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 : January 18, 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|
|Anticipated Study Start Date :||February 28, 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|