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| ID | Type | Description | Link |
|---|---|---|---|
| U01HD071889 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Centers for Disease Control and Prevention | FED |
| Gilead Sciences | INDUSTRY |
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Chronic hepatitis B (CHB) infection is complicated by cirrhosis and liver cancer. In Thailand, 7% of adults are chronically infected by Hepatitis B virus (HBV). The risk of perinatal transmission of HBV is about 12% when a mother has a high HBV load in her plasma, even if her infant receive specific immunoglobulin and vaccine.
The hypothesis of this study is that a potent antiviral, tenofovir, can decrease HBV load in HBV infected pregnant women and therefore reduce the risk of perinatal transmission/ Pregnant women participating in this study will receive tenofovir or placebo during the last trimester of pregnancy and two months postpartum. The risk of perinatal transmission will be compared between the two groups.
The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.
This is a phase III, placebo controlled, double blind, randomized clinical trial to assess the efficacy and safety of tenofovir disoproxil fumarate (TDF) given from 28 weeks' gestation until 2 months postpartum to pregnant women with Hepatitis B (HB) virus (HBV) chronic infection and positive for HB s and e antigen to prevent perinatal transmission of HBV to their infants. All infants will receive HBV passive (HB specific immunoglobulin) and active (vaccine) immunization.
Chronic hepatitis B (CHB) infection is complicated by cirrhosis and hepatocellular carcinoma (HCC), the 10th leading cause of death worldwide.
In 2011, about 7% of adults in Thailand were HBsAg carriers. Infant hepatitis B (HB) immunization and HB immune globulin (HBIg) administered at birth effectively prevent most mother-to-child transmission (MTCT) of HBV. However, about 12% of mothers with high load of HBV transmit the virus to their infants, despite active and passive immunization.
Studies have suggested that antiviral treatment at the end of pregnancy and during early postpartum can reduce the risk of transmission to the child. A potential limitation to this approach is the risk of hepatic disease exacerbation following discontinuation of antiviral treatment postpartum, and this risk has not been properly evaluated. No randomized clinical trials have adequately demonstrated the efficacy and safety of maternal antiviral treatment the prevention of mother to child transmission of HBV. This is the reason why this approach is not currently recommended by the Associations for the Study of Liver Diseases.
We hypothesize that a potent antiviral, tenofovir, can decrease HBV viral load in HBV infected pregnant women and therefore reduce the risk of perinatal transmission, before infants are definitely protected by passive-active immunization. We also hypothesize that only moderate exacerbations of liver disease will be observed after discontinuation of a short antiviral course (5 months). While the primary objective of the study is to assess the efficacy of tenofovir versus placebo for the prevention of perinatal transmission, an important secondary objective is the assessment of the risk of postpartum hepatic disease exacerbation.
Within 2 years, 328 women and their infants will be enrolled from public hospitals in Thailand and randomized to receive either tenofovir disoproxil fumarate or matching placebo from 28 weeks of pregnancy until 2 months postpartum. Mothers and infants will be followed until one year postpartum.
