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Trial record 17 of 312 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection

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.
ClinicalTrials.gov Identifier: NCT03343431
Recruitment Status : Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
Most new hepatitis B virus (HBV) infections are acquired perinatally. In this study, pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate during the last trimester of pregnancy and for two months following delivery. Their infants will receive hepatitis B (HB) immunization, starting with a first dose soon after birth. We hypothesize that the risk of mother-to-child transmission of HBV will be lower than 2%. The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.

Condition or disease Intervention/treatment Phase
Hepatitis B Pregnancy Drug: Tenofovir disoproxil fumarate Phase 3

Detailed Description:

This is a prospective multi-center, multi-country (Thailand and Lao PDR), open-label, single arm clinical trial in HBsAg and HBeAg positive pregnant women (from 28 weeks until one year postpartum) and their infants (until 18 months of age). Pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate 300 mg once daily from 28 weeks of pregnancy until two months postpartum. Their infants will receive hepatitis B (HB) immunization, starting with the first dose soon after birth.

The study aims to show that substituting maternal antiviral treatment for infant HBIg can be favorably considered in settings where HBIg plus vaccine has been used as well as in settings where only vaccine is used. A significant improvement over the standard HBIg + vaccine strategy would be that adding an antiviral strategy results in less than 2% transmission. A total of 499 women and their infants will be enrolled in public hospitals in Thailand and Lao PDR.

The study will be monitored by a Data and Safety Monitoring Board (DSMB) at least annually.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 499 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Maternal Short Course of Tenofovir Disoproxil Fumarate and Infant Vaccine to Prevent Mother-to-child Transmission of Hepatitis B Virus
Anticipated Study Start Date : December 1, 2017
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Tenofovir disoproxil fumarate
Intervention: administration of tenofovir disoproxil fumarate Form: 300 mg tablets Dosage: 1 tablet once a day Duration: 5 months
Drug: Tenofovir disoproxil fumarate
Tenofovir disoproxil fumarate (TDF), one 300 mg tablet once a day from 28 weeks' gestation through two months postpartum.

Outcome Measures

Primary Outcome Measures :
  1. Infant hepatitis B infection status [ Time Frame: Six months of age ]
    HBsAg positive confirmed by PCR detection of HBV DNA.

Secondary Outcome Measures :
  1. Maternal HBV DNA changes [ Time Frame: From enrollment until end of study treatment scheduled 2 months after delivery ]
    Description of the effect of tenofovir disoproxil fumarate on maternal HBV DNA levels

  2. Infant levels of anti-HBs antibodies [ Time Frame: At 1, 2, 4, 6, and 12 months of age ]
    Levels of anti-HBs antibodies in infants in the absence of HBIg administration at birth

  3. HBV infection status in all infants regardless of maternal response to study treatment [ Time Frame: At 6 months of age ]
    HBsAg positive confirmed by PCR detection of HBV DNA in all infants, i.e. including those born to women with unsatisfactory virological response to study treatment

  4. Serious adverse events [ Time Frame: From enrollment until 12 months postpartum ]
    Occurrence of maternal serious adverse events (ICH SAEs) including DAIDS grade 4 signs and symptoms regardless of their relatedness to the study treatment

  5. Serious adverse events [ Time Frame: From birth until 12 months of age ]
    Occurrence of infant serious adverse events (ICH SAEs) including DAIDS grade 4 signs and symptoms regardless of their relatedness to the study treatment

  6. Preterm live births [ Time Frame: Delivery ]
    Proportion of neonates born alive before 37 weeks of pregnancy

  7. Low birth weight [ Time Frame: Delivery ]
    Proportion of neonates born alive with birth weight of 2,499 g or less, regardless of gestational age

  8. Active or previous transient infection in children [ Time Frame: At 18 months of age ]
    Detection of anti-HBc antibodies among all infants

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pregnancy
  • Age ≥18 years
  • Negative HIV antibody test during current pregnancy
  • Positive HBsAg and HBeAg tests during current pregnancy
  • Absence of clinical symptoms of liver disease
  • Gestational age of 28 weeks (+/- 7 days) based on the obstetrician judgment guided by the review of the date of last menstruation period.
  • Willing and able to provide written informed consent
  • Agreeing to bring her infants(s) at the planned study visits at one of the study site until the last visit (18 months after birth) and to inform the site investigators if plans to move to another place and not be able to return to the clinic
  • Understand the need for adequate infant immunization for her infant(s) and accept that blood draws will be performed to determine the infant HBV infection status

Exclusion Criteria:

