Facilitated Immunoglobulin Administration Registry and Outcomes Study (FIGARO)

NCT03054181 | Completed

• 1 other identifier: FIGARO
• Study Type: observational
• Target: 156
• Locations: 3 countries
• Sites: 4

Brief Summary

Long-term observational study on the utilisation and outcomes of HyQvia (a product consisting of recombinant human hyaluronidase and a human normal immunoglobulin 10% solution) under everyday clinical practice conditions.

Conditions

Primary Immunodeficiency; Secondary Immune Deficiency

Keywords

Observational; Infection; Utilisation; Safety; Tolerability; Infusion; chronic

Outcome Measures

Primary Outcomes (1)

• Utilisation in terms of dose and dosing interval

  mean monthly dose

  up to 3 years

Secondary Outcomes (7)

• Adverse events

  up to 3 years

• Concomitant diseases

  up to 3 years

• mean immunoglobulin trough level

  up to 3 years

• Number of participants with treatment-related adverse events

  up to 3 years

• Number of training session

  up to 3 years

Study Arms (1)

HyQvia

Recombinant human hyaluronidase and normal immunoglobulin 10%

Biological: HyQvia

Interventions

HyQvia BIOLOGICAL

Also known as: Recombinant human hyaluronidase and normal immunoglobulin 10%

HyQvia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary (PID) or secondary immunodeficiencies (SID)

You may qualify if:

• Patient has received/will receive at least 1 HyQvia infusion for PID or SID
• Patient has an indication for chronic immunoglobulin treatment
• Patient is likely available for long-term documentation
• Patient provides informed consent for documentation

Sponsors & Collaborators

• GWT-TUD GmbH: lead

Study Sites (4)

University Hospital

Paris, France

Location

Charité

Berlin, Germany

Location

Hospital for Children and Adolescents, St. Georg Hospital, Academic Teaching Hospital

Leipzig, Germany

Location

La Sapienza University

Roma, Italy

Location

Related Publications (1)

• Borte M, Hanitsch LG, Mahlaoui N, Fasshauer M, Huscher D, Speletas M, Dimou M, Kamieniak M, Hermann C, Pittrow D, Milito C. Facilitated Subcutaneous Immunoglobulin Treatment in Patients with Immunodeficiencies: the FIGARO Study. J Clin Immunol. 2023 Aug;43(6):1259-1271. doi: 10.1007/s10875-023-01470-2. Epub 2023 Apr 10.

  PMID: 37036560 RESULT

MeSH Terms

Conditions

Primary Immunodeficiency Diseases; Infections; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

Study Officials

• Michael Borte, MD, PhD

  Fachbereich Pädiatrische Rheumatologie, Immunologie und Infektiologie am Klinikum St. Georg Leipzig

  PRINCIPAL INVESTIGATOR

• David Pittrow, MD

  GWT-TUD GmbH, Dresden, Germany

  STUDY DIRECTOR

• Isabelle Quinti, MD

  Sapienza University Rome, Italy

  STUDY CHAIR

• Leif Hanitsch, MD

  Charité Berlin, Germany

  STUDY CHAIR

• Nizar Mahlaoui, MD

  University Hospital, Paris, France

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 15, 2017
• Study Start: December 22, 2016
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: September 14, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); FR (1); IT (1)