Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in more than 60 countries. This study will evaluate the efficacy, safety and the kinetics of Octagam 10% for replacement therapy in primary immunodeficiency diseases.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Benefit of 5% IVIG for Patients With Primary Immunodeficiency Disorders Who Experience Adverse Events on 10% IVIG Preparations

NCT03339778

Primary Immunodeficiency

COMPLETED

Non-Interventional Study on the Tolerability and Efficacy of IVIG

NCT02303093

Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG

COMPLETED

Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.

NCT00278954

Primary Immunodeficiency Common Variable Hypogammaglobulinemia X-linked Hypogammaglobulinemia +3 more

COMPLETED PHASE3

Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)

NCT01581593

Primary Immunodeficiency Agammaglobulinemia Hypogammaglobulinemia +1 more

COMPLETED PHASE3

A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency

NCT01289847

Primary Immune Deficiency Disorders Common Variable Immunodeficiency X-linked Agammaglobulinemia +2 more

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective of the study is to investigate the safety of Octagam 10% in replacement therapy in PID and to compare the pharmacokinetic profile of Octagam 10% with that of the previously used Octagam 5%.

The secondary objective is to investigate the efficacy of Octagam 10% in replacement therapy in PID by monitoring the rate of occurence of serious bacterial infections, the rate of other infections, the trough (pre-next-dose) levels of total serum IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4), the trough (pre-next-dose) levels of selected antigen specific antibodies, the use of antibiotics, the rate of absence from school/ work, and the number of days in hospital.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immunologic Deficiency Syndromes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Octagam 10%

Group Type EXPERIMENTAL

Octagam 10%

Intervention Type DRUG

300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Octagam 10%

300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Confirmed diagnosis of primary immunodeficiency (acc. WHO)
* Previous treatment with commercial Octagam 5% every 3-4 weeks for at least 6 infusions intervals
* Documented IgG trough levels of the two previous infusions before enrollment with a value of at least 5.5 g/L for both

Exclusion Criteria

* Acute infection requiring intravenous antibiotic treatment within two weeks before screening
* Exposure to blood or any blood product or derivative other than commercially available Octagam 5%, within the past 3 months
* History of hypersensitivity to blood or plasma derived products
* Requirement of any routine premedication for IGIV treatment
* History of congenital impairment of pulmonary function
* Severe liver function impairment
* Severe renal function impairment or predisposition for acute renal failure
* History of autoimmune haemolytic anaemia
* History of diabetes mellitus
* Congestive heart failure NYHA III or IV
* Non-controlled arterial hypertension
* History of DVT or thrombotic complications with IGIV treatment
* Known infection with HIV, HCV or HBV
* Treatment with steroids, immunosuppressive or immunomodulatory drugs
* Planned vaccination during study period
* Pregnant or nursing woman

Minimum Eligible Age

2 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No