Clinical trial

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

Name

161406

Description

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.

Trial arms

Trial start

2015-11-12

Estimated PCD

2021-10-21

Trial end

2021-10-21

Status

Completed

Treatment

HYQVIA

Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

Arms:

HYQVIA- Epoch 1, HYQVIA- Epoch 2

Size

264

Primary endpoint

Incidence of all related serious adverse events (SAEs)

Throughout the study period of approximately 5 1/2 years

Incidence of all SAEs

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

Incidence of Infections

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 Regimen: Total dose administered

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: Actual volume per infusion

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

Treatment Administration: Mean rate of 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

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 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: hospitalizations

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

Health resource use: acute care visits

Throughout the study period of approximately 5 1/2 years

Health resource use: Emergency Room 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

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples (plasma) for antibodies against recombinant human hyaluronidase (rHuPH20) that remain after study testing will be stored at the Central Laboratory to confirm implausible or critical test results, if required. Samples will be stored in a coded form and according to local requirements for a maximum of 2 years after the final study report has been completed and subsequently will be destroyed.'}, 'enrollmentInfo': {'count': 264, 'type': 'ACTUAL'}}

Updated at

2022-10-18

1 organization

1 product

1 indication

Organization

Shire

Product

HYQVIA

Indication

Primary Immunodeficiency Diseases