NCT04952207

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

2.4 years

First QC Date

June 24, 2021

Last Update Submit

July 4, 2021

Conditions

Hepatitis C, Chronic

Keywords

Chronic hepatitis CDirect-acting antiviral agentsSustained virological response

Outcome Measures

Primary Outcomes (1)

  • SVR12 rate of DAA

    Sustained virological response at 12 week; ie, HCV RNA \<15 IU/ ml at 12 weeks after the treatment with DAA regimen.

    12 weeks after the treatment with DAA regimen

Study Arms (1)

DAA Group

Chronic hepatitis C patients treated with DAA

Drug: Direct-acting antiviral agents

Interventions

Direct-acting antiviral agentsDRUG

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.

Also known as: daclatasvir, asunaprevir, ombitasvir, paritaprevir, dasabuvir, sofosbuvir, velpatasvir, ledipasvir, elbasvir, grazoprevir, danoprevir, glecaprevir, pibrentasvir, voxilaprevir
DAA Group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The primary objective of this study is to obtain the SVR12 rate of CHC patients in Eastern China. The previous study of Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine showed that the SVR12 rate was 0.988 (CI 95%: 0.952-1.0, Shanghai, China, Rui Jin Hospital, 26th APASL annual meeting, PO241). In this study, the estimated value of SVR is set to 95%, the bilateral significance level is 0.05 and the sampling error is 0.03. The estimated sample size is 225 as per the sample size calculation formula. Considering the patient withdrawal, this study is planned to collect 300 patients.

You may qualify if:

  • All Chronic hepatitis C patients to be treated with the DAAs approved by CFDA/NMPA
  • Age≥18 years

You may not qualify if:

  • Patients experienced with DAAs
  • Documented HCC, AFP\>500ng/ml
  • Unlikely to survive 1 year or inability to participate and follow up for the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Changzhou Third People's Hospital

Changzhou, Jiangsu, 213001, China

RECRUITING

The Second Hospital of Nanjing

Nanjing, Jiangsu, 210003, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

The Fifth People's Hospital of Suzhou

Suzhou, Jiangsu, 215007, China

RECRUITING

Wuxi No. 5 People's Hospital

Wuxi, Jiangsu, 214016, China

RECRUITING

Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201058, China

RECRUITING

The First Hospital of Jiaxing

Jiaxing, Zhejiang, 314000, China

RECRUITING

Hwa Mei Hospital

Ningbo, Zhejiang, 315010, China

RECRUITING

Related Publications (9)

  • Lu J, Zhou Y, Lin X, Jiang Y, Tian R, Zhang Y, Wu J, Zhang F, Zhang Y, Wang Y, Bi S. General epidemiological parameters of viral hepatitis A, B, C, and E in six regions of China: a cross-sectional study in 2007. PLoS One. 2009 Dec 24;4(12):e8467. doi: 10.1371/journal.pone.0008467.

    PMID: 20041146BACKGROUND

  • Chen YS, Li L, Cui FQ, Xing WG, Wang L, Jia ZY, Zhou MG, Gong XH, Wang FZ, Zheng H, Luo HM, Bi SL, Wang N, Yang WZ, Liang XF. [A sero-epidemiological study on hepatitis C in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2011 Sep;32(9):888-91. Chinese.

    PMID: 22340876BACKGROUND

  • Rao HY, Li H, Chen H, Shang J, Xie Q, Gao ZL, Li J, Sun Y, Jiang J, Wang L, Zhao L, Zhang L, Yang W, Niu J, Gong Z, Gong G, Yang R, Lee MH, Wei L. Real-world treatment patterns and clinical outcomes of HCV treatment-naive patients in China: an interim analysis from the CCgenos study. J Gastroenterol Hepatol. 2017 Jan;32(1):244-252. doi: 10.1111/jgh.13467.

    PMID: 27289083BACKGROUND

  • Lu L, Nakano T, He Y, Fu Y, Hagedorn CH, Robertson BH. Hepatitis C virus genotype distribution in China: predominance of closely related subtype 1b isolates and existence of new genotype 6 variants. J Med Virol. 2005 Apr;75(4):538-49. doi: 10.1002/jmv.20307.

    PMID: 15714489BACKGROUND

  • Chen Y, Yu C, Yin X, Guo X, Wu S, Hou J. Hepatitis C virus genotypes and subtypes circulating in Mainland China. Emerg Microbes Infect. 2017 Nov 1;6(11):e95. doi: 10.1038/emi.2017.77.

    PMID: 29089588BACKGROUND

  • Ogawa E, Furusyo N, Murata M, Hayashi T, Shimizu M, Mukae H, Toyoda K, Hotta T, Uchiumi T, Hayashi J. Impact of HCV kinetics on treatment outcome differs by the type of real-time HCV assay in NS3/4A protease inhibitor-based triple therapy. Antiviral Res. 2016 Feb;126:35-42. doi: 10.1016/j.antiviral.2015.12.001. Epub 2015 Dec 12.

    PMID: 26692214BACKGROUND

  • Matthews SJ, Lancaster JW. Telaprevir: a hepatitis C NS3/4A protease inhibitor. Clin Ther. 2012 Sep;34(9):1857-82. doi: 10.1016/j.clinthera.2012.07.011. Epub 2012 Aug 28.

    PMID: 22951253BACKGROUND

  • Heo YA, Deeks ED. Sofosbuvir/Velpatasvir/Voxilaprevir: A Review in Chronic Hepatitis C. Drugs. 2018 Apr;78(5):577-587. doi: 10.1007/s40265-018-0895-5.

    PMID: 29546556BACKGROUND

  • Feld JJ, Jacobson IM, Hezode C, Asselah T, Ruane PJ, Gruener N, Abergel A, Mangia A, Lai CL, Chan HL, Mazzotta F, Moreno C, Yoshida E, Shafran SD, Towner WJ, Tran TT, McNally J, Osinusi A, Svarovskaia E, Zhu Y, Brainard DM, McHutchison JG, Agarwal K, Zeuzem S; ASTRAL-1 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med. 2015 Dec 31;373(27):2599-607. doi: 10.1056/NEJMoa1512610. Epub 2015 Nov 16.

    PMID: 26571066BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, HCV RNA

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

daclatasvirasunaprevirombitasvirparitaprevirdasabuvirSofosbuvirvelpatasvirledipasvirelbasvirgrazoprevirdanoprevirglecaprevirpibrentasvirvoxilaprevir

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Qing Xie, MD

    Director of Department of Infectious Disease, Rui Jin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing Xie, MD

CONTACT

008613651804273xieqingrjh@163.com

Lichang Chen, MD

CONTACT

008618817555940clc@sjtu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Department of Infectious Disease, Rui Jin Hospital

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 7, 2021

Study Start

March 6, 2019

Primary Completion

July 31, 2021

Study Completion

August 31, 2021

Last Updated

July 7, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(11)