Drugs / Bemiparin
Bemiparin
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00863577 | Mar 2009 → Dec 2010 | — | Rovi Pharmaceuticals Laboratories | Completed | No outcome recorded |
| Phase 1 | NCT00413088 | Mar 2006 → Feb 2011 | impaired renal function disease | Rovi Pharmaceuticals Laboratories | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT04420299 | Jun 2020 → Jun 2021 | COVID-19 | HM Hospitales | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00369096 | Sep 2006 → Nov 2008 | — | Fundación Renal Iñigo Alvarez De Toledo | Completed | No outcome recorded |
| Phase 2 | NCT00324558 | Jun 2005 → Feb 2010 | small cell carcinoma | Clinica Universidad de Navarra, Universidad de Navarra | Terminated | Met primary Stop: Enrollment |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00399425 | Jun 2001 → Apr 2004 | diabetic peripheral angiopathy, ulcer of lower limbs | Spanish National Health System | Terminated | No outcome recorded |
| Phase 38 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT04604327 | Oct 2020 → May 2021 | COVID-19 | Clinica Universidad de Navarra, Universidad de Navarra | Unknown | Missed primary |
| Phase 3 | NCT03324139 | Jan 2018 → Apr 2022 | fetal growth restriction | Fundació Sant Joan de Déu | Completed | No outcome recorded |
| Phase 3 | NCT02802605 | May 2016 → Jun 2017 | cirrhosis of liver | Marqués de Valdecilla Research Institute (IDIVAL) | Unknown | No outcome recorded |
| Phase 3 | NCT01880216 | Jun 2013 → Jan 2015 | venous thromboembolism | Berlin-Chemie Menarini | Completed | Met primary |
| Phase 3 | NCT00448903 | Mar 2007 → Dec 2009 | chronic ulcer of skin | Rovi Pharmaceuticals Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT00484822 | Feb 2007 → May 2009 | — | Sant Pau Research Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00311896 | Jul 2005 → Feb 2009 | cancer, thrombotic disease | Clinica Universidad de Navarra, Universidad de Navarra | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00219973 | May 2005 → Apr 2009 | cancer, venous thromboembolism | Rovi Pharmaceuticals Laboratories | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02607319 | Nov 2015 → Jul 2022 | infertility disorder | American University of Beirut Medical Center | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02795065 | Mar 2014 → Mar 2016 | venous thromboembolism | Mohamed Sayed Mohamed Abbas | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 0 | NCT03601338 Comparator | Aug 2015 → Dec 2018 | pregnancy disorder with abortive outcome | Hawler Medical University | Completed | No outcome recorded |
| Phase 3 | NCT01164046 Comparator | Aug 2010 → Jul 2014 | neoplasm, venous thromboembolism | University Medical Center Groningen | Terminated | No outcome recorded |
| Phase 4 | NCT01727453 Comparator | Dec 2011 → Sep 2015 | — | Sant Pau Research Institute | Completed | No outcome recorded |
| — | NCT05569681 Comparator | Jan 2023 → Sep 2026 overdue | morbid obesity | Hawler Medical University | Recruiting | No outcome recorded |
| — | NCT01630148 Comparator | Jul 2012 → Mar 2014 | pulmonary embolism, venous thromboembolism | Hawler Medical University | Completed | No outcome recorded |
| — | NCT01588171 Comparator | May 2012 → Oct 2013 | venous thromboembolism | Hawler Medical University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2011-10-19 | Rovi Pharmaceuticals Laboratories | Results Results of the final analysis of the ABEL Phase II clinical trial rovi.es ↗
According to the conclusions of the final analysis of the data from a Phase II clinical trial, the addition of Bemiparin improves the clinical results of the standard anti-tumour treatment of patients with small cell lung cancer. |
