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Completed

NCT Number: NCT03369301

The Effect of Subcutaneous Immunoglobulin Gammanorm on the Distribution of IgG Subclasses and on Immunity of Patients With Secondary Immunodeficiency

Patients with Myeloma or CLL with severe secondary hypogammaglobinemia and recurrent infections will be included in this study; for whom an IgSC treatment was prescribed. The IgSC prescription will be the decision of the treating physician. Patient care and follow up will be performed according to the current clinical practice and the recommendations of HAS.

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Key information

Conditions

Secondary Immune Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH William Morey Chalon-sur-Saône, Chalon-sur-Saône, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult male or female (≥18 years old), Myeloma or Chronic Lymphocytic Leukemia patients with secondary hypogammaglobinemia and recurring infections.
  • Patients with indication for IgSC treatment but who have not started the treatment yet. Prior IgSC or IgIV treatment 6 months before inclusion is accepted (with a washout period of 6 months minimum).
  • Patient having received all the necessary information about the study and signed an informed consent document.

Exclusion criteria

  • Patient having initiated an IgSC treatment.
  • Patient having received IgSC or IgIV treatment within 6 months prior to inclusion.
  • Incapacity/Inability to attend the follow-up visits.
  • Patient refusing to participate in the study.
  • HIV positive patients.
  • Incapacity to understand the study objective and process, to agree or to give informed consent to participate in the study.
  • Pregnant or breast-feeding women

Treatment and study plan

Gammanorm

Drug

Gammanorm given per standard of care

Other Subcutaneous Immunoglobulins

Drug

Other Subcutaneous Immunoglobulins given per standard of care

Primary outcomes

  1. Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment

    Time frame: 12 months

    Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment collected as biological data including immunoglobulins (quantitative dosage and electrophoresis), lymphocytes, CD14 monocytes, polynuclear neutrophils, polynuclear basophils and dendritic cells

Secondary outcomes

  1. Change in immune system

    Time frame: 12 months

    To analyze the change in the immune system (CD14 monocytes, polynuclear neutrophils, polynuclear basophils and dendritic cells)

  2. IgG levels

    Time frame: 12 months

    To analyze the IgG levels with respect to the IgSC treatment

  3. Lymphocytic Repertoire analyzing the evolution of the lymphocytic repertoire (CD3, CD4, CD8, CD19, CD56, and CD27).

    Time frame: 12 months

    To analyze the evolution of the lymphocytic repertoire (CD3, CD4, CD8, CD19, CD56, and CD27).

  4. IgSC treatment

    Time frame: 12 months

    To characterize the IgSC treatment duration and the patient management (observance, duration and reason of termination)

  5. Bacterial Infections

    Time frame: 12 months

    To evaluate the severe and non-severe bacterial infection rates

  6. Antibiotic Consumption

    Time frame: 12 months

    To evaluate the antibiotics consumption during the study

  7. Hospitalizations due to infections

    Time frame: 12 months

    Evaluate the hospitalization rates due to infections

  8. Safety of IgSCs to characterize the IgSCs safety, including the adverse events that are not considered to be related to the study treatment

    Time frame: 12 months

    To characterize the IgSCs safety, including the adverse events that are not considered to be related to the study treatment

  9. Predictive Factors of Recurrent Infections

    Time frame: 12 months

    To characterize potential predictive factors or markers of recurrent infections despite of the Ig treatment by collecting information about infections at follow up visits, especially bacterial infections and their respective antibiotherapy

Sponsors and collaborators

Lead sponsor

Octapharma

Industry

Registry information

Official study title

Effect of Subcutaneous Immunoglobulin (IgSC) Gammanorm® on the Distribution of IgG Subclasses and on the Humoral Immunity of Patients With Secondary Immunodeficiency.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2017
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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