Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)

Completed

• Conditions: Primary Immunodeficiency Diseases (PID)

• Registration Number: NCT02593188
• Lead Sponsor: Baxalta now part of Shire

Brief Summary

The purpose of the proposed study is to acquire additional data (including the assessment of anti-rHuPH20 antibodies) on the long-term safety of HYQVIA and to assess the prescribed treatment regimens and treatment administration in routine clinical practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-11-01
• Study Start: 2015-11-12
• Primary Completion: 2021-10-21
• Study Completion: 2021-10-21
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

1. Participant requires immunoglobulin treatment for primary immunodeficiency disease (PIDD)
2. Participant age is compatible with local package insert requirements
3. Participant has been prescribed or has started treatment with HYQVIA (Immune Globulin (Human) 10% with rHuPH20)
4. Participant is willing and able to comply with the requirements of the protocol.
5. Female participant of child-bearing potential agrees to inform the investigator if she becomes pregnant, or plans to become pregnant during the course of the study

Exclusion Criteria

1. Participant has known hypersensitivity to any of the components of the medicinal product
2. Participant has participated in an interventional clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in an interventional clinical study involving a medical product or device during the course of this study
3. Participant is a family member or employee of the investigator
4. Participant is planning to become pregnant, pregnant or breastfeeding at the time of enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of all SAEs	Throughout the study period of approximately 5 1/2 years
Health resource use: length of hospital stay	Throughout the study period of approximately 5 1/2 years
Incidence of Infections	Throughout the study period of approximately 5 1/2 years
Treatment Administration: Mean rate of infusion	Throughout the study period of approximately 5 1/2 years
Health resource use: hospitalizations	Throughout the study period of approximately 5 1/2 years
Incidence and titer of binding and neutralizing antibodies to rHuPH20	Throughout the study period of approximately 5 1/2 years
Treatment Administration: Maximum infusion rate	Throughout the study period of approximately 5 1/2 years
Health Related Quality of Life: EuroQol 5-Dimension (EQ-5D) Questionnaire	Every 3 months in first year of study, annually for remainder of study
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9)	Every 3 months in first year of study, annually for remainder of study
Health Related Quality of Life: Treatment Preference Questionnaire	Annually throughout the study
Health resource use: acute care visits	Throughout the study period of approximately 5 1/2 years
Days missed from work/school	Throughout the study period of approximately 5 1/2 years
Incidence of all related serious adverse events (SAEs)	Throughout the study period of approximately 5 1/2 years
Treatment Regimen: Infusion interval	Throughout the study period of approximately 5 1/2 years
Treatment Administration: Number of infusion sites per infusion	Throughout the study period of approximately 5 1/2 years
Health Related Quality of Life: Short Form-36 (SF-36)	Every 3 months in first year of study, annually for remainder of study
Health resource use: Emergency Room visits	Throughout the study period of approximately 5 1/2 years
Incidence of non-serious adverse events (AEs), related and not related, local and systemic.	Throughout the study period of approximately 5 1/2 years
Treatment Regimen: Total dose administered	Throughout the study period of approximately 5 1/2 years
Treatment Administration: Actual volume per infusion	Throughout the study period of approximately 5 1/2 years
Treatment Administration: Duration of infusion	Throughout the study period of approximately 5 1/2 years

Trial Locations

Locations (30)

Kern Allergy Medical Clinic; 🇺🇸 Bakersfield, California, United States

University of California Irvine Medical Center; 🇺🇸 Irvine, California, United States

Riviera Allergy Medical Center; 🇺🇸 Redondo Beach, California, United States

Capital Allergy & Respiratory Disease Center; 🇺🇸 Sacramento, California, United States

UCLA School of Medicine; 🇺🇸 Santa Monica, California, United States

Asthma and Allergy Associates, PC; 🇺🇸 Colorado Springs, Colorado, United States

Pikes Peak Allergy and Asthma; 🇺🇸 Colorado Springs, Colorado, United States

IMMUNOe International Research Centers; 🇺🇸 Thornton, Colorado, United States

Georgia Pollens Clinical Research Centers, Inc.; 🇺🇸 Albany, Georgia, United States

Boston Childrens Hospital; 🇺🇸 Boston, Massachusetts, United States

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