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Global registry tracks safety of growth drug in kids

NCT ID NCT00903110

Knowledge-focused Sponsor: Esteve Pharmaceuticals, S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 global registry follows 500 children and teens with severe primary IGF-1 deficiency who are taking or will take Increlex® (mecasermin). The goal is to monitor long-term safety and side effects over at least 5 years after treatment ends. It is an observational study, meaning no new drug is being tested—just real-world data collection.

What this could mean

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

Active substance
mecasermin (Increlex®)
What this could lead to
If successful, this registry will provide crucial safety data on long-term use of Increlex® in children, helping doctors better manage treatment.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results depend on real-world reporting and may not apply to all patients.

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.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2008

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Children and adolescents with Growth Failure due to Severe Primary IGF-1 Deficiency

Ages

2 to 18 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: * For US : patients starting or planning to start or currently receiving treatment with Increlex® therapy for severe primary IGF-1 deficiency as defined by the US Increlex® prescribing information or for growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.For EU : patients starting or planning to start or currently receiving treatment with Increlex® therapy according to the locally approved product information. * Parents or legally authorized representatives if applicable must give signed informed consent before any registry-related activities are conducted. Assent from the subject should also be obtained as appropriate Exclusion Criteria: * Subject currently participating in an Increlex® clinical trial * Subject currently participating in any clinical trial for growth retardation * Patient with any contraindication to Increlex® or any condition subject to special warning as per the locally approved label * For US patients, these include patients with hypersensitivity to the active substance or any of the excipients, patients with active or suspected neoplasia and patients with closed epiphyses. * For EU patients: these include patients with hypersensitivity to the active substance or any of the excipients, patients with active or suspected neoplasia or any condition or medical history which increases the risk of benign or malignant neoplasia and patients with closed epiphyses

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Conditions

The condition(s) this trial relates to.

growth delay due to insulin-like growth factor type 1 deficiency

As listed by the trial registrant

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

IGF1 deficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    45 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria II

    NOT_YET_RECRUITING

    Naples, 80138, Italy

  • Azienda Ospedaliera-Universitaria di Parma

    NOT_YET_RECRUITING

    Parma, Italy

  • Azienda USL-IRCCS

    RECRUITING

    Reggio Emilia, Italy

  • Azienda ospedaliera universitaria Meyer

    NOT_YET_RECRUITING

    Florence, 50139, Italy

  • Birmingham Children's Hospital

    TERMINATED

    Birmingham, B4 6NH, United Kingdom

  • CHU Lenval

    WITHDRAWN

    Nice, 06200, France

  • Centre Hospitalier de Blois

    RECRUITING

    Blois, 41000, France

  • Children's Health Specialty Center West Plano

    WITHDRAWN

    Plano, Texas, 75093, United States

  • Children's Hospital of Orange County

    RECRUITING

    Orange, California, 92868, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • D&H National Research Centers

    WITHDRAWN

    Miami, Florida, 33155, United States

  • Diabetologia Pediatrica Azienda Ospedaliero-Universitaria

    NOT_YET_RECRUITING

    Ancona, Italy

  • GHR Mulhouse Sud-Alsace

    TERMINATED

    Mulhouse, France

  • Great Ormond Street Hospital

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • Hospital Parc Taulí de Sabadell

    RECRUITING

    Barcelona, 08208, Spain

  • Hospital Sant Joan de Déu

    RECRUITING

    Barcelona, 08950, Spain

  • Hospital Univ Vall d'Hebrón

    TERMINATED

    Barcelona, 08035, Spain

  • Hospital Univ. de Cruces

    RECRUITING

    Bilbao, 48903, Spain

  • Hospital Universitari Sant Joan de Reus

    RECRUITING

    Reus, 43204, Spain

  • Hospital Universitario y Politécnico La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hôpital Amiens-Picardie

    TERMINATED

    Amiens, 80080, France

  • Hôpital Arnaud de Villeneuve

    RECRUITING

    Montpellier, 34090, France

  • Hôpital Estaing

    RECRUITING

    Clermont-Ferrand, 63100, France

  • Hôpital Femme Mère-Enfant

    RECRUITING

    Bron, 69500, France

  • Hôpital Jean Verdier

    RECRUITING

    Bondy, 93140, France

  • Hôpital Kremlin Bicetre

    RECRUITING

    Paris, 97270, France

  • Hôpital Necker Enfants Malades

    RECRUITING

    Paris, 75015, France

  • Hôpital Pierre Zobda Quitman

    RECRUITING

    Fort-de-France, 97200, Martinique

  • Hôpital Timone Enfants

    RECRUITING

    Marseille, 13005, France

  • Hôpital de Cayenne

    WITHDRAWN

    Cayenne, 97306, French Guiana

  • Hôpital des Enfants

    RECRUITING

    Toulouse, 31300, France

  • I.R.C.C.S. Giannina Gaslini

    RECRUITING

    Genova, 16147, Italy

  • Karolinska Universitetssjukhuset

    RECRUITING

    Stockholm, 17176, Sweden

  • Kliniczny Szpital Wojewódzki

    RECRUITING

    Rzeszów, 35-301, Poland

  • Klinikum Oldenburg

    TERMINATED

    Oldenburg, 26133, Germany

  • Klinikum der Otto von Guericke Universität

    TERMINATED

    Magdeburg, 39120, Germany

  • Leeds General Infirmary

    RECRUITING

    Leeds, LS1 3EX, United Kingdom

  • Linköping University Hospital

    RECRUITING

    Linköping, 57850, Sweden

  • Ospedale Pediatrico Bambino Gesù

    RECRUITING

    Roma, 00165, Italy

  • Ospedale di Bolzano

    RECRUITING

    Bolzano, 39100, Italy

  • Pole medical Bel'Air

    RECRUITING

    Mulhouse, France

  • Pomeranian Medical University

    RECRUITING

    Szczecin, Poland

  • Royal Belfast Hospital for Sick Children

    RECRUITING

    Belfast, BT12 6BA, United Kingdom

  • Royal Manchester Children's Hospital

    TERMINATED

    Manchester, M13 0JH, United Kingdom

  • Salzkammergut-Klinik Vöcklabruck

    RECRUITING

    Vöcklabruck, A-4840, Austria

  • Samodzielny Publiczny Dzieciecy Szpital Kliniczny

    RECRUITING

    Bialystok, 15-274, Poland

  • Spedali Civili di Brescia

    TERMINATED

    Brescia, 25100, Italy

  • Szpital kliniczny im. Karola Jonschnera

    RECRUITING

    Poznan, 60-572, Poland

  • The Royal London Hospital

    RECRUITING

    London, E1 1FR, United Kingdom

  • U.O. Pediatria e Neonatologia Ospedale di Macerata

    TERMINATED

    Province of Macerata, Italy

  • UT Southwestern Medical Center

    NOT_YET_RECRUITING

    Dallas, Texas, 75390, United States

  • University Of Miami Leonard M. Miller

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Miami Leonard M Miller

    RECRUITING

    Miami, Florida, 33136, United States

  • Universitätskliniken des Saarlandes Kinderklinik

    RECRUITING

    Homburg, 66424, Germany

  • Universitätsklinikum Erlangen Kinder- und Jugendklinik

    RECRUITING

    Erlangen, 91054, Germany

  • Universitätsklinikum Heidelberg Kinderheilkunde

    RECRUITING

    Heidelberg, 69120, Germany

  • Uniwersytecki Szpital Dziecięcy w Lublinie

    RECRUITING

    Lublin, 20-093, Poland

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80-294, Poland