NCT05853718 Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women
| NCT ID | NCT05853718 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | First People's Hospital of Hangzhou |
| Condition | Chronic Hepatitis b |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-05-06 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2021-05-06 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics, efficacy and safety of TAF in HBV-infected pregnant women.
Eligibility Criteria
Inclusion Criteria: * Age of 20-40 years; Positive for hepatitis B surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg); HBV DNA level \>200 000 IU/mL during the 24th-32nd week of pregnancy; Willing to take TAF for mother-to-child blockade; Both husband and wife are willingly sign an informed consent. Exclusion Criteria: * Co-infected with hepatitis C or HIV, or other chronic diseases; History of spontaneous abortion or congenital malformation; Decompensated cirrhosis and liver cancer; History of kidney injury, CCr \<50ml/min and urine protein test positive (\>300mg/L); Fetal malformations detected by B-ultrasound during pregnancy; ALT \> 2×upper limit of normal (ULN); TBIL ≥ 1×ULN; Albumin (ALB) \< 25 g/L.
Contact & Investigator
Zhiyuan Ma, PhD
PRINCIPAL INVESTIGATOR
First People's Hospital of Hangzhou
Frequently Asked Questions
Who can join the NCT05853718 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 40 Years, studying Chronic Hepatitis b. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05853718 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05853718 currently recruiting?
Yes, NCT05853718 is actively recruiting participants. Contact the research team at jinjie0429@163.com for enrollment information.
Where is the NCT05853718 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05853718 clinical trial?
NCT05853718 is sponsored by First People's Hospital of Hangzhou. The principal investigator is Zhiyuan Ma, PhD at First People's Hospital of Hangzhou. The trial plans to enroll 50 participants.