|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
13 February 2023 |
|
Main ID: |
NCT02995005 |
|
Date of registration:
|
08/12/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Tenofovir in Early Pregnancy to Prevent Mother-to-child Transmission of Hepatitis B Virus
|
|
Scientific title:
|
Prevention of Mother-to-child Transmission of Hepatitis B Virus: a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy |
|
Date of first enrolment:
|
May 24, 2018 |
|
Target sample size:
|
98 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02995005 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
Thailand
| | | | | | | |
|
Contacts
|
|
Name:
|
Stephan Ehrhardt, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Johns Hopkins Bloomberg School of Public Health |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Pregnant women aged 18 and over
- HBsAg positive
- In the 12th-20th week of pregnancy
- Willing to take TDF daily during pregnancy
- Providing written informed consent
- Plans to deliver at Shoklo Malaria Research Unit (SMRU)
- Able and willing to comply with study requirements
Exclusion Criteria:
- Anti-HIV positive
- Negative qualitative HBV DNA if HBeAg negative
- On immunosuppressive therapy
- Elevated creatinine
- History of kidney disease
- Short cervix
- History of pregnancy complications or prior pre-term labor
Age minimum:
16 Years
Age maximum:
49 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Hepatitis B
|
|
Intervention(s)
|
|
Drug: Tenofovir Disoproxil Fumarate
|
|
Primary Outcome(s)
|
|
The time (from inclusion through delivery; up to 6 months) to HBV DNA suppression (<100 IU/ml)
[Time Frame: Up to 9 months]
|
|
The proportion of women with undetectable HBV DNA at delivery
[Time Frame: At delivery]
|
|
Secondary Outcome(s)
|
|
The proportion of women who adhered to TDF treatment during the course of the study (from inclusion through 1 month after delivery; up to 7 months; drug accountability)
[Time Frame: Up to 9 months]
|
|
Proportion of hepatitis B flares in mothers postpartum
[Time Frame: Monthly measured for 3 months after stopping TDF.]
|
|
The proportion of women who adhered to TDF treatment during the course of the study (from inclusion through 1 month after delivery; up to 7 months; drug levels)
[Time Frame: Up to 9 months]
|
|
The proportion of hepatitis B infections in the offspring at 1 year of age
[Time Frame: Between month 2 and 12 month]
|
|
The proportion of women who adhered to TDF treatment during the course of the study (from inclusion through 1 month after delivery; up to 7 months; questionnaire)
[Time Frame: Up to 9 months]
|
|
Secondary ID(s)
|
|
JHSPH-TDF
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|