AFGBM1
Antisecretory Factor, Administered as an Enriched Egg Powder, Salovum®, as Supplementary Therapy for Primary Glioblastoma During Concomitant Radio-chemotherapy.
Sponsor study identifier
interventional
8
1 country
1
Study Start
September 1, 2019
Actual (reported)Primary Completion
March 31, 2021
Actual (reported)Study Completion
March 31, 2021
Actual (reported)This is a non-randomised, open-label, single center-centre, Phase I-II study in patients with newly diagnosed glioblastoma. 5 patients with newly diagnosed glioblastoma are enrolled in the study and will receive an egg powder enriched for antisecretory factor (AF), Salovum, daily from 2 days before concomitant radio-chemo therapy until 14 days after finalisation.The primary aim of the study is to asses safety and feasibility of this regimen.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2019
Actual (reported)September 26, 2019
Actual (reported)October 4, 2019
Actual (reported)March 31, 2021
Actual (reported)March 31, 2021
Actual (reported)Number of participants with treatment-related adverse
Treatment related adverse events as assessed by CTCAE v 5.0
Cumulative from day 1 to 80
Number of participants with completion of prescribed Salovum treatment
Defined as completing prescribed full Salovum treatment
Cumulative from day 1 to 80
Number of participants with altered blood levels of triglycerides and cholesterol
Change from baseline at day 20, 57 and 70.
Number of participants with reduced or no steroid intake
Change from baseline at day 7, 14, 21, 28, 35, 42, 49, 56, 63 and 70.
Number of participants with detetable blood levels antisecretory factor
Change from baseline at day 20, 57 and 70.
Number of participants with altered blood levels of inflammatory cytokines
Change from baseline at day 20, 57 and 70.
Cognitive function
Change from baseline at day 20, 57 and 70.
Number of participants with decreased neurological function
Change from baseline at day 20, 57 and 70.
Number of participants with decreased performance
Change from baseline at day 20, 57 and 70.
Salovum®, an egg powder enriched for anti secretory factor.
Egg yolk powder enriched for anti secretory factor
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Neurosurgery
Lund, 22185, Sweden
Ehinger E, Kopecky J, Darabi A, Visse E, Edvardsson C, Tomasevic G, Cederberg D, Belting M, Bengzon J, Siesjo P. Antisecretory factor is safe to use as add-on treatment in newly diagnosed glioblastoma. BMC Neurol. 2023 Feb 18;23(1):76. doi: 10.1186/s12883-023-03119-4.
Peter Siesjö, MD, PhD
Skane University Hospital
8 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2019
First Posted
October 4, 2019
Study Start
September 1, 2019
Actual (reported)Anti-secretory Factor as a Treatment for Adults With Severe Traumatic Head Injury
Contact the study team to confirm eligibility.
Primary Completion
March 31, 2021
Actual (reported)Study Completion
March 31, 2021
Actual (reported)Last Updated
April 28, 2021
Record last verified: 2020-11
As there are only 5 patients in this study individual patient data without age and gender will be shared after publication
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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