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Real-world Effectiveness and Safety of Treatment With Direct Antiviral Agents (DAAs) in Patients With Chronic Hepatitis C and Cirrhosis in Southern Area of China

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Blood-Borne Infections+14

+ Chronic Disease

+ Communicable Diseases

Over 18 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2019
See protocol details

Summary

Principal SponsorThird Affiliated Hospital, Sun Yat-Sen University
Study ContactShuang C Lin, ProfessorMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 30, 2019

Actual date on which the first participant was enrolled.

This is a multi-center, open-label clinical study. This study was aimed to assess the real-world effectiveness and safety of treatment with listed DAAs in patients with CHC and cirrhosis in Southern area of China. The primary objectives of this study is as follows: To access the effectiveness and safety of 12-week/24-week treatment with listed DAAs in patients with CHC and cirrhosis in real-world clinical practice in Southern area of China. The proportion of participants with SVR12(Undetectable HCV RNA at 12 weeks after treatment completion RNA:Hepatitis C virus ribonucleic acid) was evaluated. This study aims to enroll 30 patients with CHC and cirrhosis in each treatment group. Patients with CHC and cirrhosis who fulfills the indication of antiviral therapy will be administered with DAAs treatment. After 12-week/2-week treatment, all the patients will be followed up for 12 weeks.

Official TitleReal-world Effectiveness and Safety of Treatment With Direct Antiviral Agents (DAAs) in Patients With Chronic Hepatitis C and Cirrhosis in Southern Area of China
NCT03887637
Principal SponsorThird Affiliated Hospital, Sun Yat-Sen University
Study ContactShuang C Lin, ProfessorMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesHepatitisHepatitis, ChronicHepatitis, Viral, HumanHepatitis CInfectionsLiver DiseasesPathologic ProcessesRNA Virus InfectionsPathological Conditions, Signs and SymptomsVirus DiseasesFlaviviridae InfectionsHepatitis C, ChronicDisease Attributes

Criteria

8 inclusion criteria required to participate
Male and female subjects with age >18 years old.
HCV RNA ≥1×103IU/mL
Genotype 1-6 HCV infection.
Confirmed CHC defined as: (1)Confirmed HCV infection more than 6 months at baseline, including anti-HCV positive or HCV RNA positive for at least 6 months; (2)Confirmed HCV infection by liver biopsy one year before baseline.
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15 exclusion criteria prevent from participating
History of clinically significant medical condition associated with other chronic liver disease (including hemochromatosis, autoimmune hepatitis, Wilson's disease, α1-antitrypsin deficiency, alcoholic liver disease, drug-induced liver injury).
Stomach disorder that could interfere with the absorption of the study drug.
Serious or active medical or psychiatric illness. If the participant has received more than 12 months of treatment and the condition is stable, or the participant does not need any medicine during the previous 12 months, the participant is allowed to enrollment.
Uncontrolled serious cardiovascular disease (such as ventricular tachyarrhythmia, myocardial infarction, angina or coronary disease); or uncontrolled hypertension (systolic pressure ≥160mmHg and/or diastolic pressure ≥100mmHg); or clinically relevant ECG abnormalities.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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