Glecaprevir/Pibrentasvir Real-world Study in China

• Conditions: Chronic Hepatitis c
• Interventions: Drug: Glecaprevir/Pibrentasvir

• Registration Number: NCT03941821
• Lead Sponsor: Tongji Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-06
• Last Update Submitted: 2019-05-06
• Study First Posted: 2019-05-08
• Last Update Posted: 2019-05-08
• Study Start: 2019-06-30
• Primary Completion: 2021-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• >18 years old
• Meet the standard of Glecaprevir/Pibrentasvir treatment

Exclusion Criteria

• Patients have contraindications to Glecaprevir/Pibrentasvir
• Pregnancy or lactation
• Malignancy
• Decompensatory cirrhosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
G/P treatment	Glecaprevir/Pibrentasvir	Chronic hepatitis C patients who will recieve Glecaprevir/Pibrentasvir treatment

Primary Outcome Measures

Name	Time	Method
SVR 12	12 weeks after Glecaprevir/Pibrentasvir treatments	The effectiveness of Glecaprevir/Pibrentasvir treatments and SVR rate 12 weeks after Glecaprevir/Pibrentasvir treatments
progression of Chronic liver disease	5 years after Glecaprevir/Pibrentasvir treatments	Incidence of liver disease progression (such as cirrhosis, decompensation of liver function, liver cancer, liver transplantation, or liver related death)

Secondary Outcome Measures

Name	Time	Method
long term outcome	5 years	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
HRQOL	5 years	To evaluate the impact of DAAs treatment on health-related quality of life (HRQOL) and health status of CHC patients