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Facilitated Immunoglobulin Administration Registry and Outcomes Study (FIGARO) (FIGARO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054181
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH

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.

Condition or disease Intervention/treatment
Primary Immunodeficiency Secondary Immune Deficiency Biological: HyQvia

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
HyQvia
Recombinant human hyaluronidase and normal immunoglobulin 10%
Biological: HyQvia
Other Name: Recombinant human hyaluronidase and normal immunoglobulin 10%




Primary Outcome Measures :
  1. Utilisation in terms of dose and dosing interval [ Time Frame: up to 3 years ]
    mean monthly dose


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: up to 3 years ]
    Incidence and type

  2. Concomitant diseases [ Time Frame: up to 3 years ]
  3. mean immunoglobulin trough level [ Time Frame: up to 3 years ]
    after HyQvia infusion

  4. Number of participants with treatment-related adverse events [ Time Frame: up to 3 years ]
    Acute bacterial infections; overall infections

  5. Number of training session [ Time Frame: up to 3 years ]
    about appropriate self-infusion

  6. Number of days in hospital [ Time Frame: up to 3 years ]
  7. Number of days in rehabilitation clinic [ Time Frame: up to 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary (PID) or secondary immunodeficiencies (SID)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • No explicit exclusion criteria apply.

Information from the National Library of Medicine

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


Contacts
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Contact: David Pittrow, MD, PhD +49 351 25933 ext 182 david.pittrow@mailbox.tu-dresden.de
Contact: Romy Hoppenz +49 351 25933 ext 182 romy.hoppenz@gwtonline.de

Locations
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France
University Hospital Not yet recruiting
Paris, France
Contact: Nizar Mahlaoui, MD         
Germany
Charité Not yet recruiting
Berlin, Germany
Contact: Leif Hanitsch, MD         
Hospital for Children and Adolescents, St. Georg Hospital, Academic Teaching Hospital Recruiting
Leipzig, Germany
Contact: Maria Fasshauer, MD    +49-341-909 ext 3660    Maria.Fasshauer@SanktGeorg.DE   
Principal Investigator: Michael Borte, MD         
Italy
La Sapienza University Not yet recruiting
Roma, Italy
Contact: Isablle Quinti, MD         
Sponsors and Collaborators
GWT-TUD GmbH
Investigators
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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
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Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT03054181    
Other Study ID Numbers: FIGARO
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GWT-TUD GmbH:
Observational
Infection
Utilisation
Safety
Tolerability
Infusion
chronic
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs