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

• Sponsor: Octapharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03369301
• Collaborator: (none)
• Enrollment: 102
• Locations: 6
• Actual Duration (Months): 25.9
• Patients Per Site: 17
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Secondary Immune Deficiency	Drug: Gammanorm; Drug: Other Subcutaneous Immunoglobulins

Study Design

• Study Type: Observational
• Actual Enrollment: 102 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Effect of Subcutaneous Immunoglobulin (IgSC) Gammanorm® on the Distribution of IgG Subclasses and on the Humoral Immunity of Patients With Secondary Immunodeficiency.
• Actual Study Start Date: Sep 25, 2017
• Actual Primary Completion Date: Nov 22, 2019
• Actual Study Completion Date: Nov 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Gammanorm Patients on Gammanorm per standard of care	Drug: Gammanorm; Gammanorm given per standard of care
Other Subcutaneous Immunoglobulin Patients on subcutaneous immunoglobulin treatments other than Gammanorm	Drug: Other Subcutaneous Immunoglobulins; Other Subcutaneous Immunoglobulins given per standard of care

Outcome Measures

Primary Outcome Measures

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

1. Change in immune system [12 months]

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

2. IgG levels [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). [12 months]

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

4. IgSC treatment [12 months]

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

5. Bacterial Infections [12 months]

   To evaluate the severe and non-severe bacterial infection rates

6. Antibiotic Consumption [12 months]

   To evaluate the antibiotics consumption during the study

7. Hospitalizations due to infections [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adult male or female (≥18 years old), Myeloma or Chronic Lymphocytic Leukemia patients with secondary hypogammaglobinemia and recurring infections.

2. 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).

3. Patient having received all the necessary information about the study and signed an informed consent document.

Exclusion Criteria:

1. Patient having initiated an IgSC treatment.

2. Patient having received IgSC or IgIV treatment within 6 months prior to inclusion.

3. Incapacity/Inability to attend the follow-up visits.

4. Patient refusing to participate in the study.

5. HIV positive patients.

6. Incapacity to understand the study objective and process, to agree or to give informed consent to participate in the study.

7. Pregnant or breast-feeding women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CH William Morey Chalon-sur-Saône	Chalon-sur-Saône		France	71100
2	CHD Vendée	La Roche-sur-Yon		France	85000
3	CH la Rochelle - Hôpital Saint Louis	La Rochelle		France	17000
4	CH Orléans	Orléans		France	45100
5	CHU Bordeaux Centre François Magendie Hopital Haut -Lévêque	Pessac		France	33604
6	CH Saint Malo	Saint-Malo		France	35400

Sponsors and Collaborators

• Octapharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Octapharma
• ClinicalTrials.gov Identifier: NCT03369301
• Other Study ID Numbers: Optinorm
• First Posted: Dec 12, 2017
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasm Metastasis; Immunologic Deficiency Syndromes; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies

Study Results

No Results Posted as of Mar 2, 2022