Tenofovir in Early Pregnancy to Prevent Mother-to-child Transmission of Hepatitis B Virus
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|ClinicalTrials.gov Identifier: NCT02995005|
Recruitment Status : Not yet recruiting
First Posted : December 16, 2016
Last Update Posted : April 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B||Drug: Tenofovir Disoproxil Fumarate||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single group study.|
|Masking:||None (Open Label)|
|Masking Description:||No maksing, just one interventional group.|
|Official 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|
|Estimated Study Start Date :||May 31, 2018|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Tenofovir Disoproxil Fumarate
Women early in pregnancy (end of first or beginning second trimester) will be treated with TDF to determine the efficacy of this strategy to bring >=95% of women to undetectable HBV DNA levels at delivery.
Drug: Tenofovir Disoproxil Fumarate
300 mg daily
Other Name: Viread
- The time (from inclusion through delivery; up to 6 months) to HBV DNA suppression (<100 IU/ml) [ Time Frame: Every month ]HBV DNA will be monitored every month
- The proportion of women with undetectable HBV DNA at delivery [ Time Frame: At delivery ]HBV DNA will be monitored at delivery.
- Proportion of hepatitis B flares in mothers postpartum [ Time Frame: Monthly measured for 3 months after stopping TDF. ]All women will continue on study for 3 months after stopping TDF to measure their alanine aminotransferase (ALT) and aspartate aminotransferase (AST) monthly to detect a flare, which will be defined as >5x baseline or >10x the upper limit of normal. If at the end of the 3 months, there has been no change in ALT and AST, then the mothers will be discharged from the study. If there is an increase in liver enzymes but not a true flare, they will be followed for an additional 3 months with monthly ALT testing.
- 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) [ Time Frame: Every month ]All women will be surveyed at monthly visits and at birth to measure adherence including actionable barriers.
- 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) [ Time Frame: Every month ]Drug accountability using standard methods (subtracting the number of tablets left from the number of tablets distributed).
- 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) [ Time Frame: Every month ]Measurement of tenofovir drug levels
- The proportion of hepatitis B infections in the offspring at 1 year of age [ Time Frame: Between month 2 and 12 month ]Testing for HBsAg in children between 2 and 12 months of age.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995005
|Contact: Stephan Ehrhardt, MDfirstname.lastname@example.org|
|Shoklo Malaria Research Unit||Not yet recruiting|
|Mae Sot, Thailand|
|Contact: Rose McGready +66 5554 5021 SMRU@tropmedres.ac|
|Principal Investigator:||Stephan Ehrhardt, MD||Johns Hopkins Bloomberg School of Public Health|