IGF1 DeficiencyNCT00903110
Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).
An observational study of IGF1 Deficiency, run by Esteve Pharmaceuticals, S.A. at 58 sites in 11 countries.
Trial summary
The Increlex® Global Registry is a descriptive, multicenter, observational, prospective, open-ended, non interventional, post-authorisation surveillance registry. The main purpose of this global registry is to collect, analyse and report safety data during and up to at least 5 years after the end of treatment in… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- IGF1 Deficiency
- What is being tested?
- Increlex®
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 58 sitesin 11 countries
- Study dates
- 9 Dec 2008to 31 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents with Growth Failure due to Severe Primary IGF-1 Deficiency
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
58 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
Esteve Global Clinical Development contact
58 sites in 11 countries
France13 sites, 10 recruiting
- Terminated
Hôpital Amiens-Picardie
Amiens, 80080
- Recruiting
Centre Hospitalier de Blois
Blois, 41000
- Recruiting
Hôpital Jean Verdier
Bondy, 93140
- Recruiting
Hôpital Femme Mère-Enfant
Bron, 69500
- Recruiting
Hôpital Estaing
Clermont-Ferrand, 63100
- Recruiting
Hôpital Timone Enfants
Marseille, 13005
- Recruiting
Hôpital Arnaud de Villeneuve
Montpellier, 34090
- Terminated
GHR Mulhouse Sud-Alsace
Mulhouse
- Recruiting
Pole medical Bel'Air
Mulhouse
- Withdrawn
CHU Lenval
Nice, 06200
- Recruiting
Hôpital Necker Enfants Malades
Paris, 75015
- Recruiting
Hôpital Kremlin Bicetre
Paris, 97270
- Recruiting
Hôpital des Enfants
Toulouse, 31300
Italy10 sites, 8 recruiting
- Not yet recruiting
Diabetologia Pediatrica Azienda Ospedaliero-Universitaria
Ancona
- Recruiting
Ospedale di Bolzano
Bolzano, 39100
- Terminated
Spedali Civili di Brescia
Brescia, 25100
- Not yet recruiting
Azienda ospedaliera universitaria Meyer
Florence, 50139
- Recruiting
I.R.C.C.S. Giannina Gaslini
Genova, 16147
- Not yet recruiting
Azienda Ospedaliera Universitaria II
Naples, 80138
- Not yet recruiting
Azienda Ospedaliera-Universitaria di Parma
Parma
- Terminated
U.O. Pediatria e Neonatologia Ospedale di Macerata
Province of Macerata
- Recruiting
Azienda USL-IRCCS
Reggio Emilia
- Recruiting
Ospedale Pediatrico Bambino Gesù
Roma, 00165
United States7 sites, 5 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
- Not yet recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
University of Miami Leonard M Miller
Miami, Florida, 33136
- Recruiting
University Of Miami Leonard M. Miller
Miami, Florida, 33136
- Withdrawn
D&H National Research Centers
Miami, Florida, 33155
- Recruiting
Children's Hospital of Orange County
Orange, California, 92868
- Withdrawn
Children's Health Specialty Center West Plano
Plano, Texas, 75093
Poland6 sites, 6 recruiting
- Recruiting
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Bialystok, 15-274
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-294
- Recruiting
Uniwersytecki Szpital Dziecięcy w Lublinie
Lublin, 20-093
- Recruiting
Szpital kliniczny im. Karola Jonschnera
Poznan, 60-572
- Recruiting
Kliniczny Szpital Wojewódzki
Rzeszów, 35-301
- Recruiting
Pomeranian Medical University
Szczecin
Spain6 sites, 5 recruiting
- Terminated
Hospital Univ Vall d'Hebrón
Barcelona, 08035
- Recruiting
Hospital Parc Taulí de Sabadell
Barcelona, 08208
- Recruiting
Hospital Sant Joan de Déu
Barcelona, 08950
- Recruiting
Hospital Univ. de Cruces
Bilbao, 48903
- Recruiting
Hospital Universitari Sant Joan de Reus
Reus, 43204
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, 46026
United Kingdom6 sites, 4 recruiting
- Recruiting
Royal Belfast Hospital for Sick Children
Belfast, BT12 6BA
- Terminated
Birmingham Children's Hospital
Birmingham, B4 6NH
- Recruiting
Leeds General Infirmary
Leeds, LS1 3EX
- Recruiting
The Royal London Hospital
London, E1 1FR
- Recruiting
Great Ormond Street Hospital
London, WC1N 3JH
- Terminated
Royal Manchester Children's Hospital
Manchester, M13 0JH
Germany5 sites, 3 recruiting
- Recruiting
Universitätsklinikum Erlangen Kinder- und Jugendklinik
Erlangen, 91054
- Recruiting
Universitätsklinikum Heidelberg Kinderheilkunde
Heidelberg, 69120
- Recruiting
Universitätskliniken des Saarlandes Kinderklinik
Homburg, 66424
- Terminated
Klinikum der Otto von Guericke Universität
Magdeburg, 39120
- Terminated
Klinikum Oldenburg
Oldenburg, 26133
Sweden2 sites, 2 recruiting
- Recruiting
Linköping University Hospital
Linköping, 57850
- Recruiting
Karolinska Universitetssjukhuset
Stockholm, 17176
Austria1 site, 1 recruiting
- Recruiting
Salzkammergut-Klinik Vöcklabruck
Vöcklabruck, A-4840
Martinique1 site, 1 recruiting
- Recruiting
Hôpital Pierre Zobda Quitman
Fort-de-France, 97200
Z
About this study
The Increlex® Global Registry is a descriptive, multicenter, observational, prospective, open-ended, non interventional, post-authorisation surveillance registry.
The main purpose of this global registry is to collect, analyse and report safety data during and up to at least 5 years after the end of treatment in children and adolescents receiving Increlex® therapy for SPIGFD according to the locally approved product information.
Read the detailed description
This registry is a Post-Authorisation Safety Study called the Increlex® Global Registry which is intended primarily to monitor the safety of Increlex® therapy in children and adolescents with Severe Primary IGF-1 Deficiency and secondly to follow the effectiveness of this treatment. Patients who have already started Increlex® therapy before entering this registry may be included and data will be collected retrospectively.
The countries participating in this registry are Austria, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom and the USA
- Conditions
- IGF1 Deficiency
- Being tested
- Increlex®
- Medical subject headings
- Insulin-Like Growth