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Taurine Supplementation for Cardiomyopathy in Thalassemia (TICATS Trial)

N/A
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of transfusion-dependent Thalassemia being followed at the RBC clinic at TGH
Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

TICATS Trial Summary

This trial evaluates if adding taurine to standard iron chelation therapy is better at reducing iron overload, oxidative stress & cardiac damage in β-Thalassemia patients.

Who is the study for?
This trial is for adults over 18 with transfusion-dependent Thalassemia, a specific heart condition (LVEF >50%), and certain levels of iron in the heart and liver. It's not for those with recent other trials, high liver iron, low serum ferritin, frequent transfusions or potential pregnancy.Check my eligibility
What is being tested?
The study tests if Taurine added to standard iron removal treatment works better than the treatment alone in reducing heart damage from too much iron in patients with β-Thalassemia. Participants are randomly assigned to get either Taurine or a placebo alongside their usual therapy.See study design
What are the potential side effects?
Potential side effects aren't specified here but could include reactions related to Taurine supplementation such as nausea or digestive issues. Standard chelation therapy side effects may also occur.

TICATS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have transfusion-dependent Thalassemia and am being treated at the RBC clinic at TGH.
Select...
I am 18 years old or older.

TICATS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cardiac iron overload
Secondary outcome measures
Blood taurine level
C-reactive protein
Interleukin-6
+3 more

TICATS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TaurineExperimental Treatment1 Intervention
675mg taurine four times daily
Group II: PlaceboPlacebo Group1 Intervention
placebo four times daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Taurine
2010
Completed Phase 4
~310

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
485,120 Total Patients Enrolled
2 Trials studying Thalassemia
92 Patients Enrolled for Thalassemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this experiment still open?

"Clinicaltrials.gov has noted that this research project is presently recruiting participants, having first been advertised on June 1st 2020 and last updated September 30th 2023."

Answered by AI

What is the upper limit of individuals involved in this experiment?

"Affirmative. The clinical trial is actively looking for willing participants, with the initial post made on June 1st 2020 and an amendment posted September 30th 2021. Consequently, 60 individuals need to be enrolled at one particular medical centre."

Answered by AI
~7 spots leftby Oct 2024