Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04838145
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2019-01-04
Brief Title:
The Diabetes Virus Detection and Intervention Trial
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
The Diabetes Virus Detection and Intervention Trial
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DiViDInt
Brief Summary:
A randomized double-blind placebo-controlled study in 96 children and adolescents age 6-15 newly diagnosed with type 1 diabetes to describe the influence of antiviral treatment Pleconaril and Ribavirin on progression of disease and residual insulin secretion
Detailed Description:
If antiviral treatment is efficient in halting the disease progression it will be to great benefit for the participating patients Maintenance or even an increase in beta cell mass due to regeneration will lead to improved endogenous insulin production and give a milder course of the disease with improved glycemic control This will in a substantial way improve the long-term prognosis with less severe long term vascular complicationsSome patients may have close to complete remission and be able to stop insulin treatment If antiviral treatment is effective it would add proof to the concept that type 1 diabetes in its origin is a viral disease This would be an important milestone in medical research and a breakthrough in the understanding of the etiopathogenesis of autoimmune diseases It may promote the development of vaccines to prevent the disease T1D seems more aggressive in children than in adults and the beta cell function decline rapidly compared to adults As a consequence the effect of antiviral treatment will potentially be more significant in children than in adults Children have higher HbA1c which increases the risk of complications Thus T1D is a more aggressive disease in children than in adults and hence its important to do this study in children Pharmaceuticals are usually studied in different age intervals commonly 1-6 years 6-12 years and 12-15 years For safety reasons and simplicity the investigators want to start with the two older groups The investigators will treat the participants with two antiviral medications Pleconaril and ribavirin or placebo in a double blind randomized placebo controlled parallel group study Pleconaril has previously been given in doses of 5-10mgkg x 2-3 in clinical trials in children thus achieving serum levels high enough for killing the majority of the viruses The investigators have due to the long treatment period reduced the doses to 5 mgkg x 2 Ribavirin will be given in dosages according to Summariy of product characteristics SmPC The investigators have chosen to administer Investigational Medicinal Product IMPs as an oral solution as this will make it easier to give the medication according to weight
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None