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

Primary Purpose

Congenital Cytomegalovirus Infection

Status

Active

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

BT097

About this trial

This is an interventional prevention trial for Congenital Cytomegalovirus Infection focused on measuring Cytomegalovirus, Pregnancy, CMVIG, maternal CMV infection

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

4906
4903
4902
4901
4905

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BT097

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Maternal anti-CMV IgG Levels (U/ml), absolute and percentage changes from baseline

To determine maternal anti-CMV IgG avidity (%)

Number/percentage of subjects with Low, Intermediate, High avidity

To determine maternal anti-CMV IgM index (Index)

Number/percentage of subjects with non-reactive, indeterminate and reactive cut-off index (COI)

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

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

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

To evaluate the rate of congenital CMV infection at delivery or within the first 3 days after delivery

To measure the number of CMV-DNA copies in the urine of newborns

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

Full Information

NCT ID

NCT05170269

First Posted

October 19, 2021

Last Updated

October 19, 2023

Sponsor

Biotest

1. Study Identification

Unique Protocol Identification Number

NCT05170269

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 17, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biotest

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Cytomegalovirus Infection

Keywords

Cytomegalovirus, Pregnancy, CMVIG, maternal CMV infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BT097

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BT097

Other Intervention Name(s)

Cytotect CP Biotest 100 U/mL solution for infusion

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Gestational week 19 - week 22

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Gestational week 20 +-1 Week

Title

To determine maternal CMV viral load (copies/ml)

Description

Number of CMV-DNA copies (copies/mL) and corresponding absolute and percentage changes from baseline, until gestational week (GW) 30

Time Frame

until gestational week 30

Title

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

Description

Maternal anti-CMV IgG Levels (U/ml), absolute and percentage changes from baseline

Time Frame

until gestational week 30

Title

To determine maternal anti-CMV IgG avidity (%)

Description

Number/percentage of subjects with Low, Intermediate, High avidity

Time Frame

until gestational week 30

Title

To determine maternal anti-CMV IgM index (Index)

Description

Number/percentage of subjects with non-reactive, indeterminate and reactive cut-off index (COI)

Time Frame

until gestational week 30

Title

To determine soluble fms-like tyrosine kinase 1 (sFlt-1) concentration in maternal serum

Description

Number/percentage of subjects with high (≥1504 pg/mL) or low (<1504 pg/mL) values

Time Frame

until gestational week 30

Title

To evaluate vitality of the fetuses/newborns

Description

Number/percentage of subjects with Normal / Abnormal Not Clinically Significant / Abnormal Clinically Significant results per parameter and visit

Time Frame

until date of delivery

Title

To evaluate growth of the fetuses/newborns

Description

Number/percentage of subjects with Normal / Abnormal Not Clinically Significant / Abnormal Clinically Significant results per parameter and visit

Time Frame

Until date of delivery

Title

To evaluate the rate of congenital CMV infection at delivery or within the first 3 days after delivery

Description

To evaluate the rate of congenital CMV infection at delivery or within the first 3 days after delivery

Time Frame

Date of Delivery + 3 days

Title

To measure the number of CMV-DNA copies in the urine of newborns

Description

To measure the number of CMV-DNA copies in the urine of newborns

Time Frame

Date of Delivery

Title

Description

Time Frame

Date of Delivery + 3 days

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Pregnant women

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karl O Kagan, Prof

Organizational Affiliation

Universitätsklinik Tuebingen - Frauenklinik; 72076 Tübingen

Official's Role

Principal Investigator

Facility Information:

Facility Name

4906

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

4903

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

4902

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

4901

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

4905

City

Wasserburg am Inn

ZIP/Postal Code

83512

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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