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NCT03164915
A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
Phase 3 trial testing LIV-GAMMA SN Inj. in Immune Thrombocytopenia in 37 participants. Completed in 28 September 2018.
3 April 2018
Quick facts
| Lead sponsor | SK Plasma Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 37 |
| Start date | 24 October 2016 |
| Primary completion | 3 April 2018 |
| Estimated completion | 28 September 2018 |
| Sites | 6 locations across South Korea |
Drugs / interventions tested
- LIV-GAMMA SN Inj. — full drug profile →
Conditions studied
- Immune Thrombocytopenia — all drugs for Immune Thrombocytopenia →
Sponsor
SK Plasma Co., Ltd. — full company profile →
Who can join
19 and older, any sex, with Immune Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main purpose of this study is to assess the efficacy and safety of LIV-GAMMA SN Inj. in adult subjects with ITP. The primary objective of this study is to determine the responder rate. A response is defined as a platelet count of ≥30×10\^9/L and at least a 2 fold increase of the baseline, confirmed on at least 2 separate occasions at least 7 days apart without bleeding. The secondary objectives are to evaluate the further efficacy assessments including duration of response, and the safety of LIV-GAMMA SN Inj.
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 NCT03164915
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of LIV-GAMMA SN Inj.
Trials testing the same drug.
- NCT05666453 — A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in ABO-Incompatible Liver Transplantation · Phase 2 · terminated
Other recruiting trials for Immune Thrombocytopenia
Currently open trials in the same condition.
- NCT07104565 — Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Diso · Phase 2 · recruiting
- NCT07007962 — Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed · Phase 3 · recruiting
- NCT07216079 — Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan · Phase 3 · active not recruiting
- NCT06776510 — A Clinical Study of NAD in the Treatment of Immune Thrombocytopenia · Phase 1, PHASE2 · recruiting
- NCT06715215 — Role of Acute Phase Proteins In Diagnosis of Immune Thrombocytopenia · NA · recruiting
Other SK Plasma Co., Ltd. trials
Trials by the same sponsor.
- NCT06738901 — An Open-label Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of SKP-0141 for the Treatment · Phase 3 · not yet recruiting
- NCT05666453 — A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in ABO-Incompatible Liver Transplantation · Phase 2 · terminated
- NCT05566990 — A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj.10% in Primary Immune Thrombocytopenia (ITP) · Phase 3 · completed
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 NCT03164915 (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 SK Plasma Co., Ltd.
- Last refreshed: 30 March 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/NCT03164915.
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