Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-29 @ 1:17 PM
Study NCT ID:
NCT05170269
Status:
TERMINATED
Last Update Posted:
2025-03-10
First Post:
2021-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-12-09', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the overall rate of maternal-fetal transmission at the time of amniocentesis (week 20 [-1 week / +2 weeks] of gestation)', 'timeFrame': 'Gestational week 19 - week 22', 'description': 'To determine the overall rate of maternal-fetal transmission at the time of amniocentesis'}], 'secondaryOutcomes': [{'measure': 'Subgroups: (1) Subjects with periconceptionally acquired infection or (2) Subjects with infection acquired during first trimester', 'timeFrame': 'Gestational week 20 +-1 Week', 'description': 'To determine the rate of maternal-fetal transmission at the time of amniocentesis'}, {'measure': 'To determine maternal CMV viral load (copies/ml)', 'timeFrame': 'until gestational week 30', 'description': 'Number of CMV-DNA copies (copies/mL) and corresponding absolute and percentage changes from baseline, until gestational week (GW) 30'}, {'measure': 'To determine maternal anti-CMV IgG Levels (U/ml)', 'timeFrame': 'until gestational week 30', 'description': 'Maternal anti-CMV IgG Levels (U/ml), absolute and percentage changes from baseline'}, {'measure': 'To determine maternal anti-CMV IgG avidity (%)', 'timeFrame': 'until gestational week 30', 'description': 'Number/percentage of subjects with Low, Intermediate, High avidity'}, {'measure': 'To determine maternal anti-CMV IgM index (Index)', 'timeFrame': 'until gestational week 30', 'description': 'Number/percentage of subjects with non-reactive, indeterminate and reactive cut-off index (COI)'}, {'measure': 'To determine soluble fms-like tyrosine kinase 1 (sFlt-1) concentration in maternal serum', 'timeFrame': 'until gestational week 30', 'description': 'Number/percentage of subjects with high (≥1504 pg/mL) or low (\\<1504 pg/mL) values'}, {'measure': 'To evaluate vitality of the fetuses/newborns', 'timeFrame': 'until date of delivery', 'description': 'Number/percentage of subjects with Normal / Abnormal Not Clinically Significant / Abnormal Clinically Significant results per parameter and visit'}, {'measure': 'To evaluate growth of the fetuses/newborns', 'timeFrame': 'Until date of delivery', 'description': 'Number/percentage of subjects with Normal / Abnormal Not Clinically Significant / Abnormal Clinically Significant results per parameter and visit'}, {'measure': 'To evaluate the rate of congenital CMV infection at delivery or within the first 3 days after delivery', 'timeFrame': 'Date of Delivery + 3 days', 'description': 'To evaluate the rate of congenital CMV infection at delivery or within the first 3 days after delivery'}, {'measure': 'To measure the number of CMV-DNA copies in the urine of newborns', 'timeFrame': 'Date of Delivery', 'description': 'To measure the number of CMV-DNA copies in the urine of newborns'}, {'measure': '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', 'timeFrame': 'Date of Delivery + 3 days', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cytomegalovirus', 'Pregnancy', 'CMVIG', 'maternal CMV infection'], 'conditions': ['Congenital Cytomegalovirus Infection']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Pregnant women, age 18 to 45 years\n* Pregnant women at trial entry with gestational age ≤14 weeks; pregnancy after in-vitro fertilization permitted\n* Detection of early primary CMV infection\n\nExclusion Criteria:\n\n* Women with current multiple pregnancy\n* History of severe pre-eclampsia or severe gestational hypertension (GHTN), which required medical intervention. Definition according to AWMF guideline (AWMF, 2019)\n* Presence of severe disease impairing course of pregnancy (e.g. diabetes, epilepsy, cancer)\n* Congenital or acquired autoimmune disease\n* Known immunosuppressive (e.g., transplanted patients) or immunodeficient condition\n* Known infection with hepatitis B or C, or HIV from the medical history or active infection at screening as assessed by respective virus serology\n* Maternal CMV infection prior to this pregnancy (preconceptional CMV infection)\n* Covid-19 infection at time of inclusion\n* 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\n* Active infection according to TORCH serology with exception of CMV in the assessment of the investigator\n* Known major fetal anomalies or demise\n* Intolerance to proteins of human origin or known allergic reactions to components of the trial product\n* Selective absolute IgA deficiency or known antibodies to IgA\n* Known pre-existing clinically relevant risk factors for thrombotic events\n* 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)\n* Participation in another clinical trial within 90 days before entering the trial or during the trial\n* Women who are dependent on trial site staff, on Biotest AG or its authorized representatives\n* Inability or lacking motivation to participate in the trial\n* 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\n* Eligibility for a subgroup where enrollment was stopped'}, 'identificationModule': {'nctId': 'NCT05170269', 'acronym': 'PreCyssion', 'briefTitle': 'Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotest'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '997'}, 'secondaryIdInfos': [{'id': '2020-002383-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BT097', 'description': 'Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17', 'interventionNames': ['Drug: BT097']}], 'interventions': [{'name': 'BT097', 'type': 'DRUG', 'otherNames': ['Cytotect CP Biotest 100 U/mL solution for infusion'], 'description': 'Subjects will receive BT097 200 U per kg of maternal body weight intravenously every 2 weeks until at least GW 17', 'armGroupLabels': ['BT097']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': '4906', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': '4903', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': '4902', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': '4901', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '83512', 'city': 'Wasserburg am Inn', 'country': 'Germany', 'facility': '4905', 'geoPoint': {'lat': 48.0525, 'lon': 12.22341}}], 'overallOfficials': [{'name': 'Karl O Kagan, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinik Tuebingen - Frauenklinik; 72076 Tübingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotest', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}