Hepatitis B Trial, Recruiting NCT06947356 Sponsor: Guangzhou 8th People's Hospital Condition: Hepatitis B
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Hepatitis B Trial, Recruiting

NCT06947356
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a pregnant woman between 20 and 40 years old
  • Your pregnancy is between 20 and 28 weeks along
  • You have been diagnosed with chronic hepatitis B that is considered "compensated" (meaning your liver is still functioning), and you have tested positive for the hepatitis B surface antigen (HBsAg) for more than 6 months
  • Your blood tests during screening show positive results for both HBsAg and HBeAg (specific hepatitis B markers)
  • A blood test shows that the hepatitis B virus level in your blood is higher than 200,000 IU/mL
  • You are willing to follow the study's treatment plan and all other study requirements, including avoiding pregnancy for 28 weeks after giving birth
  • Both you and your baby's biological father understand the risks involved, you are joining voluntarily, and you are willing to sign a written consent form before the study begins

Who may not be able to join:

  • Your kidneys are not filtering blood well enough (below a certain level calculated by a specific method), or your blood phosphate levels are too low
  • You have had bad kidney side effects from a drug called Adefovir in the past, or the hepatitis B virus in your body has become resistant to Adefovir
  • Your blood test results show any of the following: very low red blood cells, very low white blood cells, liver enzyme (ALT) levels more than 5 times the normal limit, high bilirubin, low albumin, or abnormal kidney markers (confirm with trial site)
  • You have a history of miscarriage, have previously given birth to a baby with birth defects, or have had a baby previously infected with hepatitis B
  • The biological father of your current pregnancy has chronic hepatitis B
  • The trial doctors believe you have a significant kidney, heart, lung, or neurological (nervous system) condition that could affect your ability to safely take part in the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +86 13632293277

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Guangzhou 8th People's Hospital
Registry
ClinicalTrials.gov
Start date
3 May 2025
Est. completion
1 May 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The mother-to-child transmission rate of HBV

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov