Glecaprevir/Pibrentasvir Real-world Study in China

NCT ID: NCT03941821

Last Updated: 2019-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-30

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Chronic Hepatitis c

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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G/P treatment

Chronic hepatitis C patients who will recieve Glecaprevir/Pibrentasvir treatment

Glecaprevir/Pibrentasvir

Intervention Type DRUG

Chronic hepatitis C patients will be given Glecaprevir/Pibrentasvir treatment

Interventions

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Glecaprevir/Pibrentasvir

Chronic hepatitis C patients will be given Glecaprevir/Pibrentasvir treatment

Intervention Type DRUG

Other Intervention Names

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Mavyret

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qin Ning, PHD,MD

Role: STUDY_CHAIR

Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College HUST

Central Contacts

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Ning Qin, PHD,MD

Role: CONTACT

+8602783662391

Guang Chen, Physcian

Role: CONTACT

+8602783663604

Other Identifiers

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G/P RWS China

Identifier Type: -

Identifier Source: org_study_id

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