Hepatitis BPhase 2PK-TDFNCT04114890
Tenofovir in Pregnancy to Prevent Mother to Child Transmission of Hepatitis B.
A Phase 2 study testing Tenofovir Disoproxil Fumarate in people with Hepatitis B and Tenofovir, run by University of Oxford at 1 site in Thailand.
Trial summary
Hepatitis B virus (HBV) can be asymptomatic for years but can also lead to chronic hepatitis, hepatocellular carcinoma, and liver failure and death and cannot be eradicated with the current therapy. Chronic maternal HBV infection is an important source of perinatal transmission in regions of high HBV prevalence. Read more about this study
- Who is it for?
- Ages 16 to 49 years, women only
- Conditions the study is for
- Hepatitis B, Tenofovir, Pregnancy
- What is being tested?
- Tenofovir Disoproxil Fumarate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteThailand
- Study dates
- 8 Jan 2021to 29 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Single viable pregnancy at enrollment day
- Estimated Gestational Age (EGA) 20-<24 weeks for 2nd trimester or EGA 28-<34 for 3rd trimester
- Willing and able to give informed consent for participation in the study
- Hepatitis B infected (HBsAg and HBeAg confirmed positive or HBsAg confirmed positive and HBV DNA detected in HBeAg negative)
- Burmese and Karen female, 16-49 years (inclusive)
- Willing to take TDF daily during pregnancy
- Plans to deliver at SMRU clinics
Who cannot join
- Undetectable HBV DNA in HBeAg negative women
- HIV infected or other chronic illness incompatible with the study requirements or receiving Immunosuppressive therapy
- Creatinine at screening >1 mg/dL
- Serum phosphate <2.4 mg/dL
- History of chronic kidney disease
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Shoklo Malaria Research unit (SMRU) clinics
Mae Sot, Changwat Tak, 63110
About this study
Official title: The Pharmacokinetic Parameters of Tenofovir (TFV) in Maternal Blood and Breast Milk in Women Treated With Daily Tenofovir Disoproxil Fumarate (TDF; 300mg) for Prevention of Mother to Child Transmission (PMTCT) of Hepatitis B Virus (HBV) Mono-infection
Hepatitis B virus (HBV) can be asymptomatic for years but can also lead to chronic hepatitis, hepatocellular carcinoma, and liver failure and death and cannot be eradicated with the current therapy. Chronic maternal HBV infection is an important source of perinatal transmission in regions of high HBV prevalence. In antenatal clinics at Shoklo Malaria Research Unit (SMRU), the Hepatitis B (HB) surface antigen (sAg) prevalence is 8.3% with a HB e-antigen (HBeAg) prevalence of 32.7% in those positive for HBsAg in 2012-2014. Perinatal infection occurs in 70-90% of women with HBeAg positive chronic HBV compared with 0-30% in those with HBeAg negative chronic HBV (inactive carriers). These infection rates reflect, in part, the failure of maternal and child health programs to prevent perinatal transmission with hepatitis B immunoglobulin (HBIG) and HB vaccines. Prevention of mother to child transmission (PMTCT) fails in an estimated 8-32% of cases with adequate preventive techniques. Antiretrovirals, like tenofovir (TFV) that is administered as the prodrug Tenofovir Disoproxil Fumarate (TDF), are active against HBV and may reduce the risk of HBV transmission at birth if offered at the right time in pregnancy.
One of the major gaps in implementing this strategy is adequate pharmacokinetic (PK) data in pregnant women that informs correct dosing. One recently published population PK study in 154 women who provided maternal blood samples (32 and 36 weeks of pregnancy, at delivery, and at 1 and 2 months post-partum) reported a tenofovir area under curve (AUC) 0-24 that was estimated to be 20% (95% CI, 19-21%) lower during pregnancy than during post-partum suggesting no dose adjustments are needed in 3rd trimester. Most PK studies for TDF in pregnancy have been for Human Immunodeficiency Virus type 1 (HIV-1) infections. However, these patients often receive additional antiretroviral medications, preventing conclusions on PK parameters of Tenofovir (TFV) alone. Doses that are optimal for HIV may not be appropriate for HBV.
