Drugs / Fendrix
Fendrix
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Fendrix | — | 2005-02-02 | europa.eu ↗ |
Trials 5 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00805389 | Dec 2008 → Sep 2010 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03410953 | Apr 2018 → Oct 2019 | acute hepatitis B virus infection | Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT03459521 | Sep 2017 → Aug 2021 | hepatitis B virus infection | Corporacion Parc Tauli | Completed | No outcome recorded |
| — | NCT04515368 | Jun 2016 → Sep 2020 | — | Imperial College London | Completed | No outcome recorded |
| — | NCT02032160 | May 2014 → Feb 2016 | hepatitis B virus infection | University of Surrey | Completed | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02434848 Comparator | Jul 2015 → Jun 2022 | HIV infectious disease, hepatitis B virus infection | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT01195246 Comparator | Dec 2010 → Feb 2012 | end stage renal failure | Dynavax Technologies Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00445185 Comparator | Mar 2007 → Jul 2009 | hepatitis B virus infection | Henogen | Completed | No outcome recorded |
| Phase 3 | NCT00291941 Comparator | Feb 2006 → Mar 2007 | hepatitis B virus infection | Henogen | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02368327 Comparator | Feb → Jul 2015 | — | University of Surrey | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fendrix | “Fendrix (Hepatitis B surface antigen adjuvanted by AS04C containing 3¬≠O¬≠desacyl¬≠4'¬≠ monophosphoryl lipid A adsorbed on aluminium phosphate, GlaxoSmithKline; 0.5 mL....” NCT04515368 ↗ |
| Known as | Fendrix vaccine | “Biological: Fendrix vaccine” NCT00445185 ↗ |
| Known as | HB-AS04 | “four doses of FENDrix™ (HB-AS04), an adjuvanted HBV vaccine licensed in Europe for use in this population” PMID 21892006 ↗ Sep 2011 |
| Modality | Vaccine | “Fendrix™ vaccine” NCT00805389 ↗ |
| Route | Intramuscular | “Intramuscular (IM) injection on Day 1” NCT01195246 ↗ |