Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
112
Countries
1
Sites
7
congenital CMV infection
This study aims to investigate the effectivity of valaciclovir to prevent vertical CMV transmission during pregnancy in first trimester primary maternal CMV infections.
Key facts
- Sponsor
- UZ Leuven
- Participant type
- Pediatric, Patients
- Age range
- In Utero, 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02], Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 19 Jun 2024 → ongoing
- Decision date (initial)
- 2023-08-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Sandoz NV · FWO TBM
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Therapy, Safety, Efficacy
This study aims to investigate the effectivity of valaciclovir to prevent vertical CMV transmission during pregnancy in first trimester primary maternal CMV infections.
Secondary objectives 4
- long-term safety of valaciclovir treatment during pregnancy in the mother and in the patient
- Increase patient awareness of CMV during pregnancy
- Standardize first trimester CMV screening for pregnant women
- Recalculate the cost-effectiveness of population screening for CMV during pregnancy in Flanders
Conditions and MedDRA coding
congenital CMV infection
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-500714-25-00 | Congenital CMV treated with valaciclovir during pregnancy: a prospective cohort study | UZ Leuven |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- 18 years or older
- Proven first trimester primary CMV infection
Exclusion criteria 4
- Participant has a history of kidney function problems, liver function problems, immunocomprimised
- Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The rate of vertical transmission, assessed by CMV PCR on amniotic fluid collected during an amniocentesis at 20w. This result will be reconfirmed by PCR on a urine sample postnatally.
Secondary endpoints 4
- Imaging abnormalities indicative for vertical transmission assed on ultrasound two weekly and on MRI at 30w GA.
- Maternal safety assessed by blood analysis (hematology, liver function, kidney function) and clinically
- Fetal safety assessed by ultrasound prenatally, blood analysis at birth on umbilical cord blood (hematology, liver function), postnatal urine sample, MRI postnatally
- Long term effects: hearing assessment yearly until year 4 and neurodevelopmental follow-up at 1,2 and 5 years of age.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Valaciclovir Sandoz 500 mg filmomhulde tabletten
PRD867040 · Product
- Active substance
- Valaciclovir
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 8 g gram(s)
- Max total dose
- 90 d day
- Max treatment duration
- 11 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AB11 — VALACICLOVIR
- Marketing authorisation
- BE341327
- MA holder
- SANDOZ N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Leuven
- Sponsor organisation
- UZ Leuven
- Address
- Herestraat 49
- City
- Leuven
- Postcode
- 3000
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Leuven
- Contact name
- Lennart Van der Veeken
Public contact point
- Organisation
- UZ Leuven
- Contact name
- Emma Van den Eede
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 112 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
UZ Leuven
Gynaecologie-Verloskunde, Herestraat 49, 3000, Leuven
Ziekenhuis Oost Limburg
Gynaecologie-Verloskunde, Synaps Park 1, 3600, Genk
UZ Brussel
Gynaecologie-Verloskunde, Laarbeeklaan 101, 1090, Jette
Gasthuiszusters Antwerpen
Gynaecologie-verlsokunde, Oosterveldlaan 24, 2610, Antwerp
Antwerp University Hospital
Gynaeoclogie-Verloskunde, Drie Eikenstraat 655, 2650, Edegem
Universitair Ziekenhuis Gent
Gynaeoclogie-Verloskunde, Corneel Heymanslaan 10, 9000, Gent
Az St-Jan Brugge-Oostende A.V.
Gynaecologie-Verloskunde, Ruddershove 10, 8000, Brugge
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2024-06-19 | 2024-07-04 | 2025-08-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 32 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | ASQ-3 12 Mo Set A | 1 |
| Protocol (for publication) | ASQ-3 24 Mo Set A | 1 |
| Protocol (for publication) | ASQ-3 60 Mo Set A | 1 |
| Protocol (for publication) | PARCA-R | 1 |
| Protocol (for publication) | Protocol | 5 |
| Protocol (for publication) | Protocol CMV_v5_TC | 5 |
| Protocol (for publication) | Protocol Version 1 | 1 |
| Protocol (for publication) | Protocol Version 2 Track changed | 2 |
| Protocol (for publication) | Standard operating procedures | 2 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure | 1 |
| Recruitment arrangements (for publication) | Manier van rekruteren | 1 |
| Recruitment arrangements (for publication) | Old recruitement material Algemene flyer | 1 |
| Recruitment arrangements (for publication) | Old recruitement material Mijn TreatCMV boekje | 1 |
| Recruitment arrangements (for publication) | Old recruitement material Patientenfolder | 1 |
| Recruitment arrangements (for publication) | Old recruitement material Poster 1 | 1 |
| Recruitment arrangements (for publication) | recruitement material Algemene flyer | 2 |
| Recruitment arrangements (for publication) | recruitement material Artsenfolder | 1 |
| Recruitment arrangements (for publication) | recruitement material Link website | 1 |
| Recruitment arrangements (for publication) | recruitement material Mijn TreatCMV boekje | 2 |
| Recruitment arrangements (for publication) | recruitement material Patientenfolder | 2 |
| Recruitment arrangements (for publication) | recruitement material Poster 1 | 2 |
| Recruitment arrangements (for publication) | recruitement material Poster 2 | 1 |
| Recruitment arrangements (for publication) | recruitement material Storyboard | 1 |
| Subject information and informed consent form (for publication) | ICF _v2_ENG | 3 |
| Subject information and informed consent form (for publication) | ICF_v2_FR | 3 |
| Subject information and informed consent form (for publication) | Informed consent corrected clean | 3 |
| Subject information and informed consent form (for publication) | Informed consent corrected track changes | 2 |
| Subject information and informed consent form (for publication) | Informed consent information first page | 3 |
| Subject information and informed consent form (for publication) | Informed consent information first page _ EN | 3 |
| Subject information and informed consent form (for publication) | Informed consent information premiere page _ FR | 3 |
| Subject information and informed consent form (for publication) | Old Informed consent | 1 |
| Synopsis of the protocol (for publication) | Protocol Synopsis | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-05 | Belgium | Acceptable with conditions 2023-08-11
|
2023-08-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-19 | Belgium | Acceptable with conditions 2023-08-11
|
2024-07-19 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-22 | Belgium | Acceptable with conditions 2023-08-11
|
2024-08-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-28 | Belgium | Acceptable 2025-03-11
|
2025-03-13 |