Read more
When TDF is administered during pregnancy and potentially during lactation, it is important to establish the infant drug exposure. Previous human studies have shown that antiretrovirals administered to lactating mothers are present in the breast milk and have detected a low TDF breast milk concentration representing 0.03% or less of the proposed infant dosage. However, there is no data on this subject in therapeutic treatment of HBV infected women. In resource poor settings TDF administration will be ceased after 1 month post-partum. While there is some understanding of what happens to viral load post cessation in non-pregnant individuals, post-partum TDF cessation is less well understood and may be affected by differences in immunity. With breastmilk as the primary source of nutrition for babies in resource limited settings, it is important to know the viral exposure from breastmilk, if any, as these settings may also have problems achieving birth dose, HBIG and completion of the recommended three doses of vaccine.
The investigators propose a dense PK study of once daily TDF 300 mg during pregnancy given for PMTCT of HBV mono-infection. Tenofovir PK will be measured in maternal blood samples in steady-state, in the 2nd and 3rd trimesters and post-partum. The presence of HBV DNA in blood and breast milk will also be explored in women after cessation of treatment until 6 months post-partum.
Read the detailed description
Participants with HBV mono infection and a measurable HBV DNA viral load attending SMRU antenatal clinics (ANC) on the Myanmar-Thailand border will be invited if they have a gestational age of at least 20 weeks. A total of 24 women: 12 participants enrolled in 2nd trimester (EGA 20-<24 weeks) and 12 enrolled in 3rd trimester (EGA 28-<36) with complete samples are required.
Women, identified by routine antenatal care screening for HBV will be invited to participate if they are HBsAg positive and meet the inclusion and exclusion criteria. Participants will be provided TDF 300mg daily and will continue TDF treatment until one month after delivery. The TFV concentrations will be measured monthly before delivery, at delivery, in cord blood and 1 and 2 months postpartum. Additional dense PK blood sampling will be done in the second and third trimester and postpartum. Breast milk samples timed with mother blood and infant blood samples will be included to measure drug concentrations in breastmilk as possible presence of HBV DNA viral in breastmilk following cessation of TDF.
The dense sampling for pharmacokinetics assessments will occur at least after 2 weeks of TDF treatment in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks postpartum. The dense sampling will entail twelve blood samples in a 24 hour period (24ml of blood in total). Women will be counseled about the importance of adherence. Direct Observed Treatment (DOT) in the 3 days prior to the dense blood sampling will be performed. The woman can choose to be admitted for these days or if a home visitor lives close enough be supervised at home.
The follow-up for women will be until 6 months post-partum, to check for flares. TFV concentrations will be collected by venous blood testing but an indwelling catheter can be used during the rich sampling 24 hour period. Infants will be followed up from delivery, and at 1, 2, 4 and 6 months of age for vaccination and growth. Infant drug exposure is measured at month 1 and HBV DNA will be measured at birth from cord blood and HBsAg by venepuncture at 2 months of age.
Funder \& grant reference number: iTPA Award (grant ref. no. WT-iTP-2019/006)
- Conditions
- Hepatitis B, Tenofovir, Pregnancy
- Being tested
- Tenofovir Disoproxil Fumarate
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil FumarateDrug
Tenofovir Disoproxil Fumarate 300 mg once daily and will continue until one month after delivery
| Study group | Role | What they receive |
|---|---|---|
| Pregnant woman with second trimester and third trimester | Experimental | Not described Receives: Drug: Tenofovir Disoproxil Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve [AUC]
Measured: At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.
Maximum (peak) plasma drug concentration [Cmax]
Measured: At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.
Minimum plasma drug concentration [Cmin]
Measured: At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.
Initial (fictive) or back-extrapolated plasma drug concentration at time zero [C0]
Measured: At pre-dose (in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.)
Plasma drug concentration at time 24 [C24]
Measured: At 24 hours post-dose (in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.)
Trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration]) [Cthrough]
Measured: At the end of a dosing interval at steady state
Apparent total clearance of the drug from plasma after oral administration [CL/F]
Measured: At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.
Elimination half-life [t½]
Measured: At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.
Time to reach maximum (peak) plasma concentration following drug administration [tmax]
Measured: At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.
