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A Clinical Study of Intravenous Immunoglobulin (IGIV)

Primary Purpose

Immunologic Deficiency Syndromes

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Immune Globulin Intravenous (Human) Omr-IgG-am IGIV

About this trial

This is an interventional prevention trial for Immunologic Deficiency Syndromes focused on measuring Deficiency Syndromes, Antibody, Antibody Deficiency Syndrome, Bruton's agammaglobulinemia, Common Variable Immune Deficiency, Hyper IgM syndromes

Eligibility Criteria

3 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

The following list is incomplete. A complete list is in the protocol.

Inclusion Criteria:

Ages 3 to 75 years and weigh at least 27 kg.
Confirmed clinical diagnosis of a Primary Immune Deficiency disease including hypogammaglobulinemia, preferably with documented antibody deficiency, or agammaglobulinemia.
Has been receiving licensed IGIV for at least 3 months prior to this study.
Trough IgG levels, dose of IGIV, and treatment intervals for the last 2 consecutive licensed IGIV treatments must be documented.
The subject or legal guardian has signed the informed consent form. If appropriate, the subject has signed a child assent form.
The subject or legal representative has signed the HIPAA declaration.

Exclusion Criteria:

Subjects with isolated IgG subclass deficiency or specific antibody deficiency without hypogammaglobulinemia will not be eligible.
The subject has a history of hypersensitivity or persistent or repeated adverse reactions to human immunoglobulin.
The subject has selective IgA deficiency, history of reaction to products containing IgA, or is known to have antibodies to IgA.
The subject is currently participating, or has participated within the previous 30 days, in another clinical study of an investigational product or device.
The subject is pregnant or is nursing. Women of childbearing potential must agree to using a method of contraception.
The subject has had an acute bacterial infection within 28 days of screening.
The subject is seropositive for any of the following at screening:
Antibodies to HIV 1&2
Antibodies to HCV
HbsAg
The subject, at screening, has alanine aminotransferase (ALT) levels greater than 2.5 times the upper limit of normal.
The subject has severe renal impairment.
The subject has a history of DVT, thrombotic or thrombic complications of IGIV therapy.
The subject suffers from any acute or chronic medical condition that, in the opinion of the investigator, may interfere with the conduct of the study.
The subject has an acquired medical condition known to cause secondary immune deficiency or otherwise increase the subject's risk of infection.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravenous Immune Globulin

Arm Description

Subjects with primary humoral immunodeficiency

Outcomes

Primary Outcome Measures

Incidence of acute serious bacterial infections

Acute serious bacterial infections are defined in The FDA(CBER) Guidance for industry for studies of IGIV to support marketing of IGIV as replacement therapy for primary humoral immunodeficiency (June, 2008).

Secondary Outcome Measures

The number of hospitalizations and days of hospitalization per subject per year for PID related infections

The incidence of infections other than acute serious bacterial infections

The number of days lost from work/school/usual activities

The number of days of antibiotic therapy (prophylactic and treatment)

Pharmacokinetic parameters of IgG subclasses and specific antibodies will be determined in at least 20 patients: AUC0-t, Cmax, Tmax, t1/2, Vd and elimination rate constants.

Trough levels of IgG subclasses and specific antibodies will be estimated for each subject in the pharmacokinetic study at defined intervals.

The number of patients whose trough IgG levels fall below the target of 500 mg/dL at any time will be recorded.

All adverse events that occur during the study regardless of the investigator's assessment of the relationship to the investigational product.

Laboratory assessments on blood and urine samples including direct antiglobulin (Coomb's) tests.

Markers of blood borne virus infections at baseline and up to 3 months after the last infusion i.e. HIV (serology), HCV (serology and NAT), HBV (HbsAg).

Full Information

NCT ID

NCT00468273

First Posted

May 1, 2007

Last Updated

August 7, 2014

Sponsor

FFF Enterprises

Collaborators

OMRIX Biopharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00468273

Brief Title

A Clinical Study of Intravenous Immunoglobulin

Acronym

IGIV

Official Title

A Clinical Study of Immune Globulin Intravenous (Human) Omr-IgG-am IGIV in Subjects With Primary Immune Deficiency Diseases

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

FFF Enterprises

Collaborators

OMRIX Biopharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to measure the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human) [IGIV], 5% Solution Omr-IgG-am™ in patients with primary immunodeficiency diseases.

