WHO ICTRP trial
To study the effect of Octafibrin (i.e. human plasma fibrinogen concentrate…
CTRI/2015/07/005953 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2015/07/005953 |
|---|---|
| Public title | To study the effect of Octafibrin (i.e. human plasma fibrinogen concentrate, which is a product derived from blood) in paediatric subjects with congenital fibrinogen deficiency (a rare bleeding disorder). |
| Scientific title | Prospective, open-label, uncontrolled, phase III study to assess the efficacy, safety, and pharmacokinetics of Octafibrin for on-demand treatment of acute bleeding and to prevent bleeding during and after surgery in paediatric subjects with congenital fibrinogen deficiency. |
| Primary sponsor | Octapharma AG |
| Secondary sponsors | JSS Medical Research India Private Limited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | India;Lebanon;United States of America |
| Conditions | Health Condition 1: D682- Hereditary deficiency of other clotting factors |
| Interventions | Intervention1: Octafibrin (a highly purified, lyophilised, human plasma fibrinogen concentrate, without added albumins): Dosage form: Freeze dried powder with active ingredient to be reconstituted with 50 ml water for injection (WFI) Dose… |
| Registration date | Feb 7, 2015 |
| Target size | 6 |
| Secondary IDs | FORMA-04, Version 4.0 dated 30 May 2017 |
| Registry page | ctri.nic.in |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: