Hepatitis B Chronic InfectionPhase 4TA-PROHMNCT02937779
Tenofovir As Prevention Of Hepatitis b Mother-to-child Transmission
A Phase 4 study testing Tenofovir disoproxil fumarate and Rapid tests HBe Ag in people with Hepatitis B Chronic Infection and Pregnancy, run by ANRS, Emerging Infectious Diseases at 3 sites in Cambodia.
Trial summary
The World Health Organization recommends that all high endemic countries for HBV infection based their mother to child transmission prevention strategies on vaccination of all children and administration of immunoglobulins (HBIG) to infants born to infected mothers in the first 24 hours after birth. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hepatitis B Chronic Infection, Pregnancy
- What is being tested?
- Tenofovir disoproxil fumarate and Rapid tests HBe Ag
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 933 participants
- Where
- 3 sitesCambodia
- Study dates
- 4 Oct 2017to 31 Mar 2020
- Phase
- Phase 4
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- >= 18 years old the day of inclusion
- Pregnancy
- Positive HBs Ag
- Informed consent obtained with information sheet given and explained and the consent form signed by the participant of the project investigator at the latest the day of the inclusion
Who cannot join
- Women refusing HBs Ag test
- HIV co-infection
- HCV co-infection
- HBV treatment ongoing at the day of inclusion
- Creatinine clearance < 30 mL/min
- Severe gravidic disease present at inclusion involving life threatening to the mother and/or the child
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- Evidence of pre-existing fetal anomalies incompatible with the child's life
- Imminent child's birth defined as cervix dilatation up to 7 centimeters
- Intention to deliver in a maternity not linked to the study
- Any concomitant medical condition that, according to the clinical site investigator would contraindicate participation in the study.
- Concurrent participation in any other clinical trial without written agreement of the two study teams
Trial locations and contacts
3 sites in 1 country.
Cambodia3 sites
Kampong Cham Provincial Hospital
Kampong Cham
Calmette Hospital
Phnom Penh
National Mother and Child Health Center
Phnom Penh
About this study
The World Health Organization recommends that all high endemic countries for HBV infection based their mother to child transmission prevention strategies on vaccination of all children and administration of immunoglobulins (HBIG) to infants born to infected mothers in the first 24 hours after birth. Lack of access to antenatal screening and to HBIG significantly results in failure of this strategy in many countries. Moreover, despite sero-vaccination, 10 to 15% of infants of mothers that are positive for HBsAg and HBeAg are still infected, as high levels of HBV replication occurring in the third quarter of pregnancy act as a major risk factor.
The objective of this study is to assess the effectiveness of an operational strategy to prevent HBV mother-to-child transmission (MTCT) in Cambodia based on the use of rapid tests HBs Ag and HBe Ag to screen HBV infection and a treatment by TDF for patients with a positive HBeAg test with a "test and treat" strategy for those seen for Antenatal Care (ANC) from 24 weeks of amenorrhea. In all cases, vaccination of the newborn will be carried out according to the national protocol in Cambodia i.e. 4 injections at 24 hours, 6, 10 and 14 weeks of age.
Read more
A phase IV multicenter observational and interventional non randomized prospective study will be conducted in 4 maternity in Cambodia.
The primary outcome will be the proportion of active HBV infection in new-born at 6 months of life estimated by HBs Ag positivity.
The study will aim to document the acceptability and the operational implementation of the study using rapid tests usable in all health centers and a drug available in all the country thanks to HIV national program. The results will be helpful for Cambodian government in order to implement guidelines and algorithm follow-up for HBV-infected pregnant women.
Read the detailed description
Principal objective: Assess the effectiveness of a strategy to prevent HBV mother-to-child transmission (MTCT) in Cambodia based on the use of rapid tests HBs Ag and HBe Ag to screen HBV infection and a treatment by TDF for patients with a positive HBeAg test with a "test and treat" strategy for those seen for Antenatal Care (ANC) from 24 weeks of amenorrhea.
Secondary objectives Assess the feasibility and acceptability for patients and health care providers of the rapid tests screening strategy Assess the acceptability of the test and treat strategy for patients seen after 24 weeks of amenorrhea Describe the HBV viral load (VL) decrease caused by the TDF Estimate the rate of HBV transmission to newborns according to the time spent on TDF as well as initial viral load level and delivery viral load level Estimate the rate of HBV transmission to newborns for HBe Ag negative women Describe the correlation between HBV viral load level and HBe Ag status Describe subgroups of mothers and new-borns for which the strategy seems more effective Assess TDF safety in mothers Analyse the cost-effectiveness of the strategy compare to international guidelines (WHO, APASL)
Each woman will be informed of the objectives and the total duration of the study as well as the benefits and risks to participate. An information sheet in Khmer will be given to each woman. The study will be composed of two phases of information's and consent. The first one will be done during the HBs Ag screening using rapid test; the screening will be proposed to all pregnant women attending ANC in one of the affiliated centres. The second phase will be done during the inclusion visit and will concern only HBs Ag positive women. The study will concern only HBs Ag positive women with 1) follow up of all HBsAg positive women from inclusion up to 6 months postpartum 2) For HBeAg positive women, initiation of treatment by fumarate de tenofovir disoproxil (Viread®), with a daily administration of one 300mg pill. Women will be treated from 24 weeks of amenorrhea until 6 weeks post-partum. For women with first ANC after 24 weeks of amenorrhea, treatment will begin the day of inclusion. Treatment will be given for 4 weeks and adherence will be estimated. In all cases, vaccination of the newborn will be carried out according to the national protocol in Cambodia i.e. 4 injections at 24 hours, 6, 10 and 14 weeks of age.
A total of 933 positive HBs Ag pregnant women will be enrolled including 280 HBe Ag positive women and 653 HBe negative women.
- Conditions
- Hepatitis B Chronic Infection, Pregnancy
- Being tested
- Tenofovir disoproxil fumarate, Rapid tests HBe Ag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxil fumarateDrug
Also called TDF
tenofovir disoproxil fumarate 300 mg one tablet once daily from 24 weeks of amennorrhea to 6 weeks post-partum for HBe Ag positive women only.
Rapid tests HBe AgDevice
For all HBs Ag positive women
| Study group | Role | What they receive |
|---|---|---|
| HBs Ag positive | Experimental | tenofovir disoproxil fumarate 300 mg one tablet once daily from 24 weeks of amennorrhea to 6 weeks post-partum for positive Hbe Ag women.
No treatment for negative HBe Ag women Receives: Drug: Tenofovir disoproxil fumarate; Device: Rapid tests HBe Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of active HBV infection in new-born at 6 months of life
The proportion will be estimated by HBs Ag positivity
Measured: 6 months post-partum
Secondary outcomes (4)
Process and acceptability of the screening phase
Proportion of women with screening proposed among those eligible in antenatal consultation (ANC)
Measured: Enrollement
Process and acceptability of the screening phase
Proportion of women with a done screening among those to whom screening was proposed
Measured: Enrollement
Process and acceptability of the screening phase
Proportion of women with a given results in less than one day among those to whom the test was made
Measured: Enrollement
Process and acceptability of the screening phase
Care-giver satisfaction regarding the strategy (estimated by questionnaires)
Measured: Enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start4 Oct 2017
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B Chronic InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 933 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Samsorphea CHHUN, MD, Principal investigator, Calmette Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937779
- Sponsor's protocol ID
- ANRS 12345
- Acronym
- TA-PROHM
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2016
- Last updated
- 16 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Segeral O, Dim B, Durier C, Nhoueng S, Chhim K, Sovann S, Yom S, Vong C, Yin S, Ros B, Ky V, Pech S, Nem B, Hout K, Guillebaud J, Ear E, Caroupaye-Caroupin L, Rekacewicz C, Fernandez L, Laurent D, Yay C, Kim R, Meyer L, Chhun S; Laurence Borand for the ANRS-MIE TA PROHM Study Group. Immunoglobulin-free strategy to prevent HBV mother-to-child transmission in Cambodia (TA-PROHM): a single-arm, multicentre, phase 4 trial. Lancet Infect Dis. 2022 Aug;22(8):1181-1190. doi: 10.1016/S1473-3099(22)00206-7. Epub 2022 May 25.
PubMed 35643089
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenofovir As Prevention Of Hepatitis b Mother-to-child Transmission
- ClinicalTrials.gov ID
- NCT02937779
- Acronym / sponsor ID
- TA-PROHM / ANRS 12345
- Conditions
- Hepatitis B Chronic Infection, Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 933 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 19 Oct 2016 (estimated)
- 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.
The World Health Organization recommends that all high endemic countries for HBV infection based their mother to child transmission prevention strategies on vaccination of all children and administration of immunoglobulins (HBIG) to infants born to infected mothers in the first 24 hours after birth. Lack of access to antenatal screening and to HBIG significantly results in failure of this strategy in many countries. Moreover, despite sero-vaccination, 10 to 15% of infants of mothers that are positive for HBsAg and HBeAg are still infected, as high levels of HBV replication occurring in the third quarter of pregnancy act as a major risk factor.
The objective of this study is to assess the effectiveness of an operational strategy to prevent HBV mother-to-child transmission (MTCT) in Cambodia based on the use of rapid tests HBs Ag and HBe Ag to screen HBV infection and a treatment by TDF for patients with a positive HBeAg test with a "test and treat" strategy for those seen for Antenatal Care (ANC) from 24 weeks of amenorrhea. In all cases, vaccination of the newborn will be carried out according to the national protocol in Cambodia i.e. 4 injections at 24 hours, 6, 10 and 14 weeks of age.
A phase IV multicenter observational and interventional non randomized prospective study will be conducted in 4 maternity in Cambodia.
The primary outcome will be the proportion of active HBV infection in new-born at 6 months of life estimated by HBs Ag positivity.
The study will aim to document the acceptability and the operational implementation of the study using rapid tests usable in all health centers and a drug available in all the country thanks to HIV national program. The results will be helpful for Cambodian government in order to implement guidelines and algorithm follow-up for HBV-infected pregnant women.
