NCT01199705

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 20, 2013

Completed
Last Updated

December 12, 2014

Status Verified

March 1, 2013

Enrollment Period

11 months

First QC Date

September 8, 2010

Results QC Date

January 1, 2013

Last Update Submit

November 25, 2014

Conditions

Primary Immune Deficiency

Keywords

Immune globulin subcutaneousSCIGPrimary immunodeficiencyPID

Outcome Measures

Primary Outcomes (1)

  • IgG Trough Level

    Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.

    During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24

Secondary Outcomes (8)

  • Number of Infection Episodes (Serious and Non-serious) by Study Period

    Up to 36 weeks

  • Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population

    Up to 36 weeks

  • Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population

    Up to 36 weeks

  • Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period

    Up to 36 weeks

  • Number of Days of Hospitalization Due to Infections by Study Period

    Up to 36 weeks

  • +3 more secondary outcomes

Other Outcomes (2)

  • Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population

    Up to 36 weeks

  • Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population

    Up to 36 weeks

Study Arms (1)

IgPro20

EXPERIMENTAL
Biological: Immune Globulin Subcutaneous (Human) (SCIG)

Interventions

Immune Globulin Subcutaneous (Human) (SCIG)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.

Also known as: Hizentra
IgPro20

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Study site

Nagoya, Aichi Pref., 466-8560, Japan

Location

Study site

Chiba, Chiba Pref., 260-8677, Japan

Location

Study site

Gifu, Gifu Pref., 501-1194, Japan

Location

Study site

Sapporo, Hokkaido, 060-8648, Japan

Location

Study site

Sendai, Miyagi Pref., 980-8574, Japan

Location

Study site

Fukuoka City, Osaka, 812-8582, Japan

Location

Study site

Moriguchi, Osaka, 570-8507, Japan

Location

Study site

Osaka, Osaka, 534-0021, Japan

Location

Study site

Koshigaya, Saitama Pref., 343-8555, Japan

Location

Study site

Tokorozawa, Saitama Pref., 359-8513, Japan

Location

Related Publications (2)

  • 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.

    PMID: 25236916BACKGROUND

  • 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.

    PMID: 24504846RESULT

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

gamma-GlobulinsHizentra

Condition Hierarchy (Ancestors)

Genetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Clinical Trial Disclosure Manager
Organization
CSL Behring
clinicaltrials@cslbehring.com
Use email contact

Study Officials

  • Yoriyuki Shiga

    CSL Behring K.K.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 13, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2011

Study Completion

November 1, 2011

Last Updated

December 12, 2014

Results First Posted

March 20, 2013

Record last verified: 2013-03

Locations

JP(10)