Status:
COMPLETED
The Diabetes Virus Detection and Intervention Trial
Lead Sponsor:
Oslo University Hospital
Conditions:
Type1 Diabetes Mellitus
Enterovirus
Eligibility:
All Genders
6-15 years
Phase:
PHASE2
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 Ribav...
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 regeneratio...
Eligibility Criteria
Inclusion
- Diagnosed type 1 Diabetes (E10.9). First injection of insulin maximum three weeks prior to inclusion.
- Must be willing and capable of taking the study drugs and meet for tests and follow up as described.
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization Good Clinical Practice (ICH GCP), and national/local regulations.
- Aged 6.00-15.99 years at inclusion
Exclusion
- Treatment with any oral or injected anti-diabetic medications other than insulin.
- A history of haemolytic anaemia or significantly abnormal haematology results at screening.
- History of severe cardiac disease previous six months.
- Impaired renal function
- Patients taking ethinyl estradiol
- Participation in other clinical trials with a new chemical entity within the previous 3 months.
- Inability or unwillingness to comply with the provisions of this protocol
- Females who are lactating or pregnant.
- Males or females (after menarche) not willing to use highly effective contraception (progesterone-only hormonal anticonception with inhibition of ovulation or sexual abstinence) and barrier contraception (condoms), if sexually active during the treatment period and in the following 7 months
- Presence of serious disease or condition, which in the opinion of the investigator makes the patient non-eligible for the study.
Key Trial Info
Start Date :
August 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2020
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04838145
Start Date
August 30 2018
End Date
October 25 2020
Last Update
April 8 2021
Active Locations (1)
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1
Pediatric department, Oslo University Hospital
Oslo, Norway, 0514