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

NCT05170269 | Terminated Phase 3 DMC

• 2 other identifiers: 9972020-002383-32
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

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

Keywords

Cytomegalovirus; Pregnancy; CMVIG; maternal CMV infection

Outcome Measures

Primary Outcomes (1)

• To determine the overall rate of maternal-fetal transmission at the time of amniocentesis (week 20 [-1 week / +2 weeks] of gestation)

  To determine the overall rate of maternal-fetal transmission at the time of amniocentesis

  Gestational week 19 - week 22

Secondary Outcomes (11)

• Subgroups: (1) Subjects with periconceptionally acquired infection or (2) Subjects with infection acquired during first trimester

  Gestational week 20 +-1 Week

• To determine maternal CMV viral load (copies/ml)

  until gestational week 30

• To determine maternal anti-CMV IgG Levels (U/ml)

  until gestational week 30

• To determine maternal anti-CMV IgG avidity (%)

  until gestational week 30

• To determine maternal anti-CMV IgM index (Index)

  until gestational week 30

Study Arms (1)

BT097

EXPERIMENTAL

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

Drug: BT097

Interventions

BT097 DRUG

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

Also known as: Cytotect CP Biotest 100 U/mL solution for infusion

BT097

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Biotest: lead

Study Sites (5)

4906

Berlin, 13353, Germany

Location

4903

Bonn, 53127, Germany

Location

4902

Erlangen, 91054, Germany

Location

4901

Tübingen, 72076, Germany

Location

4905

Wasserburg am Inn, 83512, Germany

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Solutions

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Karl O Kagan, Prof

  Universitätsklinik Tuebingen - Frauenklinik; 72076 Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: December 27, 2021
• Study Start: November 17, 2021
• Primary Completion: November 19, 2023
• Study Completion: March 29, 2024
• Last Updated: March 10, 2025

Record last verified: 2024-12

Locations

DE (5)