Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
200
Countries
1
Sites
2
primary cytomegalovirus (CMV) infection
The aim of the study is to compare the efficacy and safety of valacyclovir in the prevention of transmission and treatment of intrauterine infection in pregnant women with primary CMV infection in a dose-dependent manner.
Key facts
- Sponsor
- Instytut Matki I Dziecka
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 2 Aug 2024 → ongoing
- Decision date (initial)
- 2024-02-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Agencja Badań Medycznych
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Prophylaxis, Therapy, Safety
The aim of the study is to compare the efficacy and safety of valacyclovir in the prevention of transmission and treatment of intrauterine infection in pregnant women with primary CMV infection in a dose-dependent manner.
Secondary objectives 3
- Comparison of the efficacy of valacyclovir in the prevention of transmission and treatment of intrauterine infection in pregnant women with primary cytomegalovirus infection according to the drug dose used.
- Safety evaluation of valacyclovir depending on the drug dose used.
- Evaluation of patients' adherence to therapeutic recommendations depending on the drug dose used.
Conditions and MedDRA coding
primary cytomegalovirus (CMV) infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10009703 | CMV infection | 10021881 |
Study design 5 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Prescreening przed 10 (±6) tygodniem ciąży (pacjentki bez potwierdzenia aktywnej infekcji CMV) Pacjentka podpisuje Formularz Świadomej Zgody na udział w prescreeningu. Faza prescreeningu dla 4000 Pacjentek obejmie diagnostykę CMV: przeciwciała przeciwko CMV w klasach IgM i IgG oraz awidność przeciwciał IgG Dopiero po potwierdzeniu cech aktywnego zakażenia, możliwy jest udział w Badaniu Klinicznym.
|
Not Applicable | None | ||
| 2 | Wizyta 1 przesiewowa w 10 (±6) tygodniu ciąży (dotyczy wszystkich pacjentek) Wszystkie zaplanowane niniejszym Protokołem badania kwalifikacyjne muszą zostać zakończone i poddane weryfikacji w celu potwierdzenia, że Pacjentki spełniają wszystkie kryteria włączenia przed podaniem pierwszej dawki BPL. Badacz zbiera podstawowe dane demograficzne i kliniczne Pacjentki. Badacz przeprowadza badanie fizykalne, wykonuje pomiar parametrów życiowych oraz zleca Pacjentce badania laboratoryjne oraz USG ciążowe.
|
Not Applicable | None | ||
| 3 | Randomizacja, okres leczenia i wizyty kontrolne Pacjentki ciężarne z pierwotną infekcją wirusem cytomegalii, spełniające kryteria włączenia do Badania i niespełniający kryteriów wyłączenia będą randomizowane ze stratyfikacją ze względu na przypuszczalny moment, w którym doszło do zakażenia (okołokoncepcyjnie czy w I trymestrze) szacowanego na podstawie wartości awidności przeciwciał przeciwko CMV w klasie IgG.
|
Randomised Controlled | None | Grupa 1: Pacjentki otrzymujące walacyklowir w dawce 4g/dobę przez okres maksymalnie 16 tygodni. Grupa 2: Pacjentki otrzymujące walacyklowir w dawce 8g/dobę przez okres maksymalnie 16 tygodni. |
|
| 4 | Follow-up po zakończeniu leczenia Odbędą się 3 wizyty follow-up, w ramach których oceniony zostanie stan zdrowia Uczestniczki i płodu. Badacz zbierze wywiad medyczny, dokona pomiarów parametrów życiowych, wykona USG ciąży i rezonans magnetyczny płodu oraz przeprowadzi z Uczestniczką wywiad w kierunku możliwych zdarzeń niepożądanych.
|
Not Applicable | None | ||
| 5 | Badanie noworodka po porodzie i ocena stanu Pacjentki W okresie pierwszych 21 dni po porodzie, noworodkom zostaną wykonane badania masy urodzeniowej, długości ciała, obwodu głowy, badania laboratoryjne, badanie molekularne, badanie audiologiczne oraz badanie obrazowe: USG jamy brzusznej, USG przezciemiączkowe. Powyższa diagnostyka ma na celu identyfikację skutków transmisji zakażenia CMV od matki do płodu.
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Pregnant women aged 18 years and older.
- The presence of IgG antibodies to CMV, whose previous result in the current pregnancy was negative (seroconversion) and/or antibodies to CMV in the IgM and IgG classes with low avidity (below 50% or index marked by the laboratory as low avidity)
- The presence of the above-mentioned antibodies before 16 weeks of pregnancy.
- Giving written informed consent to participate in the study.
- Confirmed singleton or twin pregnancy.
Exclusion criteria 9
- Pregnant women aged under 18.
- Known allergy or hypersensitivity to valacyclovir or acyclovir.
- Mental disorder or intellectual disability.
- Renal disease, abnormal liver function parameters, chronic diseases.
- A patient who participated in any other clinical trial 3 months before enrollment in the study.
- Positive result of screening tests for viral diseases performed routinely in accordance with the standard of perinatal care (HBV, HIV, HCV), active/recent TOXO infection, WR.
- Patients not vaccinated against tuberculosis.
- Contraindications to magnetic resonance imaging.
- Multiple pregnancy (more than twins).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of newborns in whom CMV DNA was not detected in the amniotic fluid in the compared groups (assessed at visits 4 and 5).
Secondary endpoints 5
- CMV DNA replication level in fetal blood according to CMV DNA replication level in maternal blood (assessed at visit 5).
- Platelet count in the fetus depending on the dose of drug used (assessed at visit 5)
- Percentage of missed doses of a drug in the compared groups (assessed by interview at each visit, from 1 to 5).
- The percentage of newborns in whom the presence of CMV DNA in the amniotic fluid was not detected in the compared groups depending on the level of virus replication in the amniotic fluid (assessed on visits 4 and 5).
- Assessment of the frequency of adverse events in the study groups.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB00003MIG · Substance
- Active substance
- Valaciclovir
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 8 g gram(s)
- Max total dose
- 896 g gram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Instytut Matki I Dziecka
- Sponsor organisation
- Instytut Matki I Dziecka
- Address
- Ul Marcina Kasprzaka 17 A
- City
- Warsaw
- Postcode
- 01-211
- Country
- Poland
Scientific contact point
- Organisation
- Instytut Matki I Dziecka
- Contact name
- Klinika Położnictwa
Public contact point
- Organisation
- Instytut Matki I Dziecka
- Contact name
- Klinika Położnictwa
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Cefea Sp. z o.o. S.K. ORG-100015378
|
Warsaw, Poland | Code 14 |
| Medicofarma S.A. ORG-100001605
|
Radom, Poland | Code 14 |
| Masha Regulatory Service Anna Jelitto ORL-000003460
|
Warsaw, Poland | On site monitoring, Code 11, Code 12, Code 5, Code 8 |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 200 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Poland | 2024-08-02 | 2024-08-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-508643-46-00 | 5.0 |
| Protocol (for publication) | D1_Protocol signature page 2023-508643-46-00_redacted | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_poster | 1 |
| Subject information and informed consent form - Extract (for publication) | L1_SIS and ICF_tracked changes | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 5.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Attachment | 2.0 |
| Subject information and informed consent form (for publication) | L3_GP Letter | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vaciclor | 30 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PL 2023-508643-46-00 | 2.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-27 | Poland | Acceptable with conditions 2024-02-19
|
2024-02-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-13 | Poland | Acceptable 2024-07-29
|
2024-08-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-02 | Poland | Acceptable 2025-07-28
|
2025-08-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-01 | Poland | Acceptable 2026-03-07
|
2026-03-10 |