Secondary outcomes (4)
Maternal breastmilk TFV concentrations
Measured: 1 month post-partum
Milk to maternal plasma concentration ratios (M/P)
Measured: 1 month post-partum
Infant plasma drug concentration
Measured: At 1 month of life
HBV DNA in blood and breastmilk
Measured: At delivery and 1, 2, 3, 4, 5, and 6 months post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start8 Jan 2021
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114890
- Sponsor's protocol ID
- VIR19001
- Acronym
- PK-TDF
- Status last verified
- Jan 2024
- First submitted
- 18 Sep 2019
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Subject's clinical data and results from blood analyses stored in our database may be shared with other researchers to use in the future. However, the other researchers will not be given any information that could identify the subject.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetic Parameters of Tenofovir (TFV) in Maternal Blood and Breast Milk in Women Treated With Daily Tenofovir Disoproxil Fumarate (TDF; 300mg) for Prevention of Mother to Child Transmission (PMTCT) of Hepatitis B Virus (HBV) Mono-infection
- ClinicalTrials.gov ID
- NCT04114890
- Acronym / sponsor ID
- PK-TDF / VIR19001
- Conditions
- Hepatitis B, Tenofovir, Pregnancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatitis B virus (HBV) can be asymptomatic for years but can also lead to chronic hepatitis, hepatocellular carcinoma, and liver failure and death and cannot be eradicated with the current therapy. Chronic maternal HBV infection is an important source of perinatal transmission in regions of high HBV prevalence. In antenatal clinics at Shoklo Malaria Research Unit (SMRU), the Hepatitis B (HB) surface antigen (sAg) prevalence is 8.3% with a HB e-antigen (HBeAg) prevalence of 32.7% in those positive for HBsAg in 2012-2014. Perinatal infection occurs in 70-90% of women with HBeAg positive chronic HBV compared with 0-30% in those with HBeAg negative chronic HBV (inactive carriers). These infection rates reflect, in part, the failure of maternal and child health programs to prevent perinatal transmission with hepatitis B immunoglobulin (HBIG) and HB vaccines. Prevention of mother to child transmission (PMTCT) fails in an estimated 8-32% of cases with adequate preventive techniques. Antiretrovirals, like tenofovir (TFV) that is administered as the prodrug Tenofovir Disoproxil Fumarate (TDF), are active against HBV and may reduce the risk of HBV transmission at birth if offered at the right time in pregnancy.
One of the major gaps in implementing this strategy is adequate pharmacokinetic (PK) data in pregnant women that informs correct dosing. One recently published population PK study in 154 women who provided maternal blood samples (32 and 36 weeks of pregnancy, at delivery, and at 1 and 2 months post-partum) reported a tenofovir area under curve (AUC) 0-24 that was estimated to be 20% (95% CI, 19-21%) lower during pregnancy than during post-partum suggesting no dose adjustments are needed in 3rd trimester. Most PK studies for TDF in pregnancy have been for Human Immunodeficiency Virus type 1 (HIV-1) infections. However, these patients often receive additional antiretroviral medications, preventing conclusions on PK parameters of Tenofovir (TFV) alone. Doses that are optimal for HIV may not be appropriate for HBV.
When TDF is administered during pregnancy and potentially during lactation, it is important to establish the infant drug exposure. Previous human studies have shown that antiretrovirals administered to lactating mothers are present in the breast milk and have detected a low TDF breast milk concentration representing 0.03% or less of the proposed infant dosage. However, there is no data on this subject in therapeutic treatment of HBV infected women. In resource poor settings TDF administration will be ceased after 1 month post-partum. While there is some understanding of what happens to viral load post cessation in non-pregnant individuals, post-partum TDF cessation is less well understood and may be affected by differences in immunity. With breastmilk as the primary source of nutrition for babies in resource limited settings, it is important to know the viral exposure from breastmilk, if any, as these settings may also have problems achieving birth dose, HBIG and completion of the recommended three doses of vaccine.
The investigators propose a dense PK study of once daily TDF 300 mg during pregnancy given for PMTCT of HBV mono-infection. Tenofovir PK will be measured in maternal blood samples in steady-state, in the 2nd and 3rd trimesters and post-partum. The presence of HBV DNA in blood and breast milk will also be explored in women after cessation of treatment until 6 months post-partum.
