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Growth hormone study for short kids halted early

NCT ID NCT00597480

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at two ways of giving growth hormone to short children who were born small for their age. The goal was to see which dosing method works better for growth and has fewer side effects on metabolism. Only 10 children took part before the study was stopped early.

What this could mean

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

Active substance
recombinant growth hormone (rhGH)
What this could lead to
If successful, this study could help identify the best dosing strategy to improve height while minimizing metabolic risks like insulin resistance.
What could go wrong
This was a small, terminated Phase 4 trial with only 10 participants, so results may not be reliable or generalizable. Growth hormone can increase insulin levels, raising concerns about future diabetes risk.

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

10 people

The number who actually took part.

Start date

Jan 2008

Finished

Jan 2012

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

4 to 10 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: * Prepubertal age * Prepubertal characteristics * Non GH deficient * Short children (height \< -2.5 SDS) * Born SGA (birth height \< -2 SDS) * Parental height adjusted (\< -1 DS) * No rhGH treatment before inclusion Exclusion Criteria: * ALLERY to rhGH or excipients * Small height etiologies * Cancer or cancer treatment ongoing * Drugs interference with growth * Mental impairment * Hypertrophic cardiopathy impairment * Hypertension not under controlled * Intra cranial hypertension not controlled * Diabetes and hyperglycaemia without diabetes * Dyslipidemia * Hepatitis * Kidney failure * Chromosomic aberration and/or genetic disorders (except Silver Russel Syndrome) * No social security * State of health in worst conditions after cardiac surgery, polytraumatism

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Conditions

The condition(s) this trial relates to.

fetal growth restriction Insulin Resistance metabolic syndrome X

As listed by the trial registrant

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

Small for gestational age

Contacts and locations

Locations

  • Hopital Saint Vincent de Paul

    Paris, 75014, France

More trials for these conditions

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