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
1 other identifier
observational
800
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedStudy Start
First participant enrolled
June 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedMay 8, 2019
May 1, 2019
2 years
May 6, 2019
May 6, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
long term outcome
5 years
HRQOL
5 years
Study Arms (1)
G/P treatment
Chronic hepatitis C patients who will recieve Glecaprevir/Pibrentasvir treatment
Interventions
Chronic hepatitis C patients will be given Glecaprevir/Pibrentasvir treatment
Eligibility Criteria
Patients with chronic hepatitis C who will received Glecaprevir/Pibrentasvir treatment and meet the inclusion and exclusion criteria above
You may qualify if:
- \>18 years old
- Meet the standard of Glecaprevir/Pibrentasvir treatment
You may not qualify if:
- Patients have contraindications to Glecaprevir/Pibrentasvir
- Pregnancy or lactation
- Malignancy
- Decompensatory cirrhosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Biospecimen
Serum, urine and whole blood will be restored in central lab
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Qin Ning, PHD,MD
Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College HUST
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2019
First Posted
May 8, 2019
Study Start
June 30, 2019
Primary Completion
June 30, 2021
Study Completion
June 30, 2022
Last Updated
May 8, 2019
Record last verified: 2019-05