Drugs / rhBSSL
rhBSSL
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT00743483 | Aug 2008 → Jun 2009 | cystic fibrosis, exocrine pancreatic insufficiency | Swedish Orphan Biovitrum | Completed | Missed primary |
| Phase 2 | NCT00659243 | Mar 2008 → Feb 2010 | — | Swedish Orphan Biovitrum | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT01413581 | May 2011 → Jul 2013 | fetal growth restriction | Swedish Orphan Biovitrum | Terminated | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT00658905 Comparator | Apr 2008 → May 2009 | — | Swedish Orphan Biovitrum | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2010-05-06 | Sobi, Inc. | Results Swedish Orphan Biovitrum presents first positive Kiobrina® clinical phase II data sobi.com ↗
Swedish Orphan Biovitrum (STO: BVT) today presents as a poster clinical phase II results from the first study showing that Kiobrina® added to infant formula significantly improve growth of preterm infants as compared to placebo after 1 week of treatment. |
| 2010-04-21 | Sobi, Inc. | Results Swedish Orphan Biovitrum has decided to move Kiobrina® into phase III development sobi.com ↗
The combined results of the two clinical studies showed a statistically significant increase (p < 0.001) in growth velocity, which is a medically relevant parameter. |
| 2009-11-25 | Sobi, Inc. | Results Kiobrina(TM) shows positive phase II results in preterm infants sobi.com ↗
The results show statistically significant improvement in the growth velocity in preterm infants when Kiobrina(TM) was added to infant formula compared to placebo. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2010-05-06 | Sobi, Inc. | Swedish Orphan Biovitrum presents first positive Kiobrina® clinical phase II data sobi.com ↗ |
| 2010-04-21 | Sobi, Inc. | Swedish Orphan Biovitrum has decided to move Kiobrina® into phase III development sobi.com ↗ |
| 2009-11-25 | Sobi, Inc. | Kiobrina(TM) shows positive phase II results in preterm infants sobi.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rhBSSL | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00743483 ↗ |
| Known as | recombinant human bile-salt-stimulated lipase | “rhBSSL (recombinant human bile-salt-stimulated lipase)” NCT01413581 ↗ |
| Known as | recombinant human BSSL | “This study evaluated if recombinant human BSSL (rhBSSL) improves growth in preterm infants when added to formula or pasteurized breast milk.” PMID 27244221 ↗ May 2016 |
| Action | Restore | “Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants” NCT00658905 ↗ |
| Modality | Protein / enzyme biologic | “recombinant human BSSL (rhBSSL) treatment” PMID 25222806 ↗ Jul 2014 |
| Route | Oral | “oral suspension” NCT00743483 ↗ |