CClinicalTrials.gg
Status unknownNCT03941821Updated May 8, 2019

Glecaprevir/Pibrentasvir Real-world Study in China

An observational study in Chronic Hepatitis c, sponsored by Tongji Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-08.

Sponsored by Tongji Hospital · Observational

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
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Study 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

Read the 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.

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Conditions studied

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In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's planned enrollment of 800 is above the median of 244 across 567 observational studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Inclusion criteria

  • >18 years old
  • Meet the standard of Glecaprevir/Pibrentasvir treatment

Exclusion criteria

Exclusion Criteria:

  • Patients have contraindications to Glecaprevir/Pibrentasvir
  • Pregnancy or lactation
  • Malignancy
  • Decompensatory cirrhosis
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • G/P treatment

    Chronic hepatitis C patients who will recieve Glecaprevir/Pibrentasvir treatment

    Drug: Glecaprevir/Pibrentasvir

Interventions

  • DrugGlecaprevir/Pibrentasvir

    Chronic hepatitis C patients will be given Glecaprevir/Pibrentasvir treatment

    Also known as: Mavyret

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What researchers measure

Primary outcomes

  1. SVR 12

    The effectiveness of Glecaprevir/Pibrentasvir treatments and SVR rate 12 weeks after Glecaprevir/Pibrentasvir treatments

    Time frame: 12 weeks after Glecaprevir/Pibrentasvir treatments

  2. 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)

    Time frame: 5 years after Glecaprevir/Pibrentasvir treatments

Secondary outcomes

  1. 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

    Time frame: 5 years

  2. HRQOL

    To evaluate the impact of DAAs treatment on health-related quality of life (HRQOL) and health status of CHC patients

    Time frame: 5 years

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03941821
Lead sponsor
Tongji Hospital
Responsible party
Sponsor
First posted
May 8, 2019
Start date
Jun 30, 2019 (estimated)
Primary completion
Jun 30, 2021 (estimated)
Completion
Jun 30, 2022 (estimated)
Last update
May 8, 2019

Study contacts

Ning Qin, PHD,MD
Contact
qning@vip.sina.com
+8602783662391
Guang Chen, Physcian
Contact
widechain@163.com
+8602783663604
Qin Ning, PHD,MD
study chair · Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College HUST

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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