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Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS5798 | Registry Identifier | EU PAS Register |
Not provided
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| Name | Class |
|---|---|
| Baxalta Innovations GmbH, now part of Shire | INDUSTRY |
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The purpose of this registry is to acquire safety data (including assessment of anti-rHuPH20 antibodies), regarding the course and outcome of pregnancy in women ever treated with HYQVIA. Development of the fetus/infant at birth and for the first 2 years will also be followed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternative Product Arm | Participant stops HYQVIA treatment (if the participant is still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment will be administered, as determined by the physician. |
| |
| HYQVIA Arm | Participant continues to receive HYQVIA (Immune Globulin (Human) 10% with recombinant human hyaluronidase (rHuPH20)), according to her treatment regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment | Biological | To be determined by the physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | An Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily had a causal relationship with the treatment. A SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, is an important medical event. Number of participants with SAEs in expectant mothers and infants were reported. | From start of study drug administration up to end of study (up to 48.4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-serious Adverse Events (Non-SAEs), Related and Not Related to HyQvia/Human Normal Immunoglobulin (IG) or Alternative Treatment | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with the treatment. Number of participants with Non-SAEs, related and not related to HyQvia/Human Normal IG or alternative treatment in expectant mothers and infants were reported. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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Women who became pregnant after ever treated with HYQVIA, and their infant children
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| Name | Affiliation | Role |
|---|---|---|
| Shire Director | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QuintilesIMS Plaza Building | Durham | North Carolina | 27703 | United States | ||
| Fakultni nemocnice Kralovske Vinohrady |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35443783 | Derived | Borte M, Raffac S, Hrubisko M, Jahnz-Rozyk K, Garcia E, McCoy B, Chavan S, Nagy A, Yel L. Long-term safety of facilitated subcutaneous immunoglobulin treatment in pregnant women with primary immunodeficiency diseases: results from a registry study. Immunotherapy. 2022 Jun;14(8):609-616. doi: 10.2217/imt-2021-0336. Epub 2022 Apr 20. |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Not provided
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Total 16 participants (9 mothers and 7 infants) were enrolled in the study. Of 9 mothers, 7 included in Retrospective (R) cohort and 2 in Prospective (P) cohort. Of 7 infants enrolled from 9 mothers (1 mother lost to follow-up; another mother withdrew consent prior to delivery) of R cohort; 5 included in R cohort and 2 included in P cohort. Study consisted of Study Arm1 (Alternative Product Arm) and Study Arm2 (HyQvia Arm). All participants were analyzed according to type of enrollment R and P.
This study was conducted at 8 centers in Czech Republic, Germany, Poland, Slovakia, and United States of America from 04 December 2015 (first participant first visit) to 17 December 2019 (last participant last visit).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Retrospective Cohort: Expectant Mothers | Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 22, 2015 | Dec 16, 2020 |
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Not provided
Not provided
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Blood samples (plasma) for anti-recombinant human hyaluronidase (rHuPH20) antibodies that remain after study testing is done may be stored and used for additional testing (eg, further evaluation of an abnormal test or an adverse event). Samples will be stored in a coded form for a maximum of 2 years after the final study report has been completed and, subsequently, will be destroyed.
| HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] | Biological | Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase |
|
|
| From start of study drug administration up to end of study (up to 48.4 months) |
| Number of Participants With Adverse Event of Special Interests (AESIs) in Expectant Mothers | AESI were AEs that were considered by the sponsor to be relevant for the monitoring of the safety profile. AESI's included in this study were local/immunologic AEs including skin changes (Such as, local erythema, local pruritus, induration, nodules). Number of participants with AESIs in expectant mother were reported. | From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months) |
| Number of Participants Who Developed Anti-rHuPH20 Antibodies in Expectant Mothers | Number of participants who developed positive [titer ≥160] of anti-rHuPH20 binding in expectant mothers were reported. Neutralizing antibodies were assessed if the binding antibody assay has a result of 160 or above. | From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months) |
| Number of Participants With Antenatal Diagnostic Procedures | Antenatal diagnostic procedures included ultrasound, serology and nuchal translucency screen which are used to assess the Fetal growth/development. Number of participants reported fetal growth/development were recorded. | Throughout the expectant mother pregnancy duration (up to 40 weeks) |
| Number of Participants Who Experienced General Pregnancy Outcomes | Pregnancy outcomes included live birth, fetal death, termination or unknown. | Throughout the expectant mother pregnancy duration (up to 40 weeks) |
| Number of Participants With Neonatal Assessment | Neonatal assessment included parameters like weight, length, head circumference, Apgar scores, pulse rate, blood pressure, respiratory rate, body temperature with normal, abnormal and missing status. The Apgar scores was determined by evaluating the newborn baby on five simple criteria: Appearance, Pulse, Grimace, Activity, Respiration: on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Zero is the worst possible score and 10 is the highest possible score. | At or after delivery/end of pregnancy (up to 40 weeks) |
| Number of Participants With Status of the Infant at Birth | Status of the infant at birth included the following as: Any need for resuscitation of the infant, Admission in intensive care unit, Presence of congenital malformations/anomaly, Any other conditions noted at or around birth with status yes, no and unknown. | At or after delivery/end of pregnancy (up to 40 weeks) |
| Number of Participants With Growth Measurement and Charts for the Infant | Growth measurement and charts for the infant was assessed based on following parameters: Any congenital malformations diagnosed that were not reported at birth, any conditions that were noted since birth, weight assessment, length assessment, head circumference assessment. Number of participants with growth measurement and charts for the infant at 6, 12, 18 and 24 months follow-up was reported. | At 6, 12, 18 and 24 months follow-up |
| Number of Participants With Development Milestones | Developmental milestones evaluation included rolled over, attended to and reached for objects, sat up without support, turned to locate a voice, said his/her first words, and stand without support/help. Number of participants with development milestones at 6, 12, 18 and 24 months follow-up was reported. | At 6, 12, 18 and 24 months follow-up |
| Prague |
| 10034 |
| Czechia |
| Freiburg University Hospital/ Prof. Dr. med. Bodo Grimbacher | Freiburg im Breisgau | Baden-Wurttemberg | 79108 | Germany |
| Universitaetsklinikum Wuerzburg | Würzburg | Bavaria | 97080 | Germany |
| Klinikum St. Georg GmbH | Leipzig | Saxony | 04129 | Germany |
| Wojskowy Instytut Medyczny | Warsaw | 04-141 | Poland |
| Onkologicky ustav svatej Alzbety s.r.o. | Bratislava | 81250 | Slovakia |
| RAFMED s.r.o | Košice | 04001 | Slovakia |
| FG001 | Prospective Cohort: Expectant Mothers | Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment. |
| FG002 | Retrospective Cohort: Infants | Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment. |
| FG003 | Prospective Cohort: Infants | Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Enrolled Set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Retrospective Cohort: Expectant Mothers | Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment. |
| BG001 | Prospective Cohort: Expectant Mothers | Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment. |
| BG002 | Retrospective Cohort: Infants | Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment. |
| BG003 | Prospective Cohort: Infants | Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Events (SAEs) | An Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily had a causal relationship with the treatment. A SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, is an important medical event. Number of participants with SAEs in expectant mothers and infants were reported. | Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. | Posted | Count of Participants | Participants | From start of study drug administration up to end of study (up to 48.4 months) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Non-serious Adverse Events (Non-SAEs), Related and Not Related to HyQvia/Human Normal Immunoglobulin (IG) or Alternative Treatment | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with the treatment. Number of participants with Non-SAEs, related and not related to HyQvia/Human Normal IG or alternative treatment in expectant mothers and infants were reported. | Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. | Posted | Count of Participants | Participants | From start of study drug administration up to end of study (up to 48.4 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Event of Special Interests (AESIs) in Expectant Mothers | AESI were AEs that were considered by the sponsor to be relevant for the monitoring of the safety profile. AESI's included in this study were local/immunologic AEs including skin changes (Such as, local erythema, local pruritus, induration, nodules). Number of participants with AESIs in expectant mother were reported. | Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for infant group. | Posted | Count of Participants | Participants | From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Developed Anti-rHuPH20 Antibodies in Expectant Mothers | Number of participants who developed positive [titer ≥160] of anti-rHuPH20 binding in expectant mothers were reported. Neutralizing antibodies were assessed if the binding antibody assay has a result of 160 or above. | Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for infant group. