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Phase 2/3 Study of IGSC, 20% in PIDD | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Phase 2/3 Study of IGSC, 20% in PIDD

A Clinical Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD)

NCT01218438•Baxalta now part of Shire

View on ClinicalTrials.gov

Summary

The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).

Eligibility

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documented diagnosis of a form of primary humoral immunodeficiency involving defective antibody formation and requiring gammaglobulin replacement as defined according to the IUIS Scientific Committee, 2011 and by diagnostic criteria according to Conley et al. (1999). The diagnosis must be confirmed by the Medical Director prior to first treatment with the investigational product (IP) in the study.
•Participant is 2 years or older at the time of screening, and has a minimum body weight of 13 kg.
•Written informed consent has been obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration
•Participant has been receiving a stable monthly equivalent dose of IgG at an average minimum dose equivalent to 300 mg/kg bodyweight (BW)/4 weeks and a maximum dose equivalent to 1.0 gram/kg BW/4 weeks, for a minimum of 12 weeks prior to first treatment with the IP in the study.
•Serum trough level of IgG \> 500 mg/dL at screening
•Participant is willing and able to comply with the requirements of the protocol

Exclusion Criteria

•Participant has known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for Hepatitis C virus(HCV), PCR for human immunodeficiency virus (HIV) Type 1/2
•Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent):
•* Persistent alanine aminotransferase (ALT) and aspartate amino transferase(AST) \> 2.5 times the upper limit of normal for the testing laboratory
•* Persistent severe neutropenia (defined as an absolute neutrophil count \[ANC\] ≤500/mm\^3)
•Creatinine clearance (CLcr) value that is \< 60% of normal for age and gender either measured, or calculated according to the Cockcroft-Gault formula
•Malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), unless the disease-free period prior to screening exceeds 5 years
•Participant is receiving anti-coagulation therapy (low dose aspirin at ≤325 mg/day is permitted) or has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) or sickle cell disease with crisis within 12 months prior to screening or a history of thrombophilia
•Abnormal protein loss (protein losing enteropathy, nephrotic syndrome)
•Anemia that would preclude phlebotomy for laboratory studies according to standard practice at the site
•Acute serious bacterial infection within 3 months prior to screening
+14 more criteria

Locations (18)

University of California, Irvine

Irvine, California, United States

IMMUNOe International Research Centers

Centennial, Colorado, United States

Allergy Associates of the Palm Beaches

North Palm Beach, Florida, United States

Emory University

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Family Allergy and Asthma Research Institute

Louisville, Kentucky, United States

Children's Hospital New Orleans- LSUHSC School of Medicine

New Orleans, Louisiana, United States

Midwest Immunology Clinical and Infusion Center

Plymouth, Minnesota, United States

SSM Cardinal Glennon Children's Medical Center

St Louis, Missouri, United States

Montefiore Medical Center Division of Allergy/Immunology

The Bronx, New York, United States

Key Dates

Start Date

January 28, 2013

Primary Completion Date

March 13, 2015

Completion Date

March 13, 2015

Last Updated

July 20, 2021

Enrollment

ACTUAL participants

Conditions

Primary Immunodeficiency Diseases (PID)

Interventions

Immune Globulin Intravenous (Human), 10% Solution

BIOLOGICAL

Immune Globulin Subcutaneous (Human), 20% Solution

DRUG

A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases

NCT05755035

Primary Immunodeficiency Diseases (PID)

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COMPLETEDPHASE3

Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID

NCT01175213

Primary Immunodeficiency Diseases (PID)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 20, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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