## Protocol Section
### Identification Module
**NCT ID:** NCT00157079

**Brief Title:** Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders

**Official Title:** A Clinical Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency Disorders

#### Organization Study ID Info
**ID:** 160101
#### Organization
**Class:** INDUSTRY
**Full Name:** Takeda
### Status Module
#### Completion Date
**Date:** 2003-12-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-08-24

**Type:** ACTUAL

**Last Update Submit Date:** 2021-08-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2003-12-16

**Type:** ACTUAL

#### Start Date
**Date:** 2002-06-25

**Type:** ACTUAL

**Status Verified Date:** 2021-08

#### Study First Post Date
**Date:** 2005-09-12
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-08
**Study First Submit QC Date:** 2005-09-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Baxalta now part of Shire

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Drug:** True

### Description Module

**Brief Summary:** The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.

### Conditions Module

**Conditions:**

- Primary Immunodeficiency Diseases (PID)

- Immune Thrombocytopenic Purpura (ITP)

- Kawasaki Syndrome

**Keywords:**

- PID

- Immunodeficiency

- Immune Thrombocytopenic Purpura (ITP)

- Kawasaki syndrome

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 61

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Immune Globulin Intravenous (Human), 10%

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Mean number of acute serious bacterial infections per participant per year

**Time Frame:** Throughout the study period of 18 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration
* Diagnosis of a PID disorder as defined by World Health Organization criteria for which the subject has been receiving a regimen of IGIV infusions every 21 to 28 days over a period of at least 4 months pre-study at a dose of 300-600 mg/kg body weight
* Subjects \> 24 months of age
* A negative serum pregnancy test for any female subject who is of childbearing potential.

Exclusion Criteria:

* Subjects sero-positive at enrollment for one or more of the following: hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (HCV), antibodies to human immunodeficiency virus (HIV) Types 1 or 2
* Subjects with levels of alanine amino transferase (ALT) and aspartate amino transferase (AST) \> 2.5 times the upper limit of normal for the testing laboratory. An AST \> 2.5 times the upper limit of normal is allowable, if the ALT does not exceed the upper limit of the reference range for the testing laboratory
* Subjects with neutropenia (defined as an ANC \>= 1,000/mm3)
* Subjects with serum creatinine levels greater than two times the upper limit of normal for age and gender
* Subjects with malignancy or a history of malignancy
* Subjects who received any blood or blood product exposure other than an IGIV and/or immune serum globulin (ISG) preparation within the 6 months prior to study entry
* Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV and/or ISG infusions
* Subjects with selective complete IgA deficiency
* Subjects with moderate levels of anti-IgA antibodies (\>150), or subjects with lower anti-IgA antibodies who are naive to IGIV treatment. (Subjects with lower levels of IgA antibodies, whom the investigators know to have tolerated IgA containing IGIV preparations in the past, may be included if the investigator is comfortable with this)
* Subjects receiving antibiotic therapy for the treatment of infection within 30 days prior to enrollment
* Subjects who receive prophylactic antibiotics as part of their care regimen
* Subjects participating in another clinical study involving an investigational product or device within 30 days prior to study entry