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Antenatal Diagnostic Procedures | Antenatal diagnostic procedures included ultrasound, serology and nuchal translucency screen which are used to assess the Fetal growth/development. Number of participants reported fetal growth/development were recorded. | Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for infant group. | Posted | Count of Participants | Participants | Throughout the expectant mother pregnancy duration (up to 40 weeks) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced General Pregnancy Outcomes | Pregnancy outcomes included live birth, fetal death, termination or unknown. | Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for infant group. | Posted | Count of Participants | Participants | Throughout the expectant mother pregnancy duration (up to 40 weeks) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Neonatal Assessment | Neonatal assessment included parameters like weight, length, head circumference, Apgar scores, pulse rate, blood pressure, respiratory rate, body temperature with normal, abnormal and missing status. The Apgar scores was determined by evaluating the newborn baby on five simple criteria: Appearance, Pulse, Grimace, Activity, Respiration: on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Zero is the worst possible score and 10 is the highest possible score. | Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for Expectant mothers. | Posted | Count of Participants | Participants | At or after delivery/end of pregnancy (up to 40 weeks) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Status of the Infant at Birth | Status of the infant at birth included the following as: Any need for resuscitation of the infant, Admission in intensive care unit, Presence of congenital malformations/anomaly, Any other conditions noted at or around birth with status yes, no and unknown. | Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for Expectant mothers. | Posted | Count of Participants | Participants | At or after delivery/end of pregnancy (up to 40 weeks) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Growth Measurement and Charts for the Infant | Growth measurement and charts for the infant was assessed based on following parameters: Any congenital malformations diagnosed that were not reported at birth, any conditions that were noted since birth, weight assessment, length assessment, head circumference assessment. Number of participants with growth measurement and charts for the infant at 6, 12, 18 and 24 months follow-up was reported. | Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for Expectant mothers. | Posted | Count of Participants | Participants | At 6, 12, 18 and 24 months follow-up |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Development Milestones | Developmental milestones evaluation included rolled over, attended to and reached for objects, sat up without support, turned to locate a voice, said his/her first words, and stand without support/help. Number of participants with development milestones at 6, 12, 18 and 24 months follow-up was reported. | Enrolled set consisted of all participants who had signed informed consent and meet all inclusion/exclusion criteria at the time of enrollment. Data for this outcome was not planned to be collected and analyzed for Expectant mothers. | Posted | Count of Participants | Participants | At 6, 12, 18 and 24 months follow-up |
|
From start of study drug administration up to end of study (up to 48.4 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Retrospective Cohort: Expectant Mothers | Participants (Expectant mothers) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment. | 0 | 7 | 0 | 7 | 2 | 7 |
| EG001 | Prospective Cohort: Expectant Mothers | Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment. | 0 | 2 | 1 | 2 | 2 | 2 |
| EG002 | Retrospective Cohort: Infants | Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment. | 0 | 5 | 1 | 5 | 4 | 5 |
| EG003 | Prospective Cohort: Infants | Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment. | 0 | 2 | 1 | 2 | 1 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cleft lip | Congenital, familial and genetic disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Talipes | Congenital, familial and genetic disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia of pregnancy | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Genital herpes simplex | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Lactose intolerance | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 19.0 | Non-systematic Assessment |
| |
| Uterine contractions during pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 2, 2020 | Dec 16, 2020 | SAP_001.pdf |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
| OG002 | Retrospective Cohort: Infants | Participants (Infants) in the study arm 1 (Alternative Product arm) who stopped HYQVIA treatment (if the participant was still treated) and a licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment were administered, as determined by the physician. Retrospective cohort included participants with condition of the fetus had been assessed through prenatal testing such as targeted ultrasound, via the antenatal diagnostic CRF, prior to the time of enrollment or the outcome of the pregnancy was known prior to the time of enrollment. |
| OG003 | Prospective Cohort: Infants | Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment. |
|
|
Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment. |
|
|
Participants (Expectant mothers) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment. |
|
|
|
|
|
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| Prospective Cohort: Infants |
Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment. |
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Participants (Infants) in the study arm 2 (HyQvia Arm) continued to receive HYQVIA (Immune Globulin [Human] 10% with recombinant human hyaluronidase [rHuPH20]), according to her treatment regimen. Prospective cohort included participants with condition of the fetus had not been assessed through prenatal testing such as targeted ultrasound prior to the time of enrollment and the outcome of the pregnancy was not known at the time of enrollment.
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