Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)

NCT ID: NCT01199705

Last Updated: 2014-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-11-30

Brief Summary

The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.

Conditions

Primary Immune Deficiency

Keywords

Immune globulin subcutaneous; SCIG; Primary immunodeficiency; PID

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IgPro20

Group Type: EXPERIMENTAL

Immune Globulin Subcutaneous (Human) (SCIG)

Intervention Type: BIOLOGICAL

IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human SCIG. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.

Interventions

Immune Globulin Subcutaneous (Human) (SCIG)

IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human SCIG. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.

Intervention Type: BIOLOGICAL

Other Intervention Names

Hizentra

Eligibility Criteria

Inclusion Criteria

• Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy
• Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for at least 3 doses prior to signing of informed consent
• Written informed consent

Exclusion Criteria

• Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin replacement therapy
• Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening
• Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma
• Allergic or other severe reactions to immunoglobulins or other blood products recorded in the past 3 months or at the time of screening
• Pregnancy or nursing mother
• A positive result at screening on any of the following viral markers: human immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus
• Participation in a study with other investigational product during this study and within 3 months prior to screening
• Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior to screening), or planning to donate blood during the study

• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoriyuki Shiga

Role: STUDY_DIRECTOR

CSL Behring K.K.

Locations

Study site

Nagoya, Aichi Pref., Japan

Study site

Chiba, Chiba Pref., Japan

Study site

Gifu, Gifu Pref., Japan

Study site

Sapporo, Hokkaido, Japan

Study site

Sendai, Miyagi Pref., Japan

Study site

Fukuoka City, Osaka, Japan

Study site

Moriguchi, Osaka, Japan

Study site

Osaka, Osaka, Japan

Study site

Koshigaya, Saitama Pref., Japan

Study site

Tokorozawa, Saitama Pref., Japan

Countries

Japan

References

Igarashi A, Kanegane H, Kobayashi M, Miyawaki T, Tsutani K. Cost-minimization analysis of IgPro20, a subcutaneous immunoglobulin, in Japanese patients with primary immunodeficiency. Clin Ther. 2014 Nov 1;36(11):1616-24. doi: 10.1016/j.clinthera.2014.08.007. Epub 2014 Sep 16.

Reference Type: BACKGROUND

PMID: 25236916 (View on PubMed)

Kanegane H, Imai K, Yamada M, Takada H, Ariga T, Bexon M, Rojavin M, Hu W, Kobayashi M, Lawo JP, Nonoyama S, Hara T, Miyawaki T. Efficacy and safety of IgPro20, a subcutaneous immunoglobulin, in Japanese patients with primary immunodeficiency diseases. J Clin Immunol. 2014 Feb;34(2):204-11. doi: 10.1007/s10875-013-9985-z. Epub 2014 Feb 7.

Reference Type: RESULT

PMID: 24504846 (View on PubMed)

Other Identifiers

U1111-1116-6379

Identifier Type: OTHER

Identifier Source: secondary_id

ZLB06_002CR

Identifier Type: -

Identifier Source: org_study_id