Current Situation of Health Care in Women With HBV or HCV Infection
1 other identifier
observational
2,500
0 countries
N/A
Brief Summary
A multicenter, retrospective study conducted in male and female population infected with HBV or HCV in east China. HCV part, study will enroll 500 HCV antibody positive and HCV RNA positive patients during 2020.7-2023.12 and then observe the characteristics, duration from diagnosis to treatment, treatment rate and sustained virologic response (SVR12) among eligible female and male patients. HBV part, study will enroll 2000 HBsAg positive patients during 2016.7-2019.12 and then observe the clinical characteristics, natural history, duration from diagnosis to treatment, treatment rate and adherence among eligible female and male patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2024
CompletedFirst Posted
Study publicly available on registry
August 30, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedAugust 30, 2024
August 1, 2024
8 months
August 22, 2024
August 29, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Treatment Rate in male in HBV cohort
The treatment rate in male populations who meet treatment criteria recommended by China CHB guideline
from July 2020 to December 2023
Treatment Rate in female in HBV cohort
The treatment rate in female populations who meet treatment criteria recommended by China CHB guideline
from July 2020 to December 2023
Treatment Rate in male in HCV cohort
The treatment rate in male populations who meet treatment criteria recommended by China CHC guideline
from July 2016 to December 2019
Treatment Rate in female in HCV cohort
The treatment rate in female populations who meet treatment criteria recommended by China CHC guideline
from July 2016 to December 2019
Secondary Outcomes (4)
Distribution of Income levels among male in HBV cohort
from July 2020 to December 2023
Distribution of Income levels among female in HBV cohort
from July 2020 to December 2023
Distribution of medical insurance type in male in HCV cohort
from July 2016 to December 2019
Distribution of medical insurance type in female in HCV cohort
from July 2016 to December 2019
Study Arms (2)
HBV cohort
2000 HBsAg positive patients during 2016.7-2019.12
HCV cohort
500 HCV Ab positive and HCV RNA positive patients during 2020.7-2023.12
Eligibility Criteria
500 HCV Ab+ and HCV RNA + patients during 2020.7-2023.12 and 2000 HBsAg+ patients during 2016.7-2019.12
You may qualify if:
- HBV Cohort -
- ≥18 years old
- serum HBsAg positive for \>6 months
- Treatment naïve or,
- Patients who had been previously treated for HBV but discontinued for at least 1 year before enrollment
- HCV Cohort -
- ≥18 years old
- HCV-Ab positive
- HCV RNA positive
- Treatment naïve or,
- Patients who had been previously treated for HCV with a regimen containing interferon and not had a sustained virologic response.
You may not qualify if:
- HBV/HCV Co-infection
- HIV
- History of hepatic decompensation or hepatocellular carcinoma
- Other carcinoma
- Other severe liver disease
- Severe Comorbidity like cardiovascular disease, diabetes etc.
- Patients who had discontinued previous HCV treatment because of an adverse event.
- Patients who had previously received any nucleotide analogue HCV NS5B inhibitor or any NS5A inhibitor
- Patients who had discontinued previous HBV treatment because of an adverse event.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Officials
- PRINCIPAL INVESTIGATOR
Qing Xie
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2024
First Posted
August 30, 2024
Study Start
September 1, 2024
Primary Completion
April 30, 2025
Study Completion
July 31, 2025
Last Updated
August 30, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share