The primary endpoint will be the detection of HBsAg and HBV DNA in infants at six months of life. An interim analysis will be conducted when half of the outcomes are available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir disoproxil fumarate | Experimental | tenofovir disoproxil fumarate, 300 mg tablets |
|
| Placebo | Placebo Comparator | matching placebo (of tenofovir disoproxil fumarate) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tenofovir disoproxil fumarate | Drug | administration: tablet 300 mg, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Infants With Hepatitis B Infection at 6 Months of Age | Infection is defined as a HBsAg positive test confirmed by detectable HBV DNA | 6 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | Occurrence of maternal and infant adverse events, including maternal and infants Serious Adverse Events (as defined by the International Conference on Harmonization Good Clinical Practice) and NIH Division of AIDS grade 3/4 signs and symptoms, regardless of their relatedness to the study treatment. | from enrollment (28 weeks' gestation) to 12 months postpartum |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gonzague Jourdain, MD, PhD | Institut de Recherche pour le Developpement | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banglamung Hospital | Bang Lamung | Changwat Chon Buri | 20150 | Thailand | ||
| Chiang Kham Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27506549 | Background | Jourdain G, Ngo-Giang-Huong N, Cressey TR, Hua L, Harrison L, Tierney C, Salvadori N, Decker L, Traisathit P, Sirirungsi W, Khamduang W, Bowonwatanuwong C, Puthanakit T, Siberry GK, Watts DH, Murphy TV, Achalapong J, Hongsiriwon S, Klinbuayaem V, Thongsawat S, Chung RT, Pol S, Chotivanich N. Prevention of mother-to-child transmission of hepatitis B virus: a phase III, placebo-controlled, double-blind, randomized clinical trial to assess the efficacy and safety of a short course of tenofovir disoproxil fumarate in women with hepatitis B virus e-antigen. BMC Infect Dis. 2016 Aug 9;16:393. doi: 10.1186/s12879-016-1734-5. | |
| Result | Jourdain G, Ngo-Giang-Huong N, Harrison L, Decker L, Tierney C, Cressey TR, Achalapong J, Siberry GK, Nelson NP, and Chotivanich N. TDF to prevent perinatal hepatitis B virus transmission: a randomized trial (iTAP). Conference on Retroviruses and Opportunistic Infections (CROI) Abstract 584LB; 2017 February 13; Seattle, WA, USA. http://www.croiconference.org/sessions/tdf-prevent-perinatal-hepatitis-b-virus-transmission-randomized-trial-itap | ||
| 29514030 |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Pending completion of analysis planned in the protocol
Not provided
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Study Enrollment Dates: January 8, 2013 to August 19, 2015 in 17 hospital based antenatal care and pediatrics departments in Thailand
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tenofovir Disoproxil Fumarate | tenofovir disoproxil fumarate, 300 mg tablets tenofovir disoproxil fumarate: administration: tablet 300 mg, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 20, 2015 | May 8, 2020 |
Not provided
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|
| placebo | Drug | administration: one tablet, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum |
|
| Percentage of Participants With Flares After Study Treatment Interruption | Flare, or acute exacerbation of hepatitis B, after study treatment interruption is defined as an Alanine Aminotransferase plasma level above 300 IU/mL | Following planned discontinuation of study treatment up to 12 months postpartum |
| Percentage of Infants With Hepatitis B Infection at or After 6 Months Through 12 Months of Age | Infants will be considered HBV infected if at any time point at or after 6 months through 12 months of age, a sample tests positive for HBsAg and HBV DNA | at or after 6 months through 12 months of age |
| Weight, Height and Head Circumference for Age | Weight, length/height and head circumference WHO Z scores are measures of relative weight, height and head circumference adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. | assessed at 6 months and 12 months of age, 6 months reported |
| Chiang Kham |
| Changwat Phayao |
| 56110 |
| Thailand |
| Mae Chan Hospital | Mae Chan | Chiangrai | 57110 | Thailand |
| Maharat Nakhon Ratchasima Hospital | Nakhon Ratchasima | Nakhon Ratchasrima | 30000 | Thailand |
| Bhumibol Adulyadej Hospital | Bangkok | 10220 | Thailand |
| Nopparat Rajathanee Hospital | Bangkok | 10230 | Thailand |
| Prapokklao Hospital | Chanthaburi | 22000 | Thailand |
| Health Promotion Center Region 10 | Chiang Mai | 50100 | Thailand |
| Nakornping Hospital | Chiang Mai | 50180 | Thailand |
| Chiangrai Prachanukroh Hospital | Chiang Rai | 57000 | Thailand |