Detailed description
Participants with HBV mono infection and a measurable HBV DNA viral load attending SMRU antenatal clinics (ANC) on the Myanmar-Thailand border will be invited if they have a gestational age of at least 20 weeks. A total of 24 women: 12 participants enrolled in 2nd trimester (EGA 20-<24 weeks) and 12 enrolled in 3rd trimester (EGA 28-<36) with complete samples are required.
Women, identified by routine antenatal care screening for HBV will be invited to participate if they are HBsAg positive and meet the inclusion and exclusion criteria. Participants will be provided TDF 300mg daily and will continue TDF treatment until one month after delivery. The TFV concentrations will be measured monthly before delivery, at delivery, in cord blood and 1 and 2 months postpartum. Additional dense PK blood sampling will be done in the second and third trimester and postpartum. Breast milk samples timed with mother blood and infant blood samples will be included to measure drug concentrations in breastmilk as possible presence of HBV DNA viral in breastmilk following cessation of TDF.
The dense sampling for pharmacokinetics assessments will occur at least after 2 weeks of TDF treatment in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks postpartum. The dense sampling will entail twelve blood samples in a 24 hour period (24ml of blood in total). Women will be counseled about the importance of adherence. Direct Observed Treatment (DOT) in the 3 days prior to the dense blood sampling will be performed. The woman can choose to be admitted for these days or if a home visitor lives close enough be supervised at home.
The follow-up for women will be until 6 months post-partum, to check for flares. TFV concentrations will be collected by venous blood testing but an indwelling catheter can be used during the rich sampling 24 hour period. Infants will be followed up from delivery, and at 1, 2, 4 and 6 months of age for vaccination and growth. Infant drug exposure is measured at month 1 and HBV DNA will be measured at birth from cord blood and HBsAg by venepuncture at 2 months of age.
Funder \& grant reference number: iTPA Award (grant ref. no. WT-iTP-2019/006)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant woman with second trimester and third trimester | Experimental | Drug: Tenofovir Disoproxil Fumarate |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Single viable pregnancy at enrollment day
- Estimated Gestational Age (EGA) 20-<24 weeks for 2nd trimester or EGA 28-<34 for 3rd trimester
- Willing and able to give informed consent for participation in the study
- Hepatitis B infected (HBsAg and HBeAg confirmed positive or HBsAg confirmed positive and HBV DNA detected in HBeAg negative)
- Burmese and Karen female, 16-49 years (inclusive)
Key exclusion criteria (5 listed)
- Undetectable HBV DNA in HBeAg negative women
- HIV infected or other chronic illness incompatible with the study requirements or receiving Immunosuppressive therapy
- Creatinine at screening >1 mg/dL
- Serum phosphate <2.4 mg/dL
- History of chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate 300 mg once daily and will continue until one month after delivery | Drug | Pregnant woman with second trimester and third trimester |
Primary outcome
Area under the plasma concentration-time curve [AUC]
Time frame: At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.
Maximum (peak) plasma drug concentration [Cmax]
Time frame: At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.
Minimum plasma drug concentration [Cmin]
Time frame: At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.
Initial (fictive) or back-extrapolated plasma drug concentration at time zero [C0]
Time frame: At pre-dose (in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.)
Plasma drug concentration at time 24 [C24]
Time frame: At 24 hours post-dose (in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.)
Trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration]) [Cthrough]
Time frame: At the end of a dosing interval at steady state
Apparent total clearance of the drug from plasma after oral administration [CL/F]
Time frame: At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.
Elimination half-life [t½]
Time frame: At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.
Time to reach maximum (peak) plasma concentration following drug administration [tmax]
Time frame: At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.
4 secondary outcomes
Maternal breastmilk TFV concentrations
Time frame: 1 month post-partum
Milk to maternal plasma concentration ratios (M/P)
Time frame: 1 month post-partum
Infant plasma drug concentration
Time frame: At 1 month of life
HBV DNA in blood and breastmilk
Time frame: At delivery and 1, 2, 3, 4, 5, and 6 months post-partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: Yes. Subject's clinical data and results from blood analyses stored in our database may be shared with other researchers to use in the future. However, the other researchers will not be given any information that could identify the subject.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tenofovir Disoproxil Fumarate in people with Hepatitis B and Tenofovir, run by University of Oxford at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve [AUC] (time frame: At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks post-partum.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.