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

Congenital Cytomegalovirus Infection Clinical Trial

— PreCyssion  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05170269
• Other study ID #: 997
• Secondary ID: 2020-002383-32
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 17, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2023
• Source: Biotest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: August 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Congenital Cytomegalovirus Infection
• Cytomegalovirus Infections
• Infections

Intervention

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

Locations

Country	Name	City	State
Germany	4906	Berlin
Germany	4903	Bonn
Germany	4902	Erlangen
Germany	4901	Tuebingen
Germany	4905	Wasserburg am Inn

Sponsors (1)

Lead Sponsor	Collaborator
Biotest

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Subgroups: (1) Subjects with periconceptionally acquired infection or (2) Subjects with infection acquired during first trimester	To determine the rate of maternal-fetal transmission at the time of amniocentesis	Gestational week 20 +-1 Week
Secondary	To determine maternal CMV viral load (copies/ml)	Number of CMV-DNA copies (copies/mL) and corresponding absolute and percentage changes from baseline, until gestational week (GW) 30	until gestational week 30
Secondary	To determine maternal anti-CMV IgG Levels (U/ml)	Maternal anti-CMV IgG Levels (U/ml), absolute and percentage changes from baseline	until gestational week 30
Secondary	To determine maternal anti-CMV IgG avidity (%)	Number/percentage of subjects with Low, Intermediate, High avidity	until gestational week 30
Secondary	To determine maternal anti-CMV IgM index (Index)	Number/percentage of subjects with non-reactive, indeterminate and reactive cut-off index (COI)	until gestational week 30
Secondary	To determine soluble fms-like tyrosine kinase 1 (sFlt-1) concentration in maternal serum	Number/percentage of subjects with high (=1504 pg/mL) or low (<1504 pg/mL) values	until gestational week 30
Secondary	To evaluate vitality of the fetuses/newborns	Number/percentage of subjects with Normal / Abnormal Not Clinically Significant / Abnormal Clinically Significant results per parameter and visit	until date of delivery
Secondary	To evaluate growth of the fetuses/newborns	Number/percentage of subjects with Normal / Abnormal Not Clinically Significant / Abnormal Clinically Significant results per parameter and visit	Until date of delivery
Secondary	To evaluate the rate of congenital CMV infection at delivery or within the first 3 days after delivery	To evaluate the rate of congenital CMV infection at delivery or within the first 3 days after delivery	Date of Delivery + 3 days
Secondary	To measure the number of CMV-DNA copies in the urine of newborns	To measure the number of CMV-DNA copies in the urine of newborns	Date of Delivery
Secondary	To assess the number, severity, causality, outcome, and seriousness of all adverse events (AEs)/ treatment-emergent AEs (TEAEs)/ AEs of special interest until delivery (+3 days) in both mother and fetus/newborn	To assess the number, severity, causality, outcome, and seriousness of all adverse events (AEs)/ treatment-emergent AEs (TEAEs)/ AEs of special interest until delivery (+3 days) in both mother and fetus/newborn	Date of Delivery + 3 days