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Effectiveness and Safety of Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C - Trial NCT04952207

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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NCT04952207
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Trial Details
ClinicalTrials.gov โ€ข NCT04952207
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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

Study Focus

Hepatitis C, Chronic

Direct-acting antiviral agents

Observational

drug

Sponsor & Location

Qing XIe

Ruijin Hospital

Changzhou,Nanjing,Nanjing,Nanjing,Suzhou,Wuxi,Shanghai,Shanghai,Shanghai,Jiaxing,Ningbo, China

Timeline & Enrollment

N/A

Mar 06, 2019

Aug 31, 2021

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 C
Acute hepatitis C
Chronic hepatitis, unspecified
Chronic viral hepatitis
Chronic viral hepatitis, unspecified

Data Source

ClinicalTrials.gov

NCT04952207

Non-Device Trial