Clinical trial NCT01458171: Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
Official title: A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Immune Deficiency Disorder
Keywords: Immune globulin subcutaneous
SCIG
Primary immunodeficiency
PID
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 23
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06_002CR (NCT01199705).


Eligibility criteria: Inclusion Criteria:

* Subjects who have participated in study ZLB06_002CR and who have tolerated IgPro20 well.
* Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years at the time of obtaining informed consent), as far as possible.

Exclusion Criteria:

* Ongoing serious bacterial infections (SBIs) (pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of the first infusion.
* Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (known total urine protein concentration \>0.2 g/L or urine protein ++ by dipstick).
* Pregnancy or nursing mother.
* Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for ZLB06_002CR.
* Subjects who are planning to donate blood during the study.
* Re-entry of subjects previously participating in the current follow-up study.
* Known or suspected antibodies to the IMP, or to excipients of the IMP.

Primary outcomes:
measure: Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion
timeFrame: 24 weeks
Secondary outcomes:
measure: Overall Rate of AEs Per Infusion
timeFrame: 24 weeks
measure: Number of Subjects With Newly Developing or Worsening AEs
timeFrame: 24 weeks
measure: Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good'
timeFrame: 24 to 72 hours after infusion
measure: IgG Trough Level
timeFrame: 24 weeks
measure: Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)
timeFrame: 24 weeks
measure: Number of Infection Episodes (Serious and Non-serious)
timeFrame: 24 weeks
measure: Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections.
timeFrame: 24 weeks
measure: Number of Days of Hospitalization Due to Infections.
timeFrame: 24 weeks
measure: Duration of Use of Antibiotics for Infection Prophylaxis and Treatment
timeFrame: 24 weeks
Other outcomes:
measure: Rate of Infection Episodes (Serious and Non-serious)
timeFrame: 24 weeks
Locations:
city: Nagoya city
country: Japan
facility: Study site
state: Aichi Pref.
city: Chiba city
country: Japan
facility: Study site
state: Chiba Pref.
city: Fukuoka city
country: Japan
facility: Study site
state: Fukuoka
city: Gifu city
country: Japan
facility: Study site
state: Gifu Pref.
city: Sapporo city
country: Japan
facility: Study site
state: Hokkaido
city: Moriguchi city
country: Japan
facility: Study site
state: Osaka
city: Koshigaya city
country: Japan
facility: Study site
state: Saitama Pref.
city: Tokorozawa city
country: Japan
facility: Study site
state: Saitama Pref.
city: Bunkyo-ku
country: Japan
facility: Study site
state: Tokyo Metropolitan
Study officials:
affiliation: CSL Behring K.K.
name: Midori Kobayashi
role: STUDY_DIRECTOR
References: