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Trial record 28 of 309 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Tenofovir in Early Pregnancy to Prevent Mother-to-child Transmission of Hepatitis B Virus

This study is not yet open for participant recruitment.
Verified August 2017 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT02995005
First Posted: December 16, 2016
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Thrasher Research Fund
Shoklo Malaria Research Unit
Chiang Mai University
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
  Purpose
Mother-to-child transmission (MTCT) of hepatitis B virus (HBV) remains the major mode of transmission in most high and intermediate HBV endemic areas, despite existing WHO immunoprophylaxis recommendations. This immunoprophylaxis regimen, if given optimally, can prevent 75-80% of HBV MTCT, but optimal implementation is difficult because it requires administering monovalent HBV vaccine and hepatitis B immunoglobulin (HBIg) within 24 hours of birth. Due to the barriers of giving HBIg, the World Health Organization (WHO) states, "…owing to concerns related to supply, safety and cost, the use of HBIg is not feasible in most settings." Clearly, global control of HBV transmission will require improved MTCT prevention. Therefore, the investigators hypothesize that treating HBV early in pregnancy will lead to undetectable HBV DNA levels at delivery and prevention of MTCT of HBV without HBIg; a concept that has already been proven with HIV. Tenofovir disoproxil fumarate (TDF), an approved anti-HBV drug, is promising to prevent MTCT of HBV due to its high potency against hepatitis B and its safety record in pregnant women. A randomized, controlled clinical trial (RCT) will be necessary to determine if TDF given to HBV-infected pregnant women early in pregnancy plus vaccine to the newborn can decrease MTCT of HBV without HBIg. However, before embarking on a RCT, several critical knowledge gaps need to be addressed including the ideal timing for TDF initiation. The purpose of this proposal is to address these knowledge gaps.

Condition Intervention Phase
Hepatitis B Drug: Tenofovir Disoproxil Fumarate Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Single group study.
Masking: None (Open Label)
Masking Description:
No maksing, just one interventional group.
Primary Purpose: Prevention
Official Title: Tenofovir in Early Pregnancy to Prevent Mother-to-child Transmission of Hepatitis B Virus

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 170
Anticipated Study Start Date: October 1, 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
The investigators hypothesize that anti-HBV therapy given in the late first or early second trimester achieves undetectable HBV DNA at delivery in >=95% of pregnant women with chronic hepatitis B. The one-arm, open-label, interventional study aims: 1, To estimate the time to complete HBV DNA suppression (<100 IU/ml) in 170 HBV DNA positive women who start TDF in the late first or early second trimester; and to estimate the proportion of women with HBV DNA <100 IU/ml at delivery. 2, To address potential barriers to and the efficacy of implementing TDF in early pregnancy to prevent mother-to-child transmission of hepatitis B. The investigators will measure potential barriers to acceptability and effectiveness of this intervention: adherence, potential hepatitis B flares in mothers (safety), and the proportion of hepatitis B infections in the offspring at 1 year of age (efficacy).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

  • Anti-HIV positive
  • On immunosuppressive therapy
  • Elevated creatinine
  • History of kidney disease
  • Short cervix
  • History of pregnancy complications or prior pre-term labor
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Stephan Ehrhardt, MD 410-502-3872 sehrhard@jhsph.edu

Locations
Thailand
Shoklo Malaria Research Unit Not yet recruiting
Mae Sot, Thailand
Contact: Rose McGready    +66 5554 5021    SMRU@tropmedres.ac   
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Thrasher Research Fund
Shoklo Malaria Research Unit
Chiang Mai University
Investigators
Principal Investigator: Stephan Ehrhardt, MD Johns Hopkins Bloomberg School of Public Health
  More Information

Publications:

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02995005     History of Changes
Other Study ID Numbers: JHSPH-TDF
First Submitted: December 8, 2016
First Posted: December 16, 2016
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators are currently developing an individual participant data (IPD) sharing plan.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
mother to child transmission
hepatitis B
tenofovir

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents