Cytotect CP Biotest (human cytomegalovirus immunoglobulin) / Grifols - LARVOL DELTA

ETHNIC DISPARITIES IN RESPONSE TO CMV IMMUNOTHERAPY USING INTRAVENOUS CMV HYPERIMMUNE GLOBULIN IN PEDIATRIC ALLO-HSCT RECIPIENTS (EBMT 2025) - "These results highlight the efficacy of CMV hyperimmune globulin prophylaxis and significant ethnic disparities in treatment response. Ethnicity may influence treatment outcomes, depending on the CMV-IG donor pool used. No literature compares outcomes of CMV hyperimmune globulin in European vs."

Clinical • Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Immunology • Infectious Disease • Pediatrics • CD4

ETHNIC DISPARITIES IN RESPONSE TO CMV IMMUNOTHERAPY USING INTRAVENOUS CMV HYPERIMMUNE GLOBULIN IN PEDIATRIC ALLO-HSCT RECIPIENTS (EBMT 2025) - "These results highlight the efficacy of CMV hyperimmune globulin prophylaxis and significant ethnic disparities in treatment response. Ethnicity may influence treatment outcomes, depending on the CMV-IG donor pool used. No literature compares outcomes of CMV hyperimmune globulin in European vs."

Clinical • Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Immunology • Infectious Disease • Pediatrics • CD4

Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion) (clinicaltrials.gov) - P3 | N=48 | Terminated | Sponsor: Biotest | N=80 ➔ 48 | Trial completion date: Aug 2024 ➔ Mar 2024 | Active, not recruiting ➔ Terminated; Sponsor decision

Enrollment change • Trial completion date • Trial termination • Cytomegalovirus Infection • Infectious Disease

Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion) (clinicaltrials.gov) - P3 | N=80 | Active, not recruiting | Sponsor: Biotest | Recruiting ➔ Active, not recruiting

Enrollment closed • Cytomegalovirus Infection • Infectious Disease • FLT1

Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion) (clinicaltrials.gov) - P3; N=80; Recruiting; Sponsor: Biotest

Clinical • New P3 trial • Cytomegalovirus Infection • Infectious Disease • FLT1

Biotest AG: Biotest treats first CMV-positive pregnant woman in Phase III clinical trial to prevent transmission of CMV infection to the unborn child (Yahoo News) - "Biotest today announced today that the first pregnant woman in Germany has been treated with Cytotect CP Biotest(R) for the prevention of CMV infection of her unborn child in the clinical trial PreCyssion (Prevention of maternal-foetal Cytomegalovirus transmission after primary maternal infection)....The PreCyssion trial will be conducted in Germany and enrol approximately 80 women with confirmed primary CMV infection in early pregnancy (gestational age <= 14 weeks). After confirmation of primary CMV infection, the women will be treated with 2ml of Cytotect CP Biotest(R) per kg body weight every second week until about 18 weeks' gestation. For the assessment of CMV status of the foetus (primary endpoint), each woman will undergo amniocentesis after end of treatment at about 20 weeks' gestation."

Trial status • Cytomegalovirus Infection • Infectious Disease

Biotest receives approval for phase III clinical trial in pregnant women for prevention of CMV infection of the unborn baby (Biotest Press Release) - "Recently published results of an observational study show a CMV transmission rate of 6.5%, which is much lower compared to historical data of 35.2%....Biotest today announced that their application to conduct the clinical trial PreCyssion (Prevention of maternal-foetal Cytomegalovirus transmission after primary maternal infection) was approved by the Competent Authority and the responsible Ethics Committee in Germany....This open-label, single-arm, prospective phase III clinical trial is investigating the efficacy and safety of Biotest's CMV hyperimmunoglobulin (CMVIG) Cytotect CP Biotest(R) for treatment of CMV infected pregnant women to prevent CMV transmission to the foetus. The trial will be conducted in Germany and enrol approximately 80 women with confirmed primary CMV infection in early pregnancy (gestational age <= 14 weeks)."

New P3 trial • Observational data • Cytomegalovirus Infection • Infectious Disease