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NCT00162006
Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura
Phase 2 trial testing Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution in Immune Thrombocytopenic Purpura (ITP) in 28 participants. Completed in 3 December 2003.
3 December 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 | 28 |
| Start date | 13 January 2003 |
| Primary completion | 3 December 2003 |
| Estimated completion | 3 December 2003 |
| Sites | 11 locations across Poland, Germany, Hungary, Czechia |
Drugs / interventions tested
- Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution — full drug profile →
Conditions studied
- Immune Thrombocytopenic Purpura (ITP) — all drugs for Immune Thrombocytopenic Purpura (ITP) →
Sponsor
Baxalta now part of Shire — full company profile →
Who can join
Adults 18 to 65, any sex, with Immune Thrombocytopenic Purpura (ITP). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00162006
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Immune Thrombocytopenic Purpura (ITP)
Currently open trials in the same condition.
- NCT06948318 — A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia · Phase 3 · recruiting
- NCT06722235 — A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia · Phase 3 · 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 NCT00162006 (US National Library of Medicine, public domain)
- 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: 3 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/NCT00162006.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing