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NCT00782106
Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously
Phase 1, PHASE2 trial testing Recombinant human hyaluronidase + immune globulin intravenous in Primary Immunodeficiency Diseases (PID) in 11 participants. Completed in 1 November 2007.
1 November 2007
Quick facts
| Lead sponsor | Baxalta now part of Shire |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 4 December 2006 |
| Primary completion | 1 November 2007 |
| Estimated completion | 1 November 2007 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Recombinant human hyaluronidase + immune globulin intravenous — full drug profile →
- Recombinant human hyaluronidase + immune globulin intravenous — full drug profile →
Conditions studied
- Primary Immunodeficiency Diseases (PID) — all drugs for Primary Immunodeficiency Diseases (PID) →
Sponsor
Baxalta now part of Shire — full company profile →
Who can join
16 and older, any sex, with Primary Immunodeficiency Diseases (PID). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the study is to determine the feasibility of infusing a full 4-week dose of Immune Globulin Intravenous (Human), 10% in a single subcutaneous site and the amount of recombinant human hyaluronidase needed to infuse that dose with no more than mild local adverse drug reactions.
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:
- PubMed search for NCT00782106
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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)
- Trial protocol + status: ClinicalTrials.gov NCT00782106 (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: 5 May 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/NCT00782106.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing