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

NCT ID: NCT05170269

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-17
• Study Completion Date: 2024-03-29

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BT097

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

Group Type: EXPERIMENTAL

BT097

Intervention Type: DRUG

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

Interventions

BT097

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

Intervention Type: DRUG

Other Intervention Names

Cytotect CP Biotest 100 U/mL solution for infusion

Eligibility Criteria

Inclusion Criteria

• Written informed consent obtained from subjects indicating that they understand the purpose of and procedures required for the trial and are willing to participate in it
• Pregnant women, age 18 to 45 years
• Pregnant women at trial entry with gestational age ≤14 weeks; pregnancy after in-vitro fertilization permitted
• Detection of early primary CMV infection

Exclusion Criteria

• Women with current multiple pregnancy
• History of severe pre-eclampsia or severe gestational hypertension (GHTN), which required medical intervention. Definition according to AWMF guideline (AWMF, 2019)
• Presence of severe disease impairing course of pregnancy (e.g. diabetes, epilepsy, cancer)
• Congenital or acquired autoimmune disease
• Known immunosuppressive (e.g., transplanted patients) or immunodeficient condition
• Known infection with hepatitis B or C, or HIV from the medical history or active infection at screening as assessed by respective virus serology
• Maternal CMV infection prior to this pregnancy (preconceptional CMV infection)
• Covid-19 infection at time of inclusion
• Any signs or symptoms indicating an increased risk of abortion or premature labor or has known negative effect on fetus with exception of a CMV infection
• Active infection according to TORCH serology with exception of CMV in the assessment of the investigator
• Known major fetal anomalies or demise
• Intolerance to proteins of human origin or known allergic reactions to components of the trial product
• Selective absolute IgA deficiency or known antibodies to IgA
• Known pre-existing clinically relevant risk factors for thrombotic events
• Known renal insufficiency with serum creatinine levels >1.4 mg/dL and proteinuria (albuminuria) at screening (≥30 mg/dL or dipstick reading of 1+ and greater)
• Participation in another clinical trial within 90 days before entering the trial or during the trial
• Women who are dependent on trial site staff, on Biotest AG or its authorized representatives
• Inability or lacking motivation to participate in the trial
• Medical condition, laboratory finding, or physical examination finding that in the opinion of the investigator precludes participationInability or lacking motivation to participate in the trial
• Eligibility for a subgroup where enrollment was stopped

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biotest

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl O Kagan, Prof

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik Tuebingen - Frauenklinik; 72076 Tübingen

Locations

4906

Berlin, , Germany

4903

Bonn, , Germany

4902

Erlangen, , Germany

4901

Tübingen, , Germany

4905

Wasserburg am Inn, , Germany

Countries

Germany

Other Identifiers

2020-002383-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

997

Identifier Type: -

Identifier Source: org_study_id