| 2011-01-14 | Rovi Pharmaceuticals Laboratories | Results Results of the Phase I trial of oral Bemiparin based on the OCAP technology rovi.es ↗
OCAP® technology does not result in the gastrointestinal absorption of Bemiparin when administered orally |
| 2006-06-23 | Lee's Pharmaceutical Limited | Regulatory Approval to initiate a Clinical Trial for Hibor leespharm.com ↗
Lee's Pharmaceutical Holdings Limited (GEM Stock: 8221: Website: www.leespharm.com ) today announced that the application for a clinical study for the HIBOR® (Bemiparin Sodium) has been approved by the SFDA of China. |
All press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-04-14 | Rovi Pharmaceuticals Laboratories | ROVI signs a co-operation agreement for a clinical trial to study the efficacy and safety of bemiparin in patients hospitalised with pneumonia caused by COVID-19 rovi.es ↗ |
| 2015-06-26 | Rovi Pharmaceuticals Laboratories | ROVI will present positive results of Risperidone ISM® and Bemiparin at the 12th EACPT Congress rovi.es ↗ |
| 2011-10-19 | Rovi Pharmaceuticals Laboratories | Results of the final analysis of the ABEL Phase II clinical trial rovi.es ↗ |
| 2011-01-14 | Rovi Pharmaceuticals Laboratories | Results of the Phase I trial of oral Bemiparin based on the OCAP technology rovi.es ↗ |
| 2007-06-25 | Lee's Pharmaceutical Limited | Completed the Pharmacokinetic Study of HIBOR® (Bemiparin Sodium) leespharm.com ↗ |
| 2006-06-23 | Lee's Pharmaceutical Limited | Approval to initiate a Clinical Trial for Hibor leespharm.com ↗ |
| 2005-12-20 | Lee's Pharmaceutical Limited | New Product Launch in Hong Kong – HIBOR® (Bemiparin Sodium) leespharm.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bemiparin | “Group 1 (low molecular weight heparin: bemiparin), which is the study group: after passing the bleeding episode, will receive low molecular weight heparin (bemiparin) in...” NCT01727453 ↗ |
| Known as | Bemiparin sodium | “Bemiparin sodium 3,500 IU anti Xa/0.3 ml solution for injection in pre-filled syringe will be provided for each patient in Bemiparin group; subcutaneously 6 hours after...” NCT01588171 ↗5“A Multinational, Multicentre, Randomized, Open, Parallel Group Study on the Efficacy and Safety of Bemiparin Sodium (LMWH) Compared to Enoxaparin Sodium (LMWH) in the Treatment...” NCT01880216 ↗ “Bemiparin sodium 3,500 IU anti Xa/0.2 ml solution (Hibor; Laboratories Rovi Pharmaceuticals) for injection in pre-filled syringes.” NCT02607319 ↗ “Bemiparin sodium 3,500 IU anti Xa/0.2 ml solution for injection in the pre-filled syringe” NCT05569681 ↗ “3500 international units (IU) anti-factor Xa of bemiparin sodium” PMID 28808360 ↗ Jul 2017 “Drug: Bemiparin sodium” NCT04604327 ↗ |
| Known as | Bemiparina | “Patients included in this study group will receive 3,500 IU / 0.2 ml / day of Bemiparina sc, from inclusion to delivery (estimated median of 5-6 weeks, with a maximum of 13 weeks).” NCT03324139 ↗ |
| Known as | Bemiparina Sodica | “Drug: Bemiparina Sodica” NCT00484822 ↗ |
| Known as | Hibor | “Bemiparin sodium 3,500 IU anti Xa/0.2 ml solution (Hibor; Laboratories Rovi Pharmaceuticals) for injection in pre-filled syringes.” NCT02607319 ↗1“Patients randomized to receive LMWH will receive bemiparina (Hibor) to maintain an a-Xa levels between 0.4-1.0 U / ml.” NCT01727453 ↗ |
| Modality | Other / unclassified | “Bemiparin, a second-generation LMWH” NCT00219973 ↗ |
| Route | Subcutaneous | “The biological effect of the sc. administration of Bemiparin” NCT00219973 ↗ |