  • Receipt of anti-HBV antivirals at any time during the last 9 months
  • Known liver cirrhosis or evidence of hepatocellular carcinoma
  • Creatinine clearance <50 ml/min, calculated using the Cockcroft-Gault formula
  • Confirmed dipstick proteinuria >1+ (>30 mg/dL) or normoglycemic glycosuria
  • Evidence of pre-existing fetal anomalies incompatible with life
  • Any concomitant condition or treatment that, in the view of the clinical site investigator, would contraindicate participation or compromise adherence to treatment and satisfactory follow up in the study.
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): NCT03343431

Contact: Gonzague Jourdain, MD, PhD +66818830065 Gonzague.Jourdain@ird.fr
Contact: Nicole Ngo-Giang-Huong, PharmD, PhD +66898511178 Nicole.Ngo-Giang-Huong@phpt.org

Lao People's Democratic Republic
Mahosot Hospital Not yet recruiting
Vientiane, Lao People's Democratic Republic
Contact: Anan Sackpraseuth, MD       anansps@yahoo.com   
Principal Investigator: Anan Sackpraseuth, MD         
Mother and Child Health (MCH) Hospital Not yet recruiting
Vientiane, Lao People's Democratic Republic
Contact: Touy Chanthalansy, MD       patouy.c@gmail.com   
Contact: Ouiphone Viyarath, MD         
Principal Investigator: Touy Chanthalansy, MD         
Principal Investigator: Ouiphone Viyarath, MD         
Setthathirath Hospital Not yet recruiting
Vientiane, Lao People's Democratic Republic
Contact: Khamla Choumlivong, MD       khamla_choumlivong@yahoo.com   
Contact: Vatsana Phonsena, MD       Vatsana-phonsena@hotmail.com   
Principal Investigator: Khamla Choumlivong, MD         
Principal Investigator: Vatsana Phonsena, MD         
Mae Sai Hospital Not yet recruiting
Mae Sai, Chiang Rai, Thailand, 57130
Contact: Jariyarat Nitipipatkosol, MD    +66 53731 301    cookie.aom@hotmail.com   
Principal Investigator: Jariyarat Nitipipatkosol, MD         
Mae Chan Hospital Not yet recruiting
Mae Chan, Chiangrai, Thailand, 57110
Contact: Iyara Wongpia, MD    +6653771056    dr_iyara@hotmail.com   
Principal Investigator: Iyara Wongpia, MD         
Mahasarakam Hospital Not yet recruiting
Maha Sarakham, Mahasarakham, Thailand, 44000
Contact: Wakul Lanjakornsiripan, MD    +66 4374 0993    manju.sung@gmail.com   
Contact: Sathaporn Na-Rajsima, MD    +66 4374 0993    sathapongpong@yahoo.com   
Principal Investigator: Wakul Lanjakornsiripan, MD         
Principal Investigator: Sathaporn Na-Rajsima, MD         
Chiang Kham Hospital Not yet recruiting
Chiang Kham, Phayao, Thailand, 56110
Contact: Chaiwat Putiyanun, MD    +6654451300-1    putiyanun@hotmail.com   
Principal Investigator: Chaiwat Putiyanun, MD         
Hat Yai Hospital Not yet recruiting
Hat Yai, Songkla, Thailand, 90110
Contact: Kosit Tantinam, MD    +66 7423 0800    kosittantinam@hotmail.com   
Contact: Rachanee Saksawad, MD    +66 7423 0800    toncherry2710@gmail.com   
Principal Investigator: Kosit Tantinam, MD         
Principal Investigator: Rachanee Saksawad, MD         
Bhumibol Adulyadej Hospital Not yet recruiting
Bangkok, Thailand, 10220
Contact: Sinart Prommas, MD    +6625347317    nprommas@gmail.com   
Contact: Jutarat Mekmullica, MD    +6625347306    jmekmullica@yahoo.com   
Principal Investigator: Sinart Prommas, MD         
Principal Investigator: Jutarat Mekmullica, MD         
Nopparat Rajathanee Hospital Not yet recruiting
Bangkok, Thailand, 10230
Contact: Orada Patamasingh Na Ayudhaya, MD    +6625174270-9    oradaaom@hotmail.com   
Contact: Anita Luvira, MD    +6625174270-9    aluvira@yahoo.com   
Principal Investigator: Orada Patamasingh Na Ayudhaya, MD         
Principal Investigator: Anita Luvira, MD         
Bhuddasothorn Hospital Not yet recruiting
Chachoengsao, Thailand, 24000
Contact: Pravit Intrarasukum, MD    +66 3881 4375    bumnoi@hotmail.com   
Contact: Ratchanee Kwanchaipanich, MD    +66 3881 4375    rutchaneekwan@yahoo.co.th   
Principal Investigator: Pravit Intrarasukum, MD         
Principal Investigator: Ratchanee Kwanchaipanich, MD         
Prapokklao Hospital Not yet recruiting
Chanthaburi, Thailand, 22000
Contact: Sirida Kositchaiwat, MD    +6639324975 ext 5253    Barbieaee@hotmail.com   
