NCT00719680

Brief Summary

The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

4 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

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

January 25, 2013

Completed
Last Updated

April 2, 2014

Status Verified

December 1, 2012

Enrollment Period

2 years

First QC Date

July 21, 2008

Results QC Date

November 27, 2012

Last Update Submit

March 5, 2014

Conditions

Primary Immune Deficiency

Keywords

CVIDXLA

Outcome Measures

Primary Outcomes (2)

  • Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population)

    The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.

    For the duration of the study, up to approximately 104 weeks

  • Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population)

    The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.

    For the duration of the study, up to approximately 104 weeks

Secondary Outcomes (15)

  • Annualized Rate of Any Infection

    For the duration of the study, up to approximately 104 weeks

  • Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations

    Before infusion at Weeks 1, 24, 48, 72, and 96

  • Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection

    For the duration of the study, up to approximately 104 weeks

  • Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection

    For the duration of the study, up to approximately 104 weeks

  • Number of Days of Hospitalization Due to Infection

    For the duration of the study, up to approximately 104 weeks

  • +10 more secondary outcomes

Study Arms (1)

IgPro20

EXPERIMENTAL

The IgPro20 dose will be the same as in the previous pivotal study ZLB04\_009CR (NCT00419341) infused subcutaneously weekly or twice a week (in the latter case, half of a weekly dose will be used)

Biological: IgPro20

Interventions

IgPro20BIOLOGICAL
Also known as: IgG with Proline
IgPro20

Eligibility Criteria

Age2 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with primary humoral immunodeficiency who have participated in the study ZLB04\_009CR (NCT00419341), namely with a diagnosis of Common Variable Immunodeficiency (CVID) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or X-linked Agammaglobulinemia (XLA) as defined by PAGID and ESID
  • Women of childbearing potential must be using and agree to continue using medically approved contraception and must have a negative pregnancy test at screening
  • Written informed consent

You may not qualify if:

  • Ongoing serious bacterial infection at the time of screening
  • Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma, and immunodeficiency with thymoma
  • Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration \> 0.2 g/L)
  • Other significant medical conditions that could increase the risk to the patient
  • Females who are pregnant, breast-feeding or planning a pregnancy during the course of the study
  • A positive result at screening on any of the following viral markers: Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis B virus (HBV)
  • Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration \> 2.5 times Upper Normal Limit (UNL) at Completion Visit of study ZLB04\_009CR (NCT00419341)
  • Creatinine concentration \> 1.5 times UNL at Completion Visit of study ZLB04\_009CR (NCT00419341)
  • Participation in a study with an investigational product other than IgPro20 within 3 months prior to enrollment
  • Evidence of uncooperative attitude
  • Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
  • Subjects who are employees at the investigational site, relatives or spouse of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Contact CSL Behring for facility details

Centennial, Colorado, 80112, United States

Location

Contact CSL Behring for facility details

North Palm Beach, Florida, 33408, United States

Location

Contact CSL Behring for facility details

Indianapolis, Indiana, 46202, United States

Location

Contact CSL Behring for facility details

Dallas, Texas, 75230, United States

Location

Related Publications (1)

  • Jolles S, Borte M, Nelson RP Jr, Rojavin M, Bexon M, Lawo JP, Wasserman RL. Long-term efficacy, safety, and tolerability of Hizentra(R) for treatment of primary immunodeficiency disease. Clin Immunol. 2014 Feb;150(2):161-9. doi: 10.1016/j.clim.2013.10.008. Epub 2013 Oct 26.

    PMID: 24412910RESULT

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

HizentraImmunoglobulin GProline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsImino AcidsAmino Acids, CyclicAmino Acids

Results Point of Contact

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

Study Officials

  • Program Director

    CSL Behring

    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

July 21, 2008

First Posted

July 22, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 2, 2014

Results First Posted

January 25, 2013

Record last verified: 2012-12

Locations

US(4)