Tenofovir As Prevention Of Hepatitis b Mother-to-child Transmission

NCT02937779 | Unknown Phase 4

• 1 other identifier: ANRS 12345
• Study Type: interventional
• Target: 933
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Hepatitis B Chronic Infection; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Proportion of active HBV infection in new-born at 6 months of life

  The proportion will be estimated by HBs Ag positivity

  6 months post-partum

Secondary Outcomes (4)

• Process and acceptability of the screening phase

  Enrollement

• Process and acceptability of the screening phase

  Enrollement

• Process and acceptability of the screening phase

  Enrollement

• Process and acceptability of the screening phase

  Enrollement

Other Outcomes (7)

• Process and acceptability of the drug's intervention

  Enrollement

• Proportion of women with viral load > 6 Log among those HBe Ag negative

  Enrollement

• Proportion of new-born with positive HBs Ag at 6 months according to treatment duration, initial and delivery viral load level

  6 months post-partum

Study Arms (1)

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

Drug: Tenofovir disoproxil fumarate; Device: Rapid tests HBe Ag

Interventions

Tenofovir disoproxil fumarate DRUG

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.

Also known as: TDF

HBs Ag positive

Rapid tests HBe Ag DEVICE

For all HBs Ag positive women

HBs Ag positive

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnancy
• Positive HBs Ag

You may not qualify if:

• Women refusing HBs Ag test
• HIV co-infection
• HCV co-infection
• Creatinine clearance \< 30 mL/min
• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (3)

Kampong Cham Provincial Hospital

Kampong Cham, Cambodia

Location

Calmette Hospital

Phnom Penh, Cambodia

Location

National Mother and Child Health Center

Phnom Penh, Cambodia

Location

Related Publications (1)

• 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.

  PMID: 35643089 DERIVED

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Samsorphea CHHUN, MD

  Calmette Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 19, 2016
• Study Start: October 4, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

CA (3)