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Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml

NCT01985373 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2015-04-06

No results posted yet for this study

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.

Conditions

  • Primary Immunodeficiency

Interventions

DRUG

Intravenous immunoglobulin infusion

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

Sponsors & Collaborators

  • Prothya Biosolutions

    lead INDUSTRY

Principal Investigators

  • F P Kroon, PhD, MD · LUMC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01985373 on ClinicalTrials.gov