Congenital Cytomegalovirus InfectionPhase 3PreCyssionNCT05170269
Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)
A Phase 3 study testing BT097 in people with Congenital Cytomegalovirus Infection, run by Biotest at 5 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Congenital Cytomegalovirus Infection
- What is being tested?
- BT097
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesGermany
- Study dates
- 17 Nov 2021to 29 Mar 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
4906
Berlin, 13353
4903
Bonn, 53127
4902
Erlangen, 91054
4901
Tübingen, 72076
4905
Wasserburg am Inn, 83512
About this study
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
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
- Being tested
- BT097
- Keywords
- Cytomegalovirus, Pregnancy, CMVIG, maternal CMV infection
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT097Drug
Also called Cytotect CP Biotest 100 U/mL solution for infusion
Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17
| Study group | Role | What they receive |
|---|---|---|
| BT097 | Experimental | Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17 Receives: Drug: BT097 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Gestational week 19 - week 22
Secondary outcomes (11)
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
Measured: Gestational week 20 +-1 Week
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
Measured: until gestational week 30
To determine maternal anti-CMV IgG Levels (U/ml)
Maternal anti-CMV IgG Levels (U/ml), absolute and percentage changes from baseline
Measured: until gestational week 30
To determine maternal anti-CMV IgG avidity (%)
Number/percentage of subjects with Low, Intermediate, High avidity
Measured: until gestational week 30
To determine maternal anti-CMV IgM index (Index)
Number/percentage of subjects with non-reactive, indeterminate and reactive cut-off index (COI)
Measured: until gestational week 30
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
Measured: until gestational week 30
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
Measured: until date of delivery
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
Measured: Until date of delivery
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
Measured: Date of Delivery + 3 days
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
Measured: Date of Delivery
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
Measured: Date of Delivery + 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start17 Nov 2021
- Primary completion19 Nov 2023
- Study completion29 Mar 2024
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Cytomegalovirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotest
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl O Kagan, Prof, Principal investigator, Universitätsklinik Tuebingen - Frauenklinik; 72076 Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170269
- Sponsor's protocol ID
- 997
- Other IDs
- 2020-002383-32
- Acronym
- PreCyssion
- Status last verified
- Dec 2024
- First submitted
- 19 Oct 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05170269
- Acronym / sponsor ID
- PreCyssion / 997
- Conditions
- Congenital Cytomegalovirus Infection
- Keywords
- Cytomegalovirus, Pregnancy, CMVIG, maternal CMV infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 48 participants (actual)
- Lead sponsor
- BiotestIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 19 Nov 2023 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BT097 | Experimental | Drug: BT097Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BT097Also: Cytotect CP Biotest 100 U/mL solution for infusionSubjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17 | Drug | BT097 |
Primary outcome
To determine the overall rate of maternal-fetal transmission at the time of amniocentesis (week 20 [-1 week / +2 weeks] of gestation)
Time frame: Gestational week 19 - week 22
To determine the overall rate of maternal-fetal transmission at the time of amniocentesis
11 secondary outcomes
Subgroups: (1) Subjects with periconceptionally acquired infection or (2) Subjects with infection acquired during first trimester
Time frame: Gestational week 20 +-1 Week
To determine maternal CMV viral load (copies/ml)
Time frame: until gestational week 30
To determine maternal anti-CMV IgG Levels (U/ml)
Time frame: until gestational week 30
To determine maternal anti-CMV IgG avidity (%)
Time frame: until gestational week 30
To determine maternal anti-CMV IgM index (Index)
Time frame: until gestational week 30
To determine soluble fms-like tyrosine kinase 1 (sFlt-1) concentration in maternal serum
Time frame: until gestational week 30
To evaluate vitality of the fetuses/newborns
Time frame: until date of delivery
To evaluate growth of the fetuses/newborns
Time frame: Until date of delivery
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
To measure the number of CMV-DNA copies in the urine of newborns
Time frame: Date of Delivery
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
Time frame: Date of Delivery + 3 days
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl O Kagan, Prof principal investigator
Universitätsklinik Tuebingen - Frauenklinik; 72076 Tübingen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BT097 in people with Congenital Cytomegalovirus Infection, run by Biotest at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the overall rate of maternal-fetal transmission at the time of amniocentesis (week 20 [-1 week / +2 weeks] of gestation) (time frame: Gestational week 19 - week 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.