Detailed Description

This is an open label, single-arm, prospective, multi-center, uncontrolled Phase III clinical study to evaluate the efficacy, pharmacokinetics and safety of Omr-IgG-am™ in patients with primary immunodeficiency diseases. Approximately 50 subjects will be enrolled for 16 Months: screening- 1 month treatment-12 months follow-up-3 months Subjects will be infused every 21 to 28 days according to their previous IVIG treatment schedule. Subjects treated every 28 days will receive 13 study IGIV infusions. Subjects treated every 21 days will receive 17 study IGIV infusions. We will record the incidence of acute infections, especially acute serious bacterial infections, during the year each subjet is on study. We will record the incidence of adverse events that occur during each infusion and up to 48 hours after each infusion. At the time the study is explained to the subjects, each investigator will ask all subjects whose body weight is above 37 kg (or greater as defined by local standards) about their willingness to participate in the pharmacokinetic (PK) portion of the study. This will involve 4 additional visits after the 5th or 6th study IGIV infusion in order to draw blood samples for analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immunologic Deficiency Syndromes

Keywords

Deficiency Syndromes, Antibody, Antibody Deficiency Syndrome, Bruton's agammaglobulinemia, Common Variable Immune Deficiency, Hyper IgM syndromes

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intravenous Immune Globulin

Arm Type

Experimental

Arm Description

Subjects with primary humoral immunodeficiency

Intervention Type

Drug

Intervention Name(s)

Immune Globulin Intravenous (Human) Omr-IgG-am IGIV

Intervention Description

IGIV infusions of 300-900 mg/kg every 3 or 4 weeks

Primary Outcome Measure Information:

Title

Incidence of acute serious bacterial infections

Description

Time Frame

one year

Secondary Outcome Measure Information:

Title

The number of hospitalizations and days of hospitalization per subject per year for PID related infections

Time Frame

during treatment with study drug-1 year

Title

The incidence of infections other than acute serious bacterial infections

Time Frame

during treatment with study drug-1 year

Title

The number of days lost from work/school/usual activities

Time Frame

during treatment with study drug-1 year

Title

The number of days of antibiotic therapy (prophylactic and treatment)

Time Frame

during treatment with study drug-1 year

Title

Pharmacokinetic parameters of IgG subclasses and specific antibodies will be determined in at least 20 patients: AUC0-t, Cmax, Tmax, t1/2, Vd and elimination rate constants.

Time Frame

after 5th or 6th study infusion

Title

Trough levels of IgG subclasses and specific antibodies will be estimated for each subject in the pharmacokinetic study at defined intervals.

Time Frame

Months 0, 5, 9, 12

Title

The number of patients whose trough IgG levels fall below the target of 500 mg/dL at any time will be recorded.

Time Frame

one year

Title

All adverse events that occur during the study regardless of the investigator's assessment of the relationship to the investigational product.

Time Frame

one year

Title

Laboratory assessments on blood and urine samples including direct antiglobulin (Coomb's) tests.

Time Frame

one year

Title

Markers of blood borne virus infections at baseline and up to 3 months after the last infusion i.e. HIV (serology), HCV (serology and NAT), HBV (HbsAg).

Time Frame

Months -1, 14, 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

The following list is incomplete. A complete list is in the protocol. Inclusion Criteria: Ages 3 to 75 years and weigh at least 27 kg. Confirmed clinical diagnosis of a Primary Immune Deficiency disease including hypogammaglobulinemia, preferably with documented antibody deficiency, or agammaglobulinemia. Has been receiving licensed IGIV for at least 3 months prior to this study. Trough IgG levels, dose of IGIV, and treatment intervals for the last 2 consecutive licensed IGIV treatments must be documented. The subject or legal guardian has signed the informed consent form. If appropriate, the subject has signed a child assent form. The subject or legal representative has signed the HIPAA declaration. Exclusion Criteria: Subjects with isolated IgG subclass deficiency or specific antibody deficiency without hypogammaglobulinemia will not be eligible. The subject has a history of hypersensitivity or persistent or repeated adverse reactions to human immunoglobulin. The subject has selective IgA deficiency, history of reaction to products containing IgA, or is known to have antibodies to IgA. The subject is currently participating, or has participated within the previous 30 days, in another clinical study of an investigational product or device. The subject is pregnant or is nursing. Women of childbearing potential must agree to using a method of contraception. The subject has had an acute bacterial infection within 28 days of screening. The subject is seropositive for any of the following at screening: Antibodies to HIV 1&2 Antibodies to HCV HbsAg The subject, at screening, has alanine aminotransferase (ALT) levels greater than 2.5 times the upper limit of normal. The subject has severe renal impairment. The subject has a history of DVT, thrombotic or thrombic complications of IGIV therapy. The subject suffers from any acute or chronic medical condition that, in the opinion of the investigator, may interfere with the conduct of the study. The subject has an acquired medical condition known to cause secondary immune deficiency or otherwise increase the subject's risk of infection.

Overall Study Officials: