Glecaprevir/Pibrentasvir Real-world Study in China
May 6, 2019 updated by: Tongji Hospital
The Efficacy, Safety and Long-term Prognosis of Glecaprevir/Pibrentasvir in the Treatment of Chronic Hepatitis C Patients in China--A Real-world Study
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with chronic hepatitis C who will received Glecaprevir/Pibrentasvir treatment and meet the inclusion and exclusion criteria above
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
G/P treatment
Chronic hepatitis C patients who will recieve Glecaprevir/Pibrentasvir treatment
|
Chronic hepatitis C patients will be given Glecaprevir/Pibrentasvir treatment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SVR 12
Time Frame: 12 weeks after Glecaprevir/Pibrentasvir treatments
|
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
Time Frame: 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)
|
5 years after Glecaprevir/Pibrentasvir treatments
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
long term outcome
Time Frame: 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
|
5 years
|
|
HRQOL
Time Frame: 5 years
|
To evaluate the impact of DAAs treatment on health-related quality of life (HRQOL) and health status of CHC patients
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Qin Ning, PHD,MD, Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College HUST
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 30, 2019
Primary Completion (Anticipated)
June 30, 2021
Study Completion (Anticipated)
June 30, 2022
Study Registration Dates
First Submitted
May 6, 2019
First Submitted That Met QC Criteria
May 6, 2019
First Posted (Actual)
May 8, 2019
Study Record Updates
Last Update Posted (Actual)
May 8, 2019
Last Update Submitted That Met QC Criteria
May 6, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G/P RWS China
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.