Contact: Kanokkorn Swasdichai, MD    +6639324975 ext 5253      
Principal Investigator: Sirida Kositchaiwat, MD         
Principal Investigator: Kanokkorn Swasdichai, MD         
Health Promotion Center Region 1 Not yet recruiting
Chiang Mai, Thailand, 50100
Contact: Suraphan Sangsawang, MD    +6653272740    suraphan3107@hotmail.com   
Contact: Chotiros Phanpong, MD    +6653272740    choti001@hotmail.com   
Principal Investigator: Suraphan Sangsawang, MD         
Principal Investigator: Chotiros Phanpong, MD         
Sanpatong Hospital Not yet recruiting
Chiang Mai, Thailand, 50120
Contact: Prayoon Khamja, MD    +66 5331 1404    prayoon123@yahoo.com   
Contact: Noppadon Akarathum, MD    +66 5331 1404    nakaratham@gmail.com   
Principal Investigator: Prayoon Khamja, MD         
Principal Investigator: Noppadon Akarathum, MD         
Nakornping Hospital Not yet recruiting
Chiang Mai, Thailand, 50180
Contact: Aram Limtrakul, MD    +6653999200    aramlim@hotmail.com   
Contact: Arunrat Suwannarat, MD    +6653999200    arunrat11@yahoo.com   
Principal Investigator: Aram Limtrakul, MD         
Principal Investigator: Arunrat Suwannarat, MD         
Chiangrai Prachanukroh Hospital Not yet recruiting
Chiang Rai, Thailand, 57000
Contact: Jullapong Achalapong, MD    +6653711300 ext 1217    jullapongachalapong@gmail.com   
Contact: Chulapong Chanta, MD    +6653711300 ext 1274    Chul_chan@yahoo.com   
Principal Investigator: Jullapong Achalapong, MD         
Principal Investigator: Chulapong Chanta, MD         
Chonburi Hospital Not yet recruiting
Chon Buri, Thailand, 20000
Contact: Nantasak Chotivanich, MD    +6638931000    nantasak.cho@gmail.com   
Contact: Ketesiree Kornsitthikul, MD    +663827400-7    tarenaruk@hotmail.com   
Principal Investigator: Nantasak Chotivanich, MD         
Principal Investigator: Ketesiree Kornsitthikul, MD         
Banglamung Hospital Not yet recruiting
Chon Buri, Thailand, 20150
Contact: Prateep Kanjanavikai, MD    +6638411551-2    prateep48@hotmail.com   
Contact: Siriluk Phanomcheong, MD    +6638411551-2    siriluk_lukk@yahoo.com   
Principal Investigator: Prateep Kanjanavikai, MD         
Principal Investigator: Siriluk Phanomcheong, MD         
Kalasin Hospital Not yet recruiting
Kalasin, Thailand, 46000
Contact: Phaiboon Wanasiri, MD    +66 4381 1020    piboon_wan@hotmail.com   
Contact: Sakulrat Srirojana, MD    +66 4381 1020    sakulrats@yahoo.com   
Principal Investigator: Phaiboon Wanasiri, MD         
Principal Investigator: Sakulrat Srirojana, MD         
Phaholpolpayuhasena Hospital Not yet recruiting
Kanchanaburi, Thailand, 71000
Contact: Yupa Srivarasat, MD    +66 3462 2999    yupa2503@hotmail.com   
Contact: Pornsawan Attavinijtrakarn, MD    +66 3462 2999    Pahol_psawan@hotmail.com   
Principal Investigator: Yupa Srivarasat, MD         
Principal Investigator: Pornsawan Attavinijtrakarn, MD         
Khon Kaen Regional Hospital Not yet recruiting
Khon Kaen, Thailand, 40000
Contact: Thitiporn Siriwachirachai, MD    +6643336789    dthitiporn@gmail.com   
Contact: Ussanee Srirompotong, MD    +6643336789    u.srirompotong@gmail.com   
Principal Investigator: Thitiporn Siriwachirachai, MD         
Principal Investigator: Ussanee Srirompotong, MD         
Lampang Hospital Not yet recruiting
Lampang, Thailand, 52000
Contact: Prateung Liampongsabuddhi, MD    +6654223623-7    prateung@yahoo.com   
Contact: Kultida Pongdetudom, MD    +6654223623-7    pongdetudom@yahoo.com   
Principal Investigator: Prateung Liampongsabuddhi, MD         
Principal Investigator: Kultida Pongdetudom, MD         
Lamphun Hospital Not yet recruiting
Lamphun, Thailand, 51000
Contact: Wanmanee Matanasarawut, MD    +6653569100 ext 2150    obgyn.lph@gmail.com   
Contact: Rosalin Somsamai, MD    +6653569100    Ross_noi@hotmail.com   
Principal Investigator: Wanmanee Matanasarawut, MD         
Principal Investigator: Rosalin Somsamai, MD         
Maharat Nakhon Ratchasima Hospital Not yet recruiting
Nakhon Ratchasima, Thailand, 30000
Contact: Pichit Puernngoluerm, MD    +6644235000    bank_pichit@yahoo.com   
Contact: Anucha Saereejittima, MD    +6644235000    anuchasae@gmail.com   
Principal Investigator: Pichit Puernngoluerm, MD         
