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Trial record 1 of 1 for:    2020-002383-32
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Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion) (PreCyssion)

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ClinicalTrials.gov Identifier: NCT05170269
Recruitment Status : Recruiting
First Posted : December 27, 2021
Last Update Posted : August 18, 2022
Sponsor:
Information provided by (Responsible Party):
Biotest

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).

Condition or disease Intervention/treatment Phase
Congenital Cytomegalovirus Infection Drug: BT097 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : November 17, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : August 31, 2024


Arm Intervention/treatment
Experimental: BT097
Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17
Drug: BT097
Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17
Other Name: Cytotect CP Biotest 100 U/mL solution for infusion




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 the rate of maternal-fetal transmission at the time of amniocentesis

  2. To determine maternal CMV viral load (copies/ml) [ Time Frame: until gestational week 30 ]
    Number of CMV-DNA copies (copies/mL) and corresponding absolute and percentage changes from baseline, until gestational week (GW) 30

  3. To determine maternal anti-CMV IgG Levels (U/ml) [ Time Frame: until gestational week 30 ]
    Maternal anti-CMV IgG Levels (U/ml), absolute and percentage changes from baseline

  4. To determine maternal anti-CMV IgG avidity (%) [ Time Frame: until gestational week 30 ]
    Number/percentage of subjects with Low, Intermediate, High avidity

  5. To determine maternal anti-CMV IgM index (Index) [ Time Frame: until gestational week 30 ]
    Number/percentage of subjects with non-reactive, indeterminate and reactive cut-off index (COI)

  6. To determine soluble fms-like tyrosine kinase 1 (sFlt-1) concentration in maternal serum [ Time Frame: until gestational week 30 ]
    Number/percentage of subjects with high (≥1504 pg/mL) or low (<1504 pg/mL) values

  7. To evaluate vitality of the fetuses/newborns [ Time Frame: until date of delivery ]
    Number/percentage of subjects with Normal / Abnormal Not Clinically Significant / Abnormal Clinically Significant results per parameter and visit

  8. To evaluate growth of the fetuses/newborns [ Time Frame: Until date of delivery ]
    Number/percentage of subjects with Normal / Abnormal Not Clinically Significant / Abnormal Clinically Significant results per parameter and visit

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

  10. To measure the number of CMV-DNA copies in the urine of newborns [ Time Frame: Date of Delivery ]
    To measure the number of CMV-DNA copies in the urine of newborns

  11. 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 ]
    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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05170269


Contacts
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Contact: Andrea Wartenberg-Demand, Dr. med. +49 6103 801 ext 0 andrea.wartenberg-demand@biotest.com

Locations
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Germany
4903 Recruiting
Bonn, Germany, 53127
Contact: Annegret Geipel, Prof Dr. med         
4902 Recruiting
Erlangen, Germany, 91054
Contact: Michael Schneider, Dr. med         
4901 Recruiting
Tuebingen, Germany, 72076
Contact: Karl O. Kagan, Prof. Dr. med         
4905 Recruiting
Wasserburg am Inn, Germany, 83512
Contact: Julia Jückstock, PD Dr. med         
Sponsors and Collaborators
Biotest
Investigators
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Principal Investigator: Karl O Kagan, Prof Universitätsklinik Tuebingen - Frauenklinik; 72076 Tübingen
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Responsible Party: Biotest
ClinicalTrials.gov Identifier: NCT05170269    
Other Study ID Numbers: 997
2020-002383-32 ( EudraCT Number )
First Posted: December 27, 2021    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biotest:
Cytomegalovirus
Pregnancy
CMVIG
maternal CMV infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Cytomegalovirus Infections
Disease Attributes
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections
Virus Diseases