Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml

Primary Immunodeficiency Clinical Trial

— Nanogam  

Official title:

Pharmacokinetics and Safety of the Intravenous Human Immunoglobulin Product Nanogam 100 mg/ml

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985373
• Other study ID #: MD2012.02
• Secondary ID: 2012-005727-32
• Status: Completed
• Phase: Phase 3
• First received: October 31, 2013
• Last updated: April 3, 2015
• Start date: December 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Sanquin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immunodeficiency

Intervention

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

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Ziekenhuis	Den Bosch
Netherlands	UMCG	Groningen
Netherlands	LUMC	Leiden
Netherlands	UMC St. Radboud	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Sanquin

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IgG trough levels	Comparison IVIG 5% and 10%	before infusion	No
Primary	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	No
Primary	half-life	Comparison IVIG 5% and 10%	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose	No
Primary	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	No
Primary	volume of distribution	Comparison IVIG 5% and 10%	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose	No
Primary	Cmax	Comparison IVIG 5% and 10%	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose	No
Primary	Tmax	Comparison IVIG 5% and 10%	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose	No
Primary	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	No
Secondary	Adverse Events	number and type	from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency)	Yes