NCT04952207

Effectiveness and Safety of Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C

Effectiveness and Safety of Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C: Multi-center, Prospective, Observational Real-world Study in EASTERN China
Qing XIe·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Hepatitis C, Chronic
Drug/Device/Intervention
Direct-acting antiviral agents
Study type
Observational
Intervention type
drug
Sponsor & location
Primary sponsor
Qing XIe
Funder
Ruijin Hospital
Location
Changzhou,Nanjing,Nanjing,Nanjing,Suzhou,Wuxi,Shanghai,Shanghai,Shanghai,Jiaxing,Ningbo, China
Timeline & enrollment
Phase
N/A
Start date
Mar 06, 2019
End date
Aug 31, 2021
Enrollment
300 participants
Primary outcome

SVR12 rate of DAA

Summary

Clinical trials evaluating DAA have shown excellent rates of SVR and good safety profiles in
 patients with CHC infection. Real world data from TARGET, TRIO, IFI, DHCR, DALTON-C, as well
 as those cohorts from Japan, Taiwan and Korea further confirmed clinical trial findings of
 DAA in routine practice where populations are more complex. However, these populations are
 different from Chinese for different host and virus characteristics which limit the
 applicability of results to local practice.
 
 As DAA launched in China since 2017, the availability of INF free DAA treatment will likely
 lead to better treatment outcome in routine practice, but there are currently no data
 available to test the hypothesis.
 
 In clinical practice, the uptake of DAA regimen will depend on a combination of physician
 preference, patient's characteristics and drug access. This study will also identify how
 these three variables affect DAA regimen uptake.
 
 This study to 1) characterize pts receiving IFN free DAA regimens, 2) represent common
 practice in China, 3) describe outcome of various INF free DAA therapy, and 4) confirm
 registration study results.

ICD-10 classifications
Chronic viral hepatitis CAcute hepatitis CChronic hepatitis, unspecifiedChronic viral hepatitisChronic viral hepatitis, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04952207
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04952207 through Pure Global AI's free database. This phase not specified trial is sponsored by Qing XIe and is currently Recruiting. The study focuses on Hepatitis C, Chronic. Target enrollment is 300 participants.

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