Current Situation of Health Care in Women With HBV or HCV Infection

ConditionsHBVHCV
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

HBV/HCV Co-infection

HIV

History of hepatic decompensation or hepatocellular carcinoma

Other carcinoma

Trial population

500 HCV Ab+ and HCV RNA + patients during 2020.7-2023.12 and 2000 HBsAg+ patients during 2016.7-2019.12

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

2,500 Participants
are grouped into 2 trial groups
Group A: HBV cohort
Group B: HCV cohort

Trial outcomes

Primary outcomes

1

Treatment Rate in male in HBV cohort

The treatment rate in male populations who meet treatment criteria recommended by China CHB guideline

Time frame
from July 2020 to December 2023
2

Treatment Rate in female in HBV cohort

The treatment rate in female populations who meet treatment criteria recommended by China CHB guideline

Time frame
from July 2020 to December 2023
3

Treatment Rate in male in HCV cohort

The treatment rate in male populations who meet treatment criteria recommended by China CHC guideline

Time frame
from July 2016 to December 2019
4

Treatment Rate in female in HCV cohort

The treatment rate in female populations who meet treatment criteria recommended by China CHC guideline

Time frame
from July 2016 to December 2019

Secondary outcomes

1

Distribution of Income levels among male in HBV cohort

categorize into 3 levels - low income (less than 50,000 CNY/year), medium income (50,000-300,000 CNY/year), high income (more than 300,000 CNY/year), in male populations infected with HBV

Time frame
from July 2020 to December 2023
2

Distribution of Income levels among female in HBV cohort

categorize into 3 levels - low income (less than 50,000 CNY/year), medium income (50,000-300,000 CNY/year), high income (more than 300,000 CNY/year), in female populations infected with HBV

Time frame
from July 2020 to December 2023
3

Distribution of medical insurance type in male in HCV cohort

categorize into 4 types - employee medical insurance, resident medical insurance, new rural cooperative medical scheme, self-pay, in male populations infected with HCV

Time frame
from July 2016 to December 2019
4

Distribution of medical insurance type in female in HCV cohort

categorize into 4 types - employee medical insurance, resident medical insurance, new rural cooperative medical scheme, self-pay, in male populations infected with HCV

Time frame
from July 2016 to December 2019

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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