HCV InfectionNCT06952036
The Epidemic Status and Development Trend of Hepatitis C Virus Infection in Pregnant Women in Xi'an
An observational study of HCV Infection and HCV Elimination, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
The objectives of this study are to improve HCV linkage-to-care in Chinese women and provide theoretical basis for the scientific formulation of HCV prevention and control strategies for pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HCV Infection, HCV Elimination
- What is being tested?
- Standard Direct-acting antivirals (DAA) treatment procedures for patients with hepatitis C
- Type of treatment
- Surgery or procedure
- How many people
- 200,000 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women who had an antenatal visit or gave birth between 2014 and 2023.
Who may be able to join
- Pregnant women or parturient women confirmed by blood HCG test.
- Patients aged 18 years old and above.
- Patients with HCV antibody seropositive or HCV RNA positive from 2014-2023.
Who cannot join
- Patients without valid telephone numbers.
- Duplicate records: For duplicate records of the same pregnant woman, only one record should be kept.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Epidemic Status and Development Trend of Hepatitis C Virus Infection in Pregnant Women in Xi'an: A 10-Year Retrospective Study
The objectives of this study are to improve HCV linkage-to-care in Chinese women and provide theoretical basis for the scientific formulation of HCV prevention and control strategies for pregnant women.
To understand the epidemiological changes and status of hepatitis C virus (HCV) infection in pregnant women in Shaanxi province in recent 10 years, and to analyze the main influencing factors of hepatitis C infection in pregnant women.
- Conditions
- HCV Infection, HCV Elimination
- Being tested
- Standard Direct-acting antivirals (DAA) treatment procedures for patients with hepatitis C
- Keywords
- Hepatitis C, HCV elimination, Women of childbearing age
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Direct-acting antivirals (DAA) treatment procedures for patients with hepatitis CProcedure or surgery
Initiated Standard DAA treatment among HCV RNA positive patients.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women who had an antenatal visit or gave birth between 2014 and 2023. | Not described Receives: Procedure: Standard Direct-acting antivirals (DAA) treatment procedures for patients with hepatitis C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relink rate
The percentage of patients receiving DAA treatment among the diagnosed but untreated patients.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start25 Apr 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV InfectionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Yingli, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952036
- Sponsor's protocol ID
- XJTU1AF2024LSYY-413
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemic Status and Development Trend of Hepatitis C Virus Infection in Pregnant Women in Xi'an: A 10-Year Retrospective Study
- ClinicalTrials.gov ID
- NCT06952036
- Acronym / sponsor ID
- XJTU1AF2024LSYY-413
- Conditions
- HCV Infection, HCV Elimination
- Keywords
- Hepatitis C, HCV elimination, Women of childbearing age
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 25 Apr 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to improve HCV linkage-to-care in Chinese women and provide theoretical basis for the scientific formulation of HCV prevention and control strategies for pregnant women.
To understand the epidemiological changes and status of hepatitis C virus (HCV) infection in pregnant women in Shaanxi province in recent 10 years, and to analyze the main influencing factors of hepatitis C infection in pregnant women.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women who had an antenatal visit or gave birth between 2014 and 2023. | – | Procedure: Standard Direct-acting antivirals (DAA) treatment procedures for patients with hepatitis C |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women who had an antenatal visit or gave birth between 2014 and 2023.
Key inclusion criteria (3 listed)
- Pregnant women or parturient women confirmed by blood HCG test.
- Patients aged 18 years old and above.
- Patients with HCV antibody seropositive or HCV RNA positive from 2014-2023.
Key exclusion criteria (2 listed)
- Patients without valid telephone numbers.
- Duplicate records: For duplicate records of the same pregnant woman, only one record should be kept.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Direct-acting antivirals (DAA) treatment procedures for patients with hepatitis CInitiated Standard DAA treatment among HCV RNA positive patients. | Procedure or surgery | Pregnant women who had an antenatal visit or gave birth between 2014 and 2023. |
Primary outcome
Relink rate
Time frame: From enrollment to the end of treatment at 12 weeks
The percentage of patients receiving DAA treatment among the diagnosed but untreated patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of HCV Infection and HCV Elimination, run by First Affiliated Hospital Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yingli He (+86-18991232863, heyingli2000@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relink rate (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.