Principal Investigator: Anucha Saereejittima, MD         
Maharaj Nakhon Si Thammarat Hospital Not yet recruiting
Nakhon Si Thammarat, Thailand, 80000
Contact: Rujira Panpob, MD    +66 7534 0250    ruparapob@gmail.com   
Contact: Somsri Kotchawet, MD    +66 7534 0250    somsrikot@yahoo.com   
Principal Investigator: Rujira Panpob, MD         
Principal Investigator: Somsri Kotchawet, MD         
Nong Khai Hospital Not yet recruiting
Nong Khai, Thailand, 43000
Contact: Sunida Panna, MD    +66 4246 1088    kungkliag@yahoo.com   
Contact: Surapon Eartrakulpaiboon, MD    +66 4246 1088    dr.surapon@hotmail.com   
Principal Investigator: Sunida Panna, MD         
Principal Investigator: Surapon Eartrakulpaiboon, MD         
Phayao Provincial Hospital Not yet recruiting
Phayao, Thailand, 56000
Contact: Pornnapa Suriyachai, MD    +6654431209    whan76_1@hotmail.com   
Contact: Pannarai Nasomchai, MD    +6654431169    nan-pannarai@hotmail.com   
Principal Investigator: Pornnapa Suriyachai, MD         
Principal Investigator: Pannarai Nasomchai, MD         
Buddhachinaraj Hospital Not yet recruiting
Phitsanulok, Thailand, 65000
Contact: Kanchapan Sukonpan, MD    +66 5521 9844    puimfm@gmail.com   
Contact: Narong Lertpienthum, MD    +66 5521 9844    yuident@hotmail.com   
Principal Investigator: Kanchapan Sukonpan, MD         
Principal Investigator: Narong Lertpienthum, MD         
Rayong Hospital Not yet recruiting
Rayong, Thailand, 21000
Contact: Supoj Wattanasiri, MD    +66 3861 1104    supoj007@hotmail.com   
Principal Investigator: Supoj Wattanasiri, MD         
Samutprakarn Hospital Not yet recruiting
Samut Prakan, Thailand, 10280
Contact: Lalita Songsathaporn, MD    +6627018132-9    look_pear122@hotmail.com   
Contact: Achara Puangsombat, MD    +6627018132-9    mayachara@yahoo.com   
Principal Investigator: Lalita Songsathaporn, MD         
Principal Investigator: Achara Puangsombat, MD         
Samutsakhon Hospital Not yet recruiting
Samut Sakhon, Thailand, 74000
Contact: Chatdao Sujarit, MD    +6634427099-104    csutjarit@yahoo.com   
Contact: Sawitree Krikajornkitti, MD    +6634427099-104    yuiwitree@gmail.com   
Principal Investigator: Chatdao Sujarit, MD         
Principal Investigator: Sawitree Krikajornkitti, MD         
Songkhla Hospital Not yet recruiting
Songkhla, Thailand, 90100
Contact: Benjawan Thayanithikun, MD    +66 7444 7607    bent14034@gmail.com   
Contact: Eakaphop Uthaisaeng, MD    +66 7444 7607    ekapop.u@hotmail.com   
Principal Investigator: Benjawan Thayanithikun, MD         
Principal Investigator: Eakaphop Uthaisaeng, MD         
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Principal Investigator: Gonzague Jourdain, MD, PhD Institut de Recherche pour l e Développement
  Study Documents (Full-Text)

Documents provided by GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement:
Informed Consent Form  [PDF] November 4, 2017
Study Protocol  [PDF] November 4, 2017

More Information

Responsible Party: GONZAGUE JOURDAIN, Director of the Research Unit UMI 174-PHPT, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT03343431     History of Changes
Other Study ID Numbers: iTAP-2
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

We are willing to share our data with other investigators, for example for meta-analysis, in order to answer important research questions requiring large datasets. Data-sharing agreements will include: an approval of the research plan by appropriate ethics committees, a commitment to using data for research purposes only and to securing the data or/and the samples using appropriate methods. We will consult as needed with the funding agency the practical aspects of data sharing.

Data used in publications will be released in a timely manner. De-identified study data could be accessible through a website that allows querying such as the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub or DASH (dash.nichd.nih.gov/).

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement:
Hepatitis B
Hepatitis B eAg

Additional relevant MeSH terms:
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
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