Optimal Time for Tenofovir Treatment of Anti-Hepatitis B Virus (HBV) During the Pregnancy

Hepatitis B, Chronic Clinical Trial

Official title:

An Open-label, Randomized, Controlled Clinical Trial to Determine the Optimal Time for Tenofovir of Anti-HBV Treatment During the Pregnancy Among Chronic HBV-infected Pregnant Women With Normal Liver Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02510963
• Other study ID #: XJTU1AHCR2014-013
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2015
• Last updated: August 9, 2016
• Start date: November 2015
• Est. completion date: August 2017

Study information

• Verified date: August 2016
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jinfeng Liu, MB
• Phone: +86-13259927840
• Email: prettycaofurong[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To determine the optimal time for the Tenofovir treatment of anti-Hepatitis B Virus (HBV) during the pregnancy among women with chronic HBV infection and high HBV DNA load. This is a randomized, open-label, three-arms, parallel-controlled clinical trial. Pregnant women with high HBV load and normal liver function will be treated with tenofovir during the middle or late stage of pregnancy, started from 24th gestational week, 28th gestational week and 32th gestational week through 1 month postpartum, respectively. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants will be compared across the three groups.

Description:

Tenofovir Disoproxil Fumarate is a American Food and Drug Administration (FDA) pregnancy class B drug. To determine the optimal time for the tenofovir treatment during the pregnancy among women with chronic HBV infection and high HBV DNA load. Pregnant women with high HBV DNA load and normal liver function at second trimester will be randomized into three treatment groups at the 20th week of gestation and treated with tenofovir from 24 weeks, 28 weeks and 32 weeks to 1 month postpartum, respectively. The blood will be drawn at 24 weeks, 28 weeks, 32 weeks, 36 weeks and the delivery, respectively and the HBV DNA load and liver functions will be tested. The status of HBV infection for infants will be observed at 1st month, 7th month and 12th month after the babies were delivered. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants and safety outcomes will be compared across the three groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women between 20 and 40 years old

• Have had HBsAg positive in serum greater than 6 months

• HBV DNA load>10**6 IU/ml

• Gestation week<24 weeks

• Normal liver function

• Able to comprehend and willing to sign the informed consent form

Exclusion Criteria:

• Combined with following infections: hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV) and human immunodeficiency virus (HIV)

• Got antiviral treatments before 24 weeks of Gestation

• Got immunosuppressor treatment and/or steroids

• Got diagnosis of cirrhosis,hepatocellular carcinoma or severe hepatitis B

• Got serious obstetric complications

• Got evidence of fetal deformity diagnosed by four-dimensional color Doppler ultrasound examination

• Biological father of infant had HBV infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Tenofovir Disoproxil Fumarate
Use Tenofovir at 24week of gestation
• Tenofovir Disoproxil Fumarate
Use Tenofovir at 28week of gestation
• Tenofovir Disoproxil Fumarate
Use Tenofovir at 32week of gestation

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV DNA load in serum	the difference in the percentage of mothers whose HBV DNA load in serum are less than 10*2 IU/ml at delivery among the groups	40 weeks, from randomization to delivery	No
Secondary	Intrauterine HBV infection rate of infants	Intrauterine HBV infection rate of infants at the 12th months after delivery	12 months, from delivery to one-year birth date	No
Secondary	Change in HBV DNA load	Total change in HBV DNA load from the start of treatment to the delivery was compared across the three groups	40 weeks, from randomization to delivery	No
Secondary	Change in hepatitis B e antigen (HBeAg) titer	Total change in HBeAg titer from the start of treatment to the delivery was compared across the three groups	40 weeks, from randomization to delivery	No