Who is sponsoring NCT00161993?

NCT00161993 is sponsored by Baxalta now part of Shire.

What condition does NCT00161993 study?

NCT00161993 studies Primary Immunodeficiency Diseases (PID), Agammaglobulinemia, Hypogammaglobulinemia.

Is NCT00161993 still recruiting?

NCT00161993 is currently completed. Last updated 24 August 2021.

Last reviewed 2021-08-24 · How we verify

NCT00161993

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 24 August 2021

What this trial tests

Phase 2 trial testing Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in Primary Immunodeficiency Diseases (PID) in 24 participants. Completed in 24 September 2003.

Timeline

13 June 2002

Primary endpoint
24 September 2003

24 September 2003

Quick facts

Lead sponsor	Baxalta now part of Shire
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	13 June 2002
Primary completion	24 September 2003
Estimated completion	24 September 2003
Sites	6 locations across Sweden, Finland

Drugs / interventions tested

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

Conditions studied

Primary Immunodeficiency Diseases (PID) — all drugs for Primary Immunodeficiency Diseases (PID) →
Agammaglobulinemia — all drugs for Agammaglobulinemia →
Hypogammaglobulinemia — all drugs for Hypogammaglobulinemia →

Sponsor

Baxalta now part of Shire — full company profile →

Who can join

18 and older, any sex, with Primary Immunodeficiency Diseases (PID) or Agammaglobulinemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effects of Body Mass and Age on the Pharmacokinetics of Subcutaneous or Hyaluronidase-facilitated Subcutaneous Immunoglobulin G in Primary Immunodeficiency Diseases.
Li Z, Follman K, Freshwater E, Engler F, et al · · 2023 · cited 3× · PMID 37773562 · DOI 10.1007/s10875-023-01572-x

Verify or expand the search:

Other recruiting trials for Primary Immunodeficiency Diseases (PID)

Currently open trials in the same condition.

NCT06565078 — A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Prim · recruiting
NCT07261891 — Ex Vivo Evaluation of JAK-inhibitor and Gene Therapeutical Approach in JAK-STAT Related Disorders · NA · recruiting
NCT06076642 — A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases · Phase 3 · active not recruiting
NCT07004803 — Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency · NA · recruiting

Other Baxalta now part of Shire trials

Trials by the same sponsor.

NCT04985682 — A Study of ADVATE in People With Hemophilia A in India · Phase 4 · completed
NCT04578535 — A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) Wi · Phase 1 · completed
NCT04346108 — A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunode · Phase 3 · completed
NCT04158934 — A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A · active not recruiting
NCT04394286 — A Phase 1/2 Study of SHP648, an Adeno-Associated Viral Vector for Gene Transfer in Hemophilia B Subjects · Phase 1, PHASE2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00161993 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Baxalta now part of Shire
Last refreshed: 24 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00161993.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing