Glecaprevir/Pibrentasvir Real-world Study in China

The Efficacy, Safety and Long-term Prognosis of Glecaprevir/Pibrentasvir in the Treatment of Chronic Hepatitis C Patients in China--A Real-world Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03941821

Enrollment

800

Registered

2019-05-08

Start date

2019-06-30

Completion date

2022-06-30

Last updated

2019-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis c

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.

Interventions

DRUGGlecaprevir/Pibrentasvir

Chronic hepatitis C patients will be given Glecaprevir/Pibrentasvir treatment

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Contacts

Primary ContactNing Qin, PHD,MD

qning@vip.sina.com+8602783662391

Backup ContactGuang Chen, Physcian

widechain@163.com+8602783663604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026