Glecaprevir/Pibrentasvir Real-world Study in China

Chronic Hepatitis c Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03941821
• Other study ID #: G/P RWS China
• Status: Not yet recruiting
• Start date: June 30, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2019
• Source: Tongji Hospital
• Contact: Ning Qin, PHD,MD
• Phone: +8602783662391
• Email: qning[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Glecaprevir/Pibrentasvir
Chronic hepatitis C patients will be given Glecaprevir/Pibrentasvir treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR 12	The effectiveness of Glecaprevir/Pibrentasvir treatments and SVR rate 12 weeks after Glecaprevir/Pibrentasvir treatments	12 weeks after Glecaprevir/Pibrentasvir treatments
Primary	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
Secondary	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
Secondary	HRQOL	To evaluate the impact of DAAs treatment on health-related quality of life (HRQOL) and health status of CHC patients	5 years