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

NCT03369301 | Completed FDA Drug

• 1 other identifier: Optinorm
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Secondary Immune Deficiency

Outcome Measures

Primary Outcomes (1)

• Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment

  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

  12 months

Secondary Outcomes (9)

• Change in immune system

  12 months

• IgG levels

  12 months

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

  12 months

• IgSC treatment

  12 months

• Bacterial Infections

  12 months

Study Arms (2)

Gammanorm

Patients on Gammanorm per standard of care

Drug: Gammanorm

Other Subcutaneous Immunoglobulin

Patients on subcutaneous immunoglobulin treatments other than Gammanorm

Drug: Other Subcutaneous Immunoglobulins

Interventions

Gammanorm DRUG

Gammanorm given per standard of care

Gammanorm

Other Subcutaneous Immunoglobulins DRUG

Other Subcutaneous Immunoglobulins given per standard of care

Other Subcutaneous Immunoglobulin

Eligibility Criteria

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

Study Population

Every eligible patient for the selection criteria will be consecutively included in the study to avoid any selection bias.

You may qualify if:

• Adult male or female (≥18 years old), Myeloma or Chronic Lymphocytic Leukemia patients with secondary hypogammaglobinemia and recurring infections.
• Patient having received all the necessary information about the study and signed an informed consent document.

You may not qualify if:

• Patient having initiated an IgSC treatment.
• 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

Sponsors & Collaborators

• Octapharma: lead

Study Sites (6)

CH William Morey Chalon-sur-Saône

Chalon-sur-Saône, 71100, France

Location

CHD Vendée

La Roche-sur-Yon, 85000, France

Location

CH la Rochelle - Hôpital Saint Louis

La Rochelle, 17000, France

Location

CH Orléans

Orléans, 45100, France

Location

CHU Bordeaux Centre François Magendie Hopital Haut -Lévêque

Pessac, 33604, France

Location

CH Saint Malo

St-Malo, 35400, France

Location

Study Design

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

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 12, 2017
• Study Start: September 25, 2017
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

FR (6)