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To evaluate the efficacy, adverse effect, short - and long-term outcomes of Glecaprevir/Pibrentasvir for the treatment of chronic hepatitis C (non-cirrhotic or compensatory cirrhosis)in China through a real-world study
This study is a multi-center, prospective, real-world study, aiming to investigate the use of Glecaprevir/Pibrentasvir in routine clinical management of chronic hepatitis C patients and evaluate its effectiveness and safety across a heterogeneous population in China.Approximately 800 patients will take part in this study, 20 sites will be included which distribute in China's major cities, thus each site will enroll 40 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G/P treatment | Chronic hepatitis C patients who will recieve Glecaprevir/Pibrentasvir treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glecaprevir/Pibrentasvir | Drug | Chronic hepatitis C patients will be given Glecaprevir/Pibrentasvir treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| SVR 12 | The effectiveness of Glecaprevir/Pibrentasvir treatments and SVR rate 12 weeks after Glecaprevir/Pibrentasvir treatments | 12 weeks after Glecaprevir/Pibrentasvir treatments |
| progression of Chronic liver disease | Incidence of liver disease progression (such as cirrhosis, decompensation of liver function, liver cancer, liver transplantation, or liver related death) | 5 years after Glecaprevir/Pibrentasvir treatments |
| Measure | Description | Time Frame |
|---|---|---|
| long term outcome | Assess the duration of the virologic response (5 years) in CHC patients with daas-based regimens who have achieved a sustained virologic response (svr12/24) at 12 or 24 weeks after the end of treatment and analyze the factors influencing the recurrence of HCV | 5 years |
| HRQOL |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic hepatitis C who will received Glecaprevir/Pibrentasvir treatment and meet the inclusion and exclusion criteria above
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Qin, PHD,MD | Contact | +8602783662391 | qning@vip.sina.com | |
| Guang Chen, Physcian | Contact | +8602783663604 | widechain@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qin Ning, PHD,MD | Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College HUST | Study Chair |
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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 |
|---|---|
| C000654128 | glecaprevir and pibrentasvir |
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Serum, urine and whole blood will be restored in central lab
To evaluate the impact of DAAs treatment on health-related quality of life (HRQOL) and health status of CHC patients |
| 5 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 |