills the indication of antiviral therapy will be administered with DAAs treatment. After 12-week/2-week treatment, all the patients will be followed up for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Danoprevir Sodium triple therapy | DNV(Danoprevir Sodium)/PegIFNα(Peginterferon α-2a)/RBV(Ribavirin) : (1) DNV : 100mg (one tablet) orally twice daily for 12 weeks. (2) PegIFNα: 180ug subcutaneous infection on abdomen or thigh once a week for 12 weeks. (3) RBV: 500mg (5 tablets) orally twice daily for 12 weeks in patients weighing less than 75kg; 600mg (6 tablets) orally twice daily for 12 weeks in patients weighing ≥75kg. Dosing time: In the morning, participants will be instructed to take DNV and RBV with food or one hour after food. The drugs are not allowed to be cut or divided. The interval between DNV and RBV dosing time should be 12±2 hours. |
| |
| Sofosbuvir/ Velpatasvir therapy | Sofosbuvir/ Velpatasvir :500mg (two drugs in one tablet) orally once daily for 12 weeks. |
| |
| Ombitasvir/Paritaprevir therapy | Ombitasvir/Paritaprevir: Ombitasvir two tablets orally once daily for 12 weeks; Paritaprevir one tablet orally twice daily for 12 weeks. |
| |
| Grazoprevir/elbasvir therapy | Grazoprevir/elbasvir: 150mg (two drugs in one tablet) orally once daily for 12 weeks. |
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| Daclatasvir/Asunaprevir therapy | Daclatasvir (60mg)one tablet once daily and Asunaprevir (100mg)one tablet twice daily for 24weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAAs | Drug | Patients with CHC and cirrhosis who fulfills the indication of antiviral therapy will be administered with DAAs treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SVR(Sustained Virologic Response)12 | The proportion of participants with HCV RNA undetectable at 12weeks after treatment completion | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| RVR (Rapid Virological Response)4 | The proportion of participants with HCV RNA undetectable at 4 weeks after treatment | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female subjects with age >18 years old
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuang C Lin, Professor | Contact | 008613794365980 | linchaoshuang@126.com | |
| Wei W Deng, Student | Contact | 008613342811669 | 116536049@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Shuang C Lin, Professor | Third Sun Yat Sen | Principal Investigator |
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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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| Danoprevir Sodium/Sofosbuvir therapy | Danoprevir Sodium: 100mg (one tablet) orally twice daily for 12 weeks;Sofosbuvir:400mg (one tablet) orally once daily for 12 weeks. |
|
| 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 |