Detailed description
Principal objective: Assess the effectiveness of a strategy to prevent HBV mother-to-child transmission (MTCT) in Cambodia based on the use of rapid tests HBs Ag and HBe Ag to screen HBV infection and a treatment by TDF for patients with a positive HBeAg test with a "test and treat" strategy for those seen for Antenatal Care (ANC) from 24 weeks of amenorrhea.
Secondary objectives Assess the feasibility and acceptability for patients and health care providers of the rapid tests screening strategy Assess the acceptability of the test and treat strategy for patients seen after 24 weeks of amenorrhea Describe the HBV viral load (VL) decrease caused by the TDF Estimate the rate of HBV transmission to newborns according to the time spent on TDF as well as initial viral load level and delivery viral load level Estimate the rate of HBV transmission to newborns for HBe Ag negative women Describe the correlation between HBV viral load level and HBe Ag status Describe subgroups of mothers and new-borns for which the strategy seems more effective Assess TDF safety in mothers Analyse the cost-effectiveness of the strategy compare to international guidelines (WHO, APASL)
Each woman will be informed of the objectives and the total duration of the study as well as the benefits and risks to participate. An information sheet in Khmer will be given to each woman. The study will be composed of two phases of information's and consent. The first one will be done during the HBs Ag screening using rapid test; the screening will be proposed to all pregnant women attending ANC in one of the affiliated centres. The second phase will be done during the inclusion visit and will concern only HBs Ag positive women. The study will concern only HBs Ag positive women with 1) follow up of all HBsAg positive women from inclusion up to 6 months postpartum 2) For HBeAg positive women, initiation of treatment by fumarate de tenofovir disoproxil (Viread®), with a daily administration of one 300mg pill. Women will be treated from 24 weeks of amenorrhea until 6 weeks post-partum. For women with first ANC after 24 weeks of amenorrhea, treatment will begin the day of inclusion. Treatment will be given for 4 weeks and adherence will be estimated. In all cases, vaccination of the newborn will be carried out according to the national protocol in Cambodia i.e. 4 injections at 24 hours, 6, 10 and 14 weeks of age.
A total of 933 positive HBs Ag pregnant women will be enrolled including 280 HBe Ag positive women and 653 HBe negative women.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBs Ag positive | Experimental | Drug: Tenofovir disoproxil fumarate, Device: Rapid tests HBe Agtenofovir disoproxil fumarate 300 mg one tablet once daily from 24 weeks of amennorrhea to 6 weeks post-partum for positive Hbe Ag women. No treatment for negative HBe Ag women |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- >= 18 years old the day of inclusion
- Pregnancy
- Positive HBs Ag
- Informed consent obtained with information sheet given and explained and the consent form signed by the participant of the project investigator at the latest the day of the inclusion
Key exclusion criteria (11 listed)
- Women refusing HBs Ag test
- HIV co-infection
- HCV co-infection
- HBV treatment ongoing at the day of inclusion
- Creatinine clearance < 30 mL/min
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 fumarateAlso: TDFtenofovir disoproxil fumarate 300 mg one tablet once daily from 24 weeks of amennorrhea to 6 weeks post-partum for HBe Ag positive women only. | Drug | HBs Ag positive |
| Rapid tests HBe AgFor all HBs Ag positive women | Device | HBs Ag positive |
Primary outcome
Proportion of active HBV infection in new-born at 6 months of life
Time frame: 6 months post-partum
The proportion will be estimated by HBs Ag positivity
4 secondary outcomes
Process and acceptability of the screening phase
Time frame: Enrollement
Process and acceptability of the screening phase
Time frame: Enrollement
Process and acceptability of the screening phase
Time frame: Enrollement
Process and acceptability of the screening phase
Time frame: Enrollement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Derived from this study: PubMed 35643089Segeral O, Dim B, Durier C, Nhoueng S, Chhim K, Sovann S, Yom S, Vong C, Yin S, Ros B, Ky V, Pech S, Nem B, Hout K, Guillebaud J, Ear E, Caroupaye-Caroupin L, Rekacewicz C, Fernandez L, Laurent D, Yay C, Kim R, Meyer L, Chhun S; Laurence Borand for the ANRS-MIE TA PROHM Study Group. Immunoglobulin-free strategy to prevent HBV mother-to-child transmission in Cambodia (TA-PROHM): a single-arm, multicentre, phase 4 trial. Lancet Infect Dis. 2022 Aug;22(8):1181-1190. doi: 10.1016/S1473-3099(22)00206-7. Epub 2022 May 25.
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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.
Samsorphea CHHUN, MD principal investigator
Calmette Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir disoproxil fumarate and Rapid tests HBe Ag in people with Hepatitis B Chronic Infection and Pregnancy, run by ANRS, Emerging Infectious Diseases at 3 sites in Cambodia.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cambodia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Proportion of active HBV infection in new-born at 6 months of life (time frame: 6 months post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02937779, which also lists 1 linked publication.
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 16 Oct 2019.