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

NCT02593188 | Completed

• 2 other identifiers: 161406EUPAS21523
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 30

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.

Conditions

Primary Immunodeficiency Diseases (PID)

Outcome Measures

Primary Outcomes (21)

• 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

Study Arms (2)

HYQVIA- Epoch 1

Participants receiving HYQVIA

Biological: HYQVIA

HYQVIA- Epoch 2

Participants with rHuPH antibody titers ≥160 (tested in Epoch 1)

Biological: HYQVIA

Interventions

HYQVIA BIOLOGICAL

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

HYQVIA- Epoch 1; HYQVIA- Epoch 2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant requires immunoglobulin treatment for primary immunodeficiency disease (PIDD)
• Participant age is compatible with local package insert requirements
• Participant has been prescribed or has started treatment with HYQVIA (Immune Globulin (Human) 10% with rHuPH20)
• Participant is willing and able to comply with the requirements of the protocol.
• 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

You may not qualify if:

• Participant has known hypersensitivity to any of the components of the medicinal product
• 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
• Participant is a family member or employee of the investigator
• Participant is planning to become pregnant, pregnant or breastfeeding at the time of enrollment

Sponsors & Collaborators

• Baxalta now part of Shire: lead

Study Sites (30)

Kern Allergy Medical Clinic

Bakersfield, California, 93301, United States

Location

University of California Irvine Medical Center

Irvine, California, 92697, United States

Location

Riviera Allergy Medical Center

Redondo Beach, California, 90277, United States

Location

Capital Allergy & Respiratory Disease Center

Sacramento, California, 95819, United States

Location

UCLA School of Medicine

Santa Monica, California, 90404, United States

Location

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, 80907, United States

Location

Pikes Peak Allergy and Asthma

Colorado Springs, Colorado, 80920, United States

Location

IMMUNOe International Research Centers

Thornton, Colorado, 80233, United States

Location

Georgia Pollens Clinical Research Centers, Inc.

Albany, Georgia, 31707, United States

Location

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

Location

Canton Health Center

Canton, Michigan, 48187-5097, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Corning Center for Clinical Research

Corning, New York, 14830, United States

Location

Northwell Health, Inc. PRIME

Great Neck, New York, 11021, United States

Location

Winthrop University

Mineola, New York, 11501, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Carolinas Healthcare System

Charlotte, North Carolina, 28203, United States

Location

Allergy Asthma & Immunology Relief of Charlotte

Charlotte, North Carolina, 28277, United States

Location

Optimed Research, LTD

Columbus, Ohio, 43235, United States

Location

Allergy, Asthma and Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

OK Institute of Allergy & Asthma Clinical Research, LLC

Oklahoma City, Oklahoma, 73131, United States

Location

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, 74136, United States

Location

Allergy & Clinical Immunology Associates

Pittsburgh, Pennsylvania, 15241, United States

Location

National Allergy, Asthma & Urticaria Centers of Charleston, PA

North Charleston, South Carolina, 29420-4211, United States

Location

Allergy / Immunology Research Center of North Texas

Dallas, Texas, 75230, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

McKinney Allergy and Asthma Center

McKinney, Texas, 75070, United States

Location

Greater Austin Allergy, Asthma, & Immunology

Round Rock, Texas, 78664-5226, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Links

• To obtain more information on the study, click here/on this link.

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Shire Director

  Shire

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 2, 2015
• Study Start: November 12, 2015
• Primary Completion: October 21, 2021
• Study Completion: October 21, 2021
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (30)