Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03695029
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 132.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Virus Infection	Drug: Tenofovir Alafenamide	Phase 4

Detailed Description

This is a multi-centered study conducted in 12-16 collaborative hospitals in Taiwan, using tenofovir as antiviral therapy to reduce mother-to-infant transmission. The study group recruited pregnant women at 2nd to 3rd trimester receive tenofovir disoproxil fumurate (TDF) 2011-2018, June, and receive tenofovir alafenamide (TAF) 2018-2021. Control group did not receive antiviral treatment. Both group receive mother and infant follow-up up to 12 months after delivery.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus
• Actual Study Start Date: Dec 29, 2010
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment group Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.	Drug: Tenofovir Alafenamide; Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.
No Intervention: control group control group receive no drug, only follow-up

Outcome Measures

Primary Outcome Measures

1. Child HBsAg 6 mo [6 months after delivery]

   Serum status of HBsAg of the infants at 6 months old

Secondary Outcome Measures

1. Child HBsAg 12 mo [12 months after delivery]

   Serum status of HBsAg of the infants at 12 months old

2. Maternal ALT elevation [6 months after delivery]

   Rate of postpartum maternal ALT elevation above 2X upper limit of normal within 6 months after delivery

3. Maternal HBeAg-seroconverion [12 months after delivery]

   HBeAg-seroconversion rate within 12 months after delivery

4. Maternal renal [6 and 12 months post delivery]

   Maternal serum creatinine (mg/dL) at 6 and 12 months post delivery

5. Materna bone marker [6 and 12 months post delivery]

   Maternal bone alkaline phosphatase (ug/L) at 6 and 12 months post delivery

6. Children's growth [6 and 12 months after birth]

   Children's growth: height (cm) in Z score at 6 and 12 months after birth

7. Children's growth [6 and 12 months after birth]

   Children's growth: weight (kg) in Z score at 6 and 12 months after birth

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Women aged 20-45 years in 28 to 32 weeks of pregnancy

• Positive HBsAg and HBeAg

• Serum viral load above 6 log10 IU/mL

Exclusion criteria:

• Major systemic disease of the mother or fetus

• Positive anti-HIV or anti-HCV

• Under treatment of antiviral therapy

• Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus

• Pregnant woman whose amniocentesis reveals any genetic abnormality

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT03695029
• Other Study ID Numbers: 201010078M
• First Posted: Oct 3, 2018
• Last Update Posted: Nov 27, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Herpesviridae Infections; Hepatitis; Tenofovir

Study Results

No Results Posted as of Nov 27, 2020