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

B

Biotest

Status and phase

Active, not recruiting
Phase 3

Conditions

Congenital Cytomegalovirus Infection

Treatments

Drug: BT097

Study type

Interventional

Funder types

Industry

Identifiers

NCT05170269
2020-002383-32 (EudraCT Number)
997

Details and patient eligibility

About

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).

Enrollment

80 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No 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
  • Eligibility for a subgroup where enrollment was stopped

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

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

Trial contacts and locations

5

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Central trial contact

Andrea Wartenberg-Demand, Dr. med.

Data sourced from clinicaltrials.gov

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