**Minimum Age:** 24 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** Children´s Hospital Los Angeles

**State:** California

**Zip:** 90027

**Location 2:**

**City:** Stanford

**Country:** United States

**Facility:** Stanford University Medical Center

**State:** California

**Zip:** 94304-8786

**Location 3:**

**City:** Englewood

**Country:** United States

**Facility:** 1st Allergy and Clinical Research Center

**State:** Colorado

**Zip:** 80112

**Location 4:**

**City:** North Palm Beach

**Country:** United States

**Facility:** Allergy Associates of the Palm Beaches

**State:** Florida

**Zip:** 33408

**Location 5:**

**City:** Tampa

**Country:** United States

**Facility:** University of South Florida; Asthma, Allergy & Immunology CRU

**State:** Florida

**Zip:** 33613

**Location 6:**

**City:** Chicago

**Country:** United States

**Facility:** Rush Presbyterian - St. Lukes Medical Center

**State:** Illinois

**Zip:** 60612

**Location 7:**

**City:** Boston

**Country:** United States

**Facility:** Children´s Hospital Boston

**State:** Massachusetts

**Zip:** 02115

**Location 8:**

**City:** Omaha

**Country:** United States

**Facility:** Allergy, Asthma & Immunology Assoc.

**State:** Nebraska

**Zip:** 68124

**Location 9:**

**City:** Papillion

**Country:** United States

**Facility:** Asthma and Allergy Center

**State:** Nebraska

**Zip:** 68046

**Location 10:**

**City:** Bronx

**Country:** United States

**Facility:** Montefiore Medical Center, Albert Einstein College of Medicine

**State:** New York

**Zip:** 10461

**Location 11:**

**City:** Dallas

**Country:** United States

**Facility:** Pediatric Allergy/Immunology Associates

**State:** Texas

**Zip:** 75230

#### Overall Officials

**Official 1:**

**Affiliation:** Takeda

**Name:** Study Director

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000007154

- Term: Immune System Diseases

- ID: D000001778

- Term: Blood Coagulation Disorders

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000006470

- Term: Hemorrhage

- ID: D000012877

- Term: Skin Manifestations

- ID: D000057049

- Term: Thrombotic Microangiopathies

- ID: D000013921

- Term: Thrombocytopenia

- ID: D000001791

- Term: Blood Platelet Disorders

- ID: D000095542

- Term: Cytopenia

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000006474

- Term: Hemorrhagic Disorders

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000014657

- Term: Vasculitis

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000017445

- Term: Skin Diseases, Vascular

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18945

- Name: Purpura, Thrombocytopenic, Idiopathic

- Relevance: HIGH

- As Found: Immune Thrombocytopenic Purpura

- ID: M14547

- Name: Purpura

- Relevance: HIGH

- As Found: Purpura

- ID: M14550

- Name: Purpura, Thrombocytopenic

- Relevance: HIGH

- As Found: Thrombocytopenic Purpura

- ID: M10199

- Name: Immunologic Deficiency Syndromes

- Relevance: HIGH

- As Found: Immunodeficiency

- ID: M2285

- Name: Primary Immunodeficiency Diseases

- Relevance: HIGH

- As Found: Primary Immunodeficiency

- ID: M12039

- Name: Mucocutaneous Lymph Node Syndrome

- Relevance: HIGH

- As Found: Kawasaki Syndrome

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21977

- Name: Hemostatic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5059

- Name: Blood Coagulation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

- ID: M15680

- Name: Skin Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M28682

- Name: Thrombotic Microangiopathies

- Relevance: LOW

- As Found: Unknown

- ID: M16680

- Name: Thrombocytopenia

- Relevance: LOW

- As Found: Unknown

- ID: M5072

- Name: Blood Platelet Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M3170

- Name: Cytopenia

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M9560

- Name: Hemorrhagic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17405

- Name: Vasculitis

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19714

- Name: Skin Diseases, Vascular

- Relevance: LOW

- As Found: Unknown

- ID: T3021

- Name: Immune Thrombocytopenia

- Relevance: HIGH

- As Found: Immune Thrombocytopenic Purpura

- ID: T3007

- Name: Idiopathic Thrombocytopenic Purpura

- Relevance: HIGH

- As Found: Immune Thrombocytopenic Purpura

- ID: T3211

- Name: Kawasaki Disease

- Relevance: HIGH

- As Found: Kawasaki Syndrome

### Condition Browse Module - Meshes

- ID: D000009080

- Term: Mucocutaneous Lymph Node Syndrome

- ID: D000011693

- Term: Purpura

- ID: D000011696

- Term: Purpura, Thrombocytopenic

- ID: D000016553

- Term: Purpura, Thrombocytopenic, Idiopathic

- ID: D000081207

- Term: Primary Immunodeficiency Diseases

- ID: D000007153

- Term: Immunologic Deficiency Syndromes

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: HIGH

- As Found: Cap

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: HIGH

- As Found: Cap

- ID: M19117

- Name: Immunoglobulins, Intravenous

- Relevance: HIGH

- As Found: Active exercises

- ID: M8836

- Name: gamma-Globulins

- Relevance: HIGH

- As Found: Dronabinol

- ID: M20191

- Name: Rho(D) Immune Globulin

- Relevance: HIGH

- As Found: Dronabinol

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007136

- Term: Immunoglobulins

- ID: D000000906

- Term: Antibodies

- ID: D000005719

- Term: gamma-Globulins

- ID: D000016756

- Term: Immunoglobulins, Intravenous

- ID: D000018029

- Term: Rho(D) Immune Globulin

### Misc Info Module

- Version Holder: 2024-05-24
