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NCT02247141
A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam® Given Via the Subcutaneous Route in Primary Antibody Deficient Patients.
Phase 3 trial testing Subgam® (Human Normal Immunoglobulin Solution) in Primary Antibody Deficiency. Completed.
1 January 2005
Quick facts
| Lead sponsor | Bio Products Laboratory |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Start date | 1 June 2000 |
| Primary completion | 1 January 2005 |
| Sites | 14 locations across United Kingdom |
Drugs / interventions tested
- Subgam® (Human Normal Immunoglobulin Solution) — full drug profile →
Conditions studied
- Primary Antibody Deficiency — all drugs for Primary Antibody Deficiency →
Sponsor
Bio Products Laboratory — full company profile →
Who can join
Eligibility, any sex, with Primary Antibody Deficiency. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Proportion of trough levels at each time point where serum IgG was more than equal to 4 g/L
Time frame: Before each infusion in the first 6 months of the study (approximately 30 infusions)
Sponsor's own description
The primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®) given subcutaneously by weekly infusion to patients with primary antibody deficiency. The secondary objective was to determine the safety of Subgam® given subcutaneously by weekly infusion to patients with primary antibody deficiency.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Experience with Subgam, a Subcutaneously Administered Human Normal Immunoglobulin (ClinicalTrials.gov--NCT02247141).
Dash C, Gascoigne E, Gillanders K, Gooi H. · · 2015 · cited 1× · PMID 26222441 · DOI 10.1371/journal.pone.0131565
Verify or expand the search:
- PubMed search for NCT02247141
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Bio Products Laboratory trials
Trials by the same sponsor.
- NCT03161626 — Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery · completed
- NCT03264157 — Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects · Phase 2, PHASE3 · completed
- NCT01884311 — Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases · Phase 3 · completed
- NCT01811875 — Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A · Phase 4 · 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 NCT02247141 (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 Bio Products Laboratory
- Last refreshed: 23 January 2018
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/NCT02247141.
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