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Hepatitis C Surveillance With Linkage to Care of Patients From Non-ID Departments in Jiangsu

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772002
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Chao Wu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary:

Due to the occult nature of hepatitis C virus (HCV), it is estimated that less than 5% of people with chronic hepatitis C (CHC) infection knowing their status. The major challenges are that awareness is lacking, reliable diagnostics and testing services are not sufficiently available, and laboratory capacity is weak. In the context of major tertiary hospitals, the well-functioning laboratories would ensure the high-quality HCV testing, which facilitate the identification of inpatients who are unaware of HCV infection. However, given the preliminary data, diagnostic rate of inpatients from non-infectious (non-ID) departments is disturbingly low. A recent study from a major hospital in Jilin province of China showed that 3.36% of inpatients were anti-HCV positive; however, HCV RNA confirmatory testing was not further performed in this study.

From the retrospective cohort in non-ID departments of a tertiary hospital of Jiangsu during 2016 to 2017, only 25.9% (71/273) of patients with anti-HCV antibody (Ab) further had HCV RNA confirmatory test, while 40% (29/71) were identified as CHC. The previous data indicates that insufficient anti-HCV Ab testing and insufficient follow-up of patients with positive anti-HCV Ab from non-ID departments. Indeed, compared to hospitals in Western countries, the infectious department in Chinese hospitals are relative independent from non-ID departments, meanwhile the knowledge of HCV infection is relatively lacking for non-ID physicians. Therefore, an appropriate clinical pathway for integration and linkage of non-ID department and ID departments for diagnosis and care delivery of CHC patients is urgently needed. The investigator aim to establish a feasible clinical pathway and consensus guideline to enhance HCV testing surveillance with linkage to care in non-ID departments. Moreover, the participants with anti-HCV Ab also will be enrolled in the HCV prospective cohort, in which the intervention and clinical outcome of hepatitis will be longitudinally monitored in the future study.


Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Diagnostic Test: HCV screening Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Hepatitis C Surveillance With Linkage to Care of Patients From Non-infectious Departments in Tertiary Hospitals From Jiangsu, China
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HCV screening Diagnostic Test: HCV screening
HCV antibody and HCV RNA surveillance, anti-HCV treatment assessment




Primary Outcome Measures :
  1. The percentage of patients in non-infectious departments who had positive HCV antibody testing but failed to get HCV RNA test. [ Time Frame: 1 years ]
  2. The percentage of HCV-RNA positivity among patients with the presence of anti-HCV antibody in non-infectious departments after Non-ID HCV screening. [ Time Frame: 1 years ]
  3. The percentage of HCV-RNA positivity linkage to care consensus guideline shaped. [ Time Frame: 1 years ]

Secondary Outcome Measures :
  1. The percentage of CHC patients linked to care in non-infectious departments. [ Time Frame: 1 years ]
  2. The treatment timeliness as embodied as time period from diagnosis to engagement to anti-HCV DAA treatment. [ Time Frame: 1 years ]
  3. The referral rate of identified HCV infected patients. [ Time Frame: 1 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Retrospective cohort:

  1. ≥ 18 years of age.
  2. Inpatients from non-infectious department.
  3. Documentation of laboratory test indicating positive HCV antibody.

Prospective cohort:

  1. ≥ 18 years of age.
  2. Inpatients from non-infectious departments.
  3. Patients who meet the requirement of HCV antibody screening:

    1. patients with high risk possibility of HCV infection.
    2. patients who will have special or invasive medical operation.
    3. patients with unexplained abnormal liver biochemical laboratory results.

Exclusion Criteria:

Retrospective cohort: Duplicated subjects.

Prospective cohort:Inability or unwillingness to provide informed consent or abide by the requirements of the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772002


Contacts
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Contact: Chao Wu, M.D, Ph.D. 86-25-83105890 dr.wu@nju.edu.cn
Contact: Yuxin Chen, Ph.D. 86-25-83105890 yuxin_chen2015@163.com

Locations
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China, Jiangsu
The Third Hospital of Changzhou
Changzhou, Jiangsu, China, 213001
Contact: Longgen Liu         
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Contact: Chao Wu, M.D, Ph.D    86-25-83105890    dr.wu@nju.edu.cn   
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Gilead Sciences
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Responsible Party: Chao Wu, Prof., The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT03772002    
Other Study ID Numbers: IN-CN-987-5343
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic