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Trial record 57 of 362 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

TDF Medicine to Prevent Mother to Child Transmission of Hepatitis B (TDF)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified May 2017 by University of Oxford
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT03167229
First received: April 24, 2017
Last updated: May 23, 2017
Last verified: May 2017
  Purpose

Our goal is to determine the viral kinetics of HBV DNA reduction in 170 non-Thai pregnant women receiving Tenofovir disoproxil fumarate (TDF) to inform a subsequent RCT. The investigators also aim to determine adherence to daily TDF in pregnancy as new interventions must not only be effective but also safe, feasible and acceptable in the local, and ideally global, context.

Study Design: One arm, open label, Tenofovir treatment intervention study

Study Participants: Non-Thai pregnant women estimated gestation 12-20 weeks and their offspring

Planned Sample Size: 170

Primary Objective To estimate the time to HBV DNA suppression (<100 IU/ml) in 170 HBV DNA positive women who start TDF late in the first or early in the second trimester.

Outcome Measures Time in months to HBV DNA < 100 IU/ml

Secondary Objectives

  1. To estimate the proportion of women with HBV DNA <100 IU/ml at delivery.
  2. To estimate the TDF levels at delivery in women who are HBV DNA detectable and undetectable.
  3. To monitor safety of TDF in the Thailand-Myanmar border women
  4. To address potential barriers to implementing TDF in early pregnancy to PMTCT-HBV.
  5. To determine the rate of hepatic flares post-partum.
  6. To estimate the proportion of cases of vertical transmission at 2 months of age.
  7. Fetal growth monthly ultrasound, infant growth at 1,2,3,6,12 and neurodevelopment at 6 and 12 months

Condition Intervention Phase
Hepatitis B Drug: Tenofovir Disoproxil Fumarate Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Prevention of Mother-to-child Transmission of Hepatitis B Virus (PMTCT-HBV): a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Time in months to HBV DNA < 100 IU/ml [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Proportion of women with HBV DNA < 100 IU/ml at delivery [ Time Frame: 3 years ]
  • Mean TDF level at delivery in selected cases: 10-15 women who are HBV DNA detectable and a matched 20-30 women who are undetectable. [ Time Frame: 3 years ]
  • Adverse events specified clinically (headache, nausea, vomiting) [ Time Frame: 3 years ]
    To monitor safety of TDF

  • Laboratory testing (HBV DNA levels, ALT, AST, Cr) and serum phosphate [ Time Frame: 3 years ]
    To monitor safety of TDF

  • Questionnaires [ Time Frame: 3 years ]
    Adherence by pill counts.

  • The proportion of women with elevated AST/ALT (defined as >5x baseline or >10x the upper limit of normal) [ Time Frame: 1 years ]
    AST/ALT baseline monthly, delivery and post-partum for 3 months after stopping TDF.

  • Proportion of infants that are positive for HBsAg and HBV DNA at birth (cord blood) and 2 months of age. [ Time Frame: 1 years ]
    Infant HBsAg and HBeAg in cord blood and HBV DNA from cord blood and HBsAg at 2 months of age

  • Fetal and infant anthropometry and infant neurodevelopment will be compared to normative data from this population. [ Time Frame: 1 years ]
    Fetal (HC, AC, FL EFW monthly in-utero) and infant anthropometry (body weight, HC, AC at 1,2,3,6,9,12 months), Shoklo Developmental Test at 6, 12 months.


Estimated Enrollment: 170
Anticipated Study Start Date: June 1, 2017
Estimated Study Completion Date: June 1, 2020
Estimated Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tenofovir Drug: Tenofovir Disoproxil Fumarate
Daily tenofovir 300 mg will be self-administered by the woman and continued until one month post-partum. Discussions about the study drug are ongoing and the investigators aim to have Gilead, the manufacturer of Tenofovir (VireadTM) provides the drug free of charge, however in the event that this is not possible the investigators will then purchase generic TDF. The drug will be delivered directly to the study site at Mae Sot.

  Eligibility

Ages Eligible for Study:   16 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The woman is willing and able to give informed consent for participation in the study.
  • Hepatitis B infected (HBsAg confirmed positive)
  • Female, 16-49 years (inclusive).
  • Estimated gestational age of 12-20 weeks at time TDF is started.
  • Willing to take TDF daily during pregnancy.
  • Plans to deliver at SMRU (Maw KerThai and Wang Pha SMRU ANC).
  • Able (in the Investigators opinion) and willing to comply with all study requirements

Exclusion Criteria:

  • HIV positive or on immunosuppressive therapy for other illnesses
  • elevated creatinine (>1.0 mg/dL)
  • abnormal serum phosphate (<2.4 and >4.5 mg/dL)
  • history of kidney disease
  • History of pregnancy complications, short cervix
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03167229

Contacts
Contact: Rose McGready, MD 0817853585 rose@shoklo-unit.com

Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Rose McGready, MD University of Oxford
  More Information

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03167229     History of Changes
Other Study ID Numbers: SMRU1702
Study First Received: April 24, 2017
Last Updated: May 23, 2017
Individual Participant Data  
Plan to Share IPD: Yes

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 University of Oxford:
Tenofovir
Hepatitis B

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

ClinicalTrials.gov processed this record on June 27, 2017