Trials / Terminated
TerminatedNCT05170269
Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)
Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection With Gestational Age ≤ 14 Weeks - an Open-label, Single-arm, Prospective Trial Investigating Efficacy and Safety of Cytotect CP Biotest
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Biotest · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
A phase 3, open-label, single-arm, prospective, multi-center trial of Cytotect CP Biotest (BT097) for prevention of maternal-fetal CMV transmission after primary maternal CMV infection. The main purpose of the trial is to demonstrate efficacy and safety of Cytotect CP Biotest in preventing maternal-fetal transmission of cytomegalovirus (CMV).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BT097 | Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17 |
Timeline
- Start date
- 2021-11-17
- Primary completion
- 2023-11-19
- Completion
- 2024-03-29
- First posted
- 2021-12-27
- Last updated
- 2025-03-10
Locations
5 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT05170269. Inclusion in this directory is not an endorsement.