Facilitated Immunoglobulin Administration Registry and Outcomes Study (FIGARO) (FIGARO)
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|ClinicalTrials.gov Identifier: NCT03054181|
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : February 22, 2019
|Condition or disease||Intervention/treatment|
|Primary Immunodeficiency Secondary Immune Deficiency||Biological: HyQvia|
Recombinant hyaluronidase is an established therapeutic principle to facilitate the infusion of large volumes of fluids subcutaneously (e.g. Ringer solution and antibodies such as IG, rituximab, trastuzumab).
HyQvia is a product consisting of recombinant human hyaluronidase (rHuPH20, Hylenex®), and a human normal immunoglobulin (IG). The subcutaneous (SC) IG is a 10% solution prepared from human plasma consisting of at least 98% immunoglobulin G, which contains a broad spectrum of antibodies.
The two components are packaged together as a dual vial unit: IG provides the therapeutic effect and the recombinant human hyaluronidase facilitates the dispersion, which alters the kinetics of absorption and increases the bioavailability of the IG.
HyQvia is marketed in the European Union (EU) since July 2013 and in the USA since September 2014. In the EU, HyQvia is indicated as replacement therapy in patients of all age groups in primary immunodeficiency syndromes (PID), and in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections (secondary immunodeficiency syndromes, SID), as well as hypogammaglobulinaemia and pre- and post-allogeneic hematopoietic stem cell transplantation.
HyQvia was investigated in one pivotal study lasting over a year, involving 89 patients with PID who had already had treatment with human normal IG for at least three months. The number of acute serious bacterial infections (SBI) as main efficacy outcomes was 0.025 per year. This was below the FDA predefined number needed to show efficacy (SBI rate <1.0 per subject per year at the 0.01 level of significance), and was similar to that seen with other licensed human normal IG products. In the pivotal study and its extension, 188 patient years under HyQvia treatment have been documented. HyQvia was efficacious, safe, and bioequivalent to intravenous IG at the same administration intervals, but it caused fewer systemic reactions. Tolerability was good despite high infusion volumes and rates. There are no preclinical data that suggest an increased risk of mutagenicity, teratogenicity, fertility or neuronal development.
The most current and comprehensive data on real-life utilisation and outcomes of various IgG preparations is available from the German SIGNS registry. This registry confirmed the effectiveness of IgG substitution or treatment in terms of reduction of infections (PID and SID), as well as stabilization or improvement of the clinical condition in neurological and autoimmune diseases. In a cohort of 24 PID and SID patients on HyQvia in the German SIGNS study, the preparation was well tolerated and treatment satisfaction was high. In other countries, data on the utilisation and outcomes of HyQvia under clinical practice conditions are sparse or completely missing.
The present study aims to fill these gaps and to provide a detailed and complete description of the utilisation of under everyday clinical practice conditions.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Facilitated Immunoglobulin Administration Registry and Outcomes Study|
|Actual Study Start Date :||December 22, 2016|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||March 31, 2020|
Recombinant human hyaluronidase and normal immunoglobulin 10%
Other Name: Recombinant human hyaluronidase and normal immunoglobulin 10%
- Utilisation in terms of dose and dosing interval [ Time Frame: up to 3 years ]mean monthly dose
- Adverse events [ Time Frame: up to 3 years ]Incidence and type
- Concomitant diseases [ Time Frame: up to 3 years ]
- mean immunoglobulin trough level [ Time Frame: up to 3 years ]after HyQvia infusion
- Number of participants with treatment-related adverse events [ Time Frame: up to 3 years ]Acute bacterial infections; overall infections
- Number of training session [ Time Frame: up to 3 years ]about appropriate self-infusion
- Number of days in hospital [ Time Frame: up to 3 years ]
- Number of days in rehabilitation clinic [ Time Frame: up to 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054181
|Contact: David Pittrow, MD, PhD||+49 351 25933 ext email@example.com|
|Contact: Romy Hoppenz||+49 351 25933 ext firstname.lastname@example.org|
|University Hospital||Not yet recruiting|
|Contact: Nizar Mahlaoui, MD|
|Charité||Not yet recruiting|
|Contact: Leif Hanitsch, MD|
|Hospital for Children and Adolescents, St. Georg Hospital, Academic Teaching Hospital||Recruiting|
|Contact: Maria Fasshauer, MD +49-341-909 ext 3660 Maria.Fasshauer@SanktGeorg.DE|
|Principal Investigator: Michael Borte, MD|
|La Sapienza University||Not yet recruiting|
|Contact: Isablle Quinti, MD|
|Principal Investigator:||Michael Borte, MD, PhD||Fachbereich Pädiatrische Rheumatologie, Immunologie und Infektiologie am Klinikum St. Georg Leipzig|
|Study Director:||David Pittrow, MD||GWT-TUD GmbH, Dresden, Germany|
|Study Chair:||Isabelle Quinti, MD||Sapienza University Rome, Italy|
|Study Chair:||Leif Hanitsch, MD||Charité, Berlin, Germany|
|Study Chair:||Nizar Mahlaoui, MD||University Hospital, Paris, France|