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Tirosint®-SOL for Congenital Hypothyroidism

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Congenital HypothyroidismTirosint®-SOL - Drug
Eligibility
1 - 9
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new medication, Tirosint-SOL, to see if it is better than the current treatment for Congenital Hypothyroidism.

Eligible Conditions
  • Congenital Hypothyroidism

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Similar Trials

1
Hypothyroidism QOL questionnaire
1
Accuvein® Veinfinder
1
ACCEL® Absorbable Hemostat Powder

Study Objectives

6 Primary · 4 Secondary · Reporting Duration: Up to 22 months based on age group

Month 22
Adverse events
Signs and symptoms of hyperthyroidism
Signs and symptoms of hypothyroidism
Month 22
Frequency of dose adjustments
Growth patterns for body weight
Growth patterns for head circumference
Growth patterns for length of body
Hormonal (TFTs) profile for FT4
Hormonal (TFTs) profile for TSH
Hormonal (TFTs) profile for TT4
LT4 dose required to maintain TSH in target range (unit: mcg/kg/day)
Parent/caregiver reports of satisfaction and ease of administration preferences
Therapeutic procedure
Up to 28 days
Time to normalize FT4 in neonates
Time to normalize TSH in neonates

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Hypothyroidism QOL questionnaire
1
Accuvein® Veinfinder
1
ACCEL® Absorbable Hemostat Powder

Trial Design

2 Treatment Groups

Control
1 of 2
Treatment
1 of 2

Active Control

Experimental Treatment

126 Total Participants · 2 Treatment Groups

Primary Treatment: Tirosint®-SOL · No Placebo Group · Phase 4

Treatment
Drug
Experimental Group · 1 Intervention: Tirosint®-SOL · Intervention Types: Drug
Control
Drug
ActiveComparator Group · 1 Intervention: Levothyroxine Sodium · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 22 months based on age group

Who is running the clinical trial?

IBSA Institut Biochimique SALead Sponsor
35 Previous Clinical Trials
10,592 Total Patients Enrolled
CromsourceIndustry Sponsor
15 Previous Clinical Trials
2,249 Total Patients Enrolled
Giuseppe MautoneStudy DirectorIBSA Head of R&D Scientific Affairs
1 Previous Clinical Trials
600 Total Patients Enrolled

Eligibility Criteria

Age 1 - 9 · All Participants · 3 Total Inclusion Criteria

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References

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