NCT05803200

Brief Summary

The main aim of this study is to provide further information on the safety profile of HyQvia during pregnancy. This will be done by checking the characteristics of the mother and their babies. They will also be checked for any safety outcomes that will occur when exposed to HyQvia during pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

March 14, 2023

Last Update Submit

September 22, 2023

Conditions

Exposure During Pregnancy

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (7)

  • Number of Participants with Major Congenital Malformations in the Infant

    A major malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Data for infants will be reviewed in the database from the date of delivery to 90 days following birth to check for any malformations. The number of infants with malformations during the database period of 1 January 2014 to 31 December 2020 (up to 7 years) will be reported.

    Up to 7 years

  • Number of Participants with Spontaneous Abortion

    Spontaneous abortion is defined as pregnancy loss before 20 weeks of gestation.

    Up to 7 years

  • Number of Participants with Stillbirth

    Stillbirth is defined as a fetal death after 20 weeks of gestation.

    Up to 7 years

  • Number of Participants with Preterm Birth

    Pre-term birth is defined as delivery before 37 weeks of gestation.

    Up to 7 years

  • Number of Participants Being Small for Gestational Age (SGA)

    SGA will be defined as weight at birth of full and preterm live-born infants in \<10th percentile.

    Up to 7 years

  • Number of Participants with Admission to Neonatal Intensive Care Unit (NICU)

    NICU admissions will be identified by current procedure terminology (CPT) codes in maternal and infant claims within 30 days of delivery.

    Up to 7 years

  • Number of Participants With Any Major Clinical Diagnosis or Procedures

    Major clinical diagnoses include preeclampsia, post-partum hemorrhage, infections and thrombosis while procedures include cesarean section.

    Up to 7 years

Study Arms (1)

HyQvia

Pregnant female participants who have insurance coverage with full prescriptions benefits exposed to HyQvia during the period from 90 days before the last menstrual period (LMP) through 30 days after delivery will be observed retrospectively from 1 January 2014 to 31 December 2020 (up to 7 years).

Drug: No intervention

Interventions

No interventionDRUG

No intervention was given as this is an observational study.

HyQvia

Eligibility Criteria

Age16 Years - 44 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females who were exposed to HyQVia during pregnancy would be enrolled in the study.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Commercially insured US pregnant women exposed to HyQvia from 90 days before LMP to the end of pregnancy and their infants included in the MarketScan Research Database during the period 2014-2020.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Links

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

April 7, 2023

Study Start

March 15, 2023

Primary Completion

April 14, 2023

Study Completion

April 14, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, CSR
Access Criteria
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.
More information

Locations

US(1)