Safety, Pharmacokinetic and Efficacy Study of a 10% Tripl... | NCT00161993

Studies
Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)

NCT00161993

Sponsor

Baxalta now part of Shire

Status

Completed

Last Update Posted

Aug 24, 2021Actual

Enrollment

24Actual

Phase

Phase 2

Conditions

Primary Immunodeficiency Diseases (PID)
Agammaglobulinemia
Hypogammaglobulinemia

Interventions

Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution
Gammagard S/D (Solvent/Detergent)

Countries

Finland
Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 13, 2002Actual

Primary Completion Date

Sep 24, 2003Actual

Completion Date

Sep 24, 2003Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2021

Last Update Posted Date

Aug 24, 2021Actual

Description Module

Brief Summary

The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Subjects are treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects receive GAMMAGARD S/D to ensure a steady-state and to acquire data with a licensed product; for the remaining 9 infusions subjects receive IGIV, 10% TVR Solution.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics: Trough levels of total immunoglobulin G (IgG) after treatment with Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (IGIV, 10% TVR Solution)		21 days after each infusion (i.e., before the next infusion) of the study drug and at the last visit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects will be eligible for study entry if they:

are at least 18 years old
have a form of primary immunodeficiency (PID) as described by Rosen et al, 1999 16 manifesting as agammaglobulinemia (X-linked) or hypogamma-globulinemia (common variable immunodeficiency), requiring immunoglobulin replacement therapy
have had regular treatment for at least three months with either intravenous immunoglobulin preparations or immunoglobulin preparations for intramuscular use given subcutaneously
have serum IgG levels greater than or equal to 5 g/L as determined by the local laboratory at screening
if female of childbearing potential, agree to employ adequate birth control measures during the study
have given written informed consent

Exclusion Criteria:

Subjects will not be eligible for study entry if they:

had severe adverse reactions to treatment with immunoglobulin preparations during the last three treatments before inclusion into the study
suffer from documented selective IgA deficiency with antibodies against IgA
have an acute infection that requires intravenous antibiotic treatment (Last treatment day should be seven days before study entry.)
are known to be infected with HIV, HCV, or HBV
are at high risk of contracting blood-borne viral infections through parenteral drug abuse or life style
suffer from congestive heart failure and receive on-demand treatment with furosemide
show renal dysfunction defined as serum creatinine greater than or equal to 1.5 mg/dL at baseline visit
received another investigational drug in the three weeks preceding study entry
in case of females, are pregnant or nursing mothers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution	Drug
Gammagard S/D (Solvent/Detergent)	Drug

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital		Tampere		33 521	Finland
Turku University Central Hospital

ID	Term
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

ID	Term
D005719	gamma-Globulins
D012996	Solutions
D012997	Solvents
D003902	Detergents

ID	Term
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D004364	Pharmaceutical Preparations
D020313	Specialty Uses of Chemicals
D020164	Chemical Actions and Uses
D013501	Surface-Active Agents
D006795	Household Products
D013676	Technology, Industry, and Agriculture

ID	Term
D000081207	Primary Immunodeficiency Diseases
D000361	Agammaglobulinemia