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

NCT04952207 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2021-07-07

No results posted yet for this study

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.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Direct-acting antiviral agents

The initial DAA treatment and its dose for all patients is determined by the infectionist or hepatologist based on the clinical diagnosis and treatment routine. The administration dose in the instructions for use for current DAAs marketed in China Mainland unnecessary to combine with any IFN is shown but not limited as follows: Sofosbuvir, Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir, Daclatasvir, Asunaprevir, Elbasvir/Grazoprevir, Sofosbuvir/Velpatasvir and Ledipasvir/Sofosbuvir.

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Tigermed Consulting Co., Ltd

    collaborator INDUSTRY

  • Qing XIe

    lead OTHER

Principal Investigators

  • Qing Xie, MD · Director of Department of Infectious Disease, Rui Jin Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-06
Primary Completion
2021-07-31
Completion
2021-08-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04952207 on ClinicalTrials.gov