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出境医 / 临床实验 / Glecaprevir/Pibrentasvir Real-world Study in China

Glecaprevir/Pibrentasvir Real-world Study in China

Study Description
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

Condition or disease Intervention/treatment
Chronic Hepatitis c Drug: Glecaprevir/Pibrentasvir

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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : June 30, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
G/P treatment
Chronic hepatitis C patients who will recieve Glecaprevir/Pibrentasvir treatment
 Drug: Glecaprevir/Pibrentasvir
Chronic hepatitis C patients will be given Glecaprevir/Pibrentasvir treatment
Other Name: Mavyret
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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)


Secondary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
Serum, urine and whole blood will be restored in central lab

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ning Qin, PHD,MD +8602783662391 qning@vip.sina.com
Contact: Guang Chen, Physcian +8602783663604 widechain@163.com

Sponsors and Collaborators
Tongji Hospital
Investigators
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Study Chair: Qin Ning, PHD,MD Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College HUST
Tracking Information
First Submitted Date May 6, 2019
First Posted Date May 8, 2019
Last Update Posted Date May 8, 2019
Estimated Study Start Date June 30, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2019)
  • 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
  • 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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 6, 2019)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Glecaprevir/Pibrentasvir Real-world Study in China
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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum, urine and whole blood will be restored in central lab
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
Condition Chronic Hepatitis c
Intervention Drug: Glecaprevir/Pibrentasvir
Chronic hepatitis C patients will be given Glecaprevir/Pibrentasvir treatment
Other Name: Mavyret
Study Groups/Cohorts G/P treatment
Chronic hepatitis C patients who will recieve Glecaprevir/Pibrentasvir treatment
Intervention: Drug: Glecaprevir/Pibrentasvir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 6, 2019) 		800
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2022
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ning Qin, PHD,MD +8602783662391 qning@vip.sina.com
Contact: Guang Chen, Physcian +8602783663604 widechain@163.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03941821
Other Study ID Numbers G/P RWS China
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Tongji Hospital
Study Sponsor Tongji Hospital
Collaborators Not Provided
Investigators
Study Chair: Qin Ning, PHD,MD Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College HUST
PRS Account Tongji Hospital
Verification Date May 2019

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