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Can metformin or hydroxyurea cut transfusions for thalassemia patients?

NCT ID NCT06606886

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 4 trial tested two drugs—hydroxyurea and metformin—in 96 people with transfusion-dependent beta-thalassemia. Participants took one of the two drugs for a year. Researchers measured changes in fetal hemoglobin levels and how often blood transfusions were needed. The goal was to see if either drug could reduce transfusion dependence and improve quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hydroxyurea and metformin
What this could lead to
If successful, this could show that metformin or hydroxyurea reduces the need for blood transfusions in people with beta-thalassemia, potentially improving quality of life.
What could go wrong
This is a small, single-center trial with 96 participants. Results may not apply to all patients, and side effects from these drugs can occur. The study is completed but findings are not yet widely confirmed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

96 people

The number who actually took part.

Started

Sep 2024

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 25 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosed cases of beta-thalassemia major * Transfusion dependent patients and on iron chelating agents * Males and females 10 to 25 years of age * Creatinine ≤1.4 mg/dL * Written informed consent from the patients and up to 18 years consent from the Parents/Guardians. Exclusion Criteria: * Failure to meet inclusion criteria * Refusal to participate * Creatinine \>1.4mg/dL * Liver function tests (ALT and conjugated bilirubin) \> 4 times upper limits of normal * Massive splenomegaly \& Liver fibrosis * Patient on growth hormone * Sickle beta thalassemia * Severe osteoporosis * Hepatitis B \& C * HIV

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Bahria University Health Sciences Campus

    Karachi, Sindh, Pakistan

More trials for these conditions

Other studies related to the condition(s) this trial covers.