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Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)

NCT05170269 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-03-10

No results posted yet for this study

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

  • Congenital Cytomegalovirus Infection

Interventions

DRUG

BT097

Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17

Sponsors & Collaborators

  • Biotest

    lead INDUSTRY

Principal Investigators

  • Karl O Kagan, Prof · Universitätsklinik Tuebingen - Frauenklinik; 72076 Tübingen

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2023-11-19
Completion
2024-03-29

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05170269 on ClinicalTrials.gov