| Chonburi Regional Hospital | Chon Buri | 20000 | Thailand |
| Khon Kaen Hospital | Khon Kaen | 40000 | Thailand |
| Lampang Hospital | Lampang | 52000 | Thailand |
| Lamphun Hospital | Lamphun | 51000 | Thailand |
| Samutprakarn Hospital | Mueang Samut Prakan | 10280 | Thailand |
| Phayao Provincial Hospital | Phayao | 56000 | Thailand |
| Samutsakhon Hospital | Samut Sakhon | 74000 | Thailand |
| Result |
| Jourdain G, Ngo-Giang-Huong N, Harrison L, Decker L, Khamduang W, Tierney C, Salvadori N, Cressey TR, Sirirungsi W, Achalapong J, Yuthavisuthi P, Kanjanavikai P, Na Ayudhaya OP, Siriwachirachai T, Prommas S, Sabsanong P, Limtrakul A, Varadisai S, Putiyanun C, Suriyachai P, Liampongsabuddhi P, Sangsawang S, Matanasarawut W, Buranabanjasatean S, Puernngooluerm P, Bowonwatanuwong C, Puthanakit T, Klinbuayaem V, Thongsawat S, Thanprasertsuk S, Siberry GK, Watts DH, Chakhtoura N, Murphy TV, Nelson NP, Chung RT, Pol S, Chotivanich N. Tenofovir versus Placebo to Prevent Perinatal Transmission of Hepatitis B. N Engl J Med. 2018 Mar 8;378(10):911-923. doi: 10.1056/NEJMoa1708131. |
| Result | Jourdain G, Harrison LJ, Ngo-Giang-Huong N, Cressey TR, Decker L, Tierney C, Achalapong J, Kanjanavikai P, Luvira A, Srirompotong U, Murphy TV, Nelson N, Siberry GK, Pol S, for the iTAP Study Group. iTAP trial: maternal and infant efficacy and safety results 12 months after delivery. CROI, 4-7 March 2018, Boston, USA. #1316, Oral Presentation O-11 |
| Result | Salvadori N, Fan B, Teeyasoontranon W, Ngo-Giang-Huong N, Phanomcheong S, Luvira A, Puangsombat A, Suwannarat A, Srirompotong U, Putiyanun C, Kourtis A, Bulterys M, Siberry GK, Jourdain G. TDF prophylaxis for PMTCT of HBV: effect on maternal and infant bone mineral density. CROI, 4-7 March 2018, Boston, USA. #1174. Poster and Themed Discussion TD-09 |
| 30275094 | Result | Cressey TR, Harrison L, Achalapong J, Kanjanavikai P, Patamasingh Na Ayudhaya O, Liampongsabuddhi P, Siriwachirachai T, Putiyanun C, Suriyachai P, Tierney C, Salvadori N, Chinwong D, Decker L, Tawon Y, Murphy TV, Ngo-Giang-Huong N, Siberry GK, Jourdain G; iTAP Study Team. Tenofovir Exposure during Pregnancy and Postpartum in Women Receiving Tenofovir Disoproxil Fumarate for the Prevention of Mother-to-Child Transmission of Hepatitis B Virus. Antimicrob Agents Chemother. 2018 Nov 26;62(12):e01686-18. doi: 10.1128/AAC.01686-18. Print 2018 Dec. |
| 30924492 | Result | Salvadori N, Fan B, Teeyasoontranon W, Ngo-Giang-Huong N, Phanomcheong S, Luvira A, Puangsombat A, Suwannarat A, Srirompotong U, Putiyanun C, Cressey TR, Decker L, Khamduang W, Harrison L, Tierney C, Shepherd JA, Kourtis AP, Bulterys M, Siberry GK, Jourdain G. Maternal and Infant Bone Mineral Density 1 Year After Delivery in a Randomized, Controlled Trial of Maternal Tenofovir Disoproxil Fumarate to Prevent Mother-to-child Transmission of Hepatitis B Virus. Clin Infect Dis. 2019 Jun 18;69(1):144-146. doi: 10.1093/cid/ciy982. |
| Result | Ngo-Giang-Huong N, Salvadori N, Khamduang W, Cressey TR, Harrison LJ, Decker L, Tierney C, Jullapong A, Murphy TV, Nelson N, Siberry GK, Chung RT, Pol S, Jourdain G. Hepatitis B virus DNA level changes in HBeAg+ pregnant women receiving TDF for PMTCT. Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 4-7 Mar 2019 |
| Result | Bukkems V, Smolders E, Jourdain G, Hawkins D, Achalapong J, Kanjanavikai P, Taylor G, Prommas S, Burger D, Colbers A, Cressey TR, for the iTAP Study Team & PANNA network. Tenofovir plasma concentrations in pregnant women: comparison of hepatitis B and HIV-infected patients. 20th International Workshop on Clinical Pharmacology of HIV, Hepatitis & Other Antiviral Drugs. Noordwijk, the Netherlands, 14-16-May 2019 |
| Result | Jourdain G, Traisathit P, Salvadori N, Wangsaeng N, Khamduang W, Ngo-Giang-Huong N, for the iTAP Study Group. Immunization response in infants born to HBsAg+ and HBeAg+ mothers receiving TDF (ID 3681). Conference on Retroviruses and Opportunistic Infections (CROI), Hynes Convention Center, USA, 8-11 Mar 2020, Virtual Conference |
matching placebo (of tenofovir disoproxil fumarate)
placebo: administration: one tablet, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum
| COMPLETED |
|
| NOT COMPLETED |
|
Mothers only
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tenofovir Disoproxil Fumarate | tenofovir disoproxil fumarate, 300 mg tablets tenofovir disoproxil fumarate: administration: tablet 300 mg, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum |
| BG001 | Placebo | matching placebo (of tenofovir disoproxil fumarate) placebo: administration: one tablet, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Gestational age at enrollment | Median | Inter-Quartile Range | weeks |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Infants With Hepatitis B Infection at 6 Months of Age | Infection is defined as a HBsAg positive test confirmed by detectable HBV DNA | Participants in the primary analysis | Posted | Count of Participants | Participants | 6 months of age |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events | Occurrence of maternal and infant adverse events, including maternal and infants Serious Adverse Events (as defined by the International Conference on Harmonization Good Clinical Practice) and NIH Division of AIDS grade 3/4 signs and symptoms, regardless of their relatedness to the study treatment. | Mother-infant pairs | Posted | Count of Participants | Participants | from enrollment (28 weeks' gestation) to 12 months postpartum |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Flares After Study Treatment Interruption | Flare, or acute exacerbation of hepatitis B, after study treatment interruption is defined as an Alanine Aminotransferase plasma level above 300 IU/mL | Women who had delivered | Posted | Count of Participants | Participants | Following planned discontinuation of study treatment up to 12 months postpartum |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Infants With Hepatitis B Infection at or After 6 Months Through 12 Months of Age | Infants will be considered HBV infected if at any time point at or after 6 months through 12 months of age, a sample tests positive for HBsAg and HBV DNA | infants until 12 months of age | Posted | Count of Participants | Participants | at or after 6 months through 12 months of age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Weight, Height and Head Circumference for Age | Weight, length/height and head circumference WHO Z scores are measures of relative weight, height and head circumference adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. | infants at 6 months of age | Posted | Mean | Standard Deviation | Z-score | assessed at 6 months and 12 months of age, 6 months reported |
|
|
From enrollment (28 weeks' gestation) to 12 months postpartum
Adverse event information was collected using the same definitions of adverse event and serious adverse event as the clinicaltrials.gov definitions. Only serious adverse events and other (not including serious) Grade 3 or 4 adverse events are reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tenofovir Disoproxil Fumarate | tenofovir disoproxil fumarate, 300 mg tablets tenofovir disoproxil fumarate: administration: tablet 300 mg, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum | 0 | 331 | 62 | 331 | 42 | 331 |
| EG001 | Placebo | matching placebo (of tenofovir disoproxil fumarate) placebo: administration: one tablet, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum | 0 | 323 | 66 | 323 | 31 | 323 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Glucose-6-phosphate dehydrogenase deficiency | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hemivertebra | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Multiple congenital abnormalities | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Talipes | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia neonatal | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bacterial diarrhoea | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Endometritis decidual | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Omphalitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Treponema test positive | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| False labour | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| |
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| |
| Premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| |
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| |
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| |
| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| |
| Uterine inflammation | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Meconium aspiration syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neonatal asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Transient tachypnoea of the newborn | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Persistent foetal circulation | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Neutrophil count abnormal | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cerebral atrophy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Breech presentation | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| |
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| |
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| |
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| |
| Retained placenta or membranes | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gonzague Jourdain | French National Research Institute for Sustainable Development (IRD) | +66818830065 | gonzague.jourdain@ird.fr |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2016 | May 8, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|