Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection

NCT04507607 | Unknown Early Phase 1

• 1 other identifier: 0237801
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The effectiveness of mother-to-child block of CHB in pregnant women in the middle and later stages of pregnancy has been recognized by the guidelines. TAF, as a newly marketed antiviral drug, has not been conclusively concluded in terms of its efficacy and postpartum safety in preventing mother-to-child transmission in pregnant women.Our purpose is to explore the TAF for CHB the curative effect of pregnant and postnatal security.

Conditions

Chronic Hepatitis B; Mother-to-child Block; Antiviral Treatment

Outcome Measures

Primary Outcomes (2)

• Liver indicators of intrapartum

  The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women at birth.

  intrapartum

• Liver indicators of postpartum

  The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women 1 month、3 month、7 month、9 month、12 month after delivery.

  12 months postpartum

Secondary Outcomes (1)

• Liver indicators of pregnancy

  24 weeks gestation until delivery

Study Arms (2)

Pregnant women with CHB

EXPERIMENTAL

Start taking TAF at 24 weeks of gestation until delivery. The liver function, viral load and antigen status were reviewed monthly and 10 ml peripheral blood was collected.

Drug: Tenofovir Alafenamide 25 MG

women with CHB

ACTIVE COMPARATOR

Nonpregnant women taking TAF for antiviral therapy were regularly rechecked for liver function, viral load, and antigens.

Drug: Tenofovir Alafenamide 25 MG

Interventions

Tenofovir Alafenamide 25 MG DRUG

TAF was administered to pregnant women with CHB during pregnancy for mother-to-child interention.Women with chronic hepatitis B who are not pregnant receive TAF for antiviral treatment.

Pregnant women with CHB; women with CHB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women with HBeAg (+), HBV DNA ≥ 2\*10\^6IU/mL who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis B were pregnant women at 24-28 weeks of pregnancy.
• non-pregnant women with HBeAg (+), HBV DNA ≥ 2\*10\^6IU/mL who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis B.
• The enrolled patients were all newly admitted patients without treatment, and if they did not meet the standard after completing the relevant examination, they would be removed.

You may not qualify if:

• Coinfection with HAV, HCV, HDV, HEV or HIV;
• A history of antiviral therapy or concurrent treatment with immunoregulatory drugs, antitumor drugs, cytotoxic drugs or immunosuppressive steroids;
• Three-dimensional ultrasonography showed fetal malformation;
• The spouse is infected with HBV;
• History of decompensated liver disease (e.g., decompensated liver disease with coagulation disorders, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites and esophageal varicose bleeding), history of liver cancer or other chronic liver disease (e.g., autoimmune hepatitis) or clinical symptoms;
• History of immune diseases;
• A history of serious cardiovascular disease;
• Other reasons the researchers considered it inappropriate to participate in the trial.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

LinChaoshuang

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

tenofovir alafenamide

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Lin

Study Record Dates

• First Submitted: July 18, 2020
• First Posted: August 11, 2020
• Study Start: August 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: June 30, 2021
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

CN (1)