Last reviewed · How we verify
NCT02520570
Post-market Safety Reassessment of Ulinastatin for Injection
trial testing ulinastatin in Adverse Reaction to Drug in 10,000 participants. Status unknown.
1 June 2018
Quick facts
| Lead sponsor | Techpool Bio-Pharma Co., Ltd. |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 10,000 |
| Start date | 1 August 2014 |
| Primary completion | 1 June 2018 |
| Estimated completion | 1 August 2018 |
| Sites | 1 location across China |
Drugs / interventions tested
- ulinastatin — full drug profile →
Conditions studied
- Adverse Reaction to Drug — all drugs for Adverse Reaction to Drug →
Sponsor
Techpool Bio-Pharma Co., Ltd. — full company profile →
Who can join
Eligibility, any sex, with Adverse Reaction to Drug. 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.
-
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: participants will be followed for the duration of using ulinastatin, an expected average of 7 days
Sponsor's own description
1. Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc ) 2. Analysis the incidence of adverse drug reactions /adverse events of ulinastatin, collect the main clinical manifestations, treatment, outcome, influence factors; provide evidence for improving the recommended medication plan of ulinastatin. 3. Evaluate the safety of ulinastatin , obtain scientific conclusion , and provide evidence for appropriate medication to administration department of health authority.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02520570
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ulinastatin
Trials testing the same drug.
- NCT04990752 — Effects of Ulinastatin on Inflammatory Response During ECMO Support · unknown
- NCT07090278 — Ulinastatin Treatment Reduces the Incidence of Sepsis-associated Encephalopathy · completed
- NCT03154814 — Ulinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass · Phase 4 · 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 NCT02520570 (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 Techpool Bio-Pharma Co., Ltd.
- Last refreshed: 19 April 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/NCT02520570.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing