NCT01985373

Brief Summary

Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous group of immune related disorders both as immune-replacement and immune-modulating therapy. Sanquin developed a 100 mg/ml IVIg product (Nanogam 100 mg/ml). Patient will receive one infusion with Nanogam 50 mg/ml as they used to (same dose) and subsequently 4 infusions with Nanogam 100 mg/ml (same dose). Aim is to show bioequivalency between the 50 mg/ml and the 100 mg/ml product of Sanquin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

October 31, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

October 31, 2013

Last Update Submit

April 3, 2015

Conditions

Primary Immunodeficiency

Keywords

intravenous immunoglobulinpharmacokinetics10% IVIG

Outcome Measures

Primary Outcomes (8)

  • IgG trough levels

    Comparison IVIG 5% and 10%

    before infusion

  • plasma concentration-time curve

    Comparison IVIG 5% and 10%

    predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

  • half-life

    Comparison IVIG 5% and 10%

    predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

  • area under the curve

    Comparison IVIG 5% and 10%

    predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

  • volume of distribution

    Comparison IVIG 5% and 10%

    predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

  • Cmax

    Comparison IVIG 5% and 10%

    predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

  • Tmax

    Comparison IVIG 5% and 10%

    predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

  • elimination rate constant(s)

    Comparison IVIG 5% and 10%

    predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

Secondary Outcomes (1)

  • Adverse Events

    from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency)

Study Arms (1)

Intravenous immunoglobulin infusion

EXPERIMENTAL

One intravenous infusion with Nanogam 50 mg/ml and 4 with Nanogam 100 mg/ml (0.2-0.8 g/kg)

Drug: Intravenous immunoglobulin infusion

Interventions

Intravenous immunoglobulin infusionDRUG

Blood samples are drawn before infusion with Nanogam 50 and Nanogam 100 mg/ml and IgG levels are determined to study PK

Also known as: Nanogam
Intravenous immunoglobulin infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary a- or hypogammaglobulinemia, particularly patients with XLA or CVID
  • Stabilised on treatment with Nanogam 50 mg/ml with 2-4 weeks intervals in an hospital or at home and willing to be treated with 1 infusion of Nanogam 50 mg/ml and 4 infusions of Nanogam 100 mg/ml at the hospital
  • A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose and frequency)
  • Age \>= 18 years
  • The patient has signed the consent form

You may not qualify if:

  • Known with allergic reactions against human plasma or plasma products
  • Having an ongoing progressive disease, including HIV infection
  • Pregnancy or lactation
  • Known with insufficiency of coronary or cerebral circulation
  • Having renal insufficiency (plasma creatinin \> 115µmol/L)
  • Having IgA deficiency and anti-IgA antibodies have been detected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

UMCG

Groningen, Netherlands

Location

LUMC

Leiden, Netherlands

Location

UMC St. Radboud

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

  • F P Kroon, PhD, MD

    LUMC

    PRINCIPAL INVESTIGATOR

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

October 31, 2013

First Posted

November 15, 2013

Study Start

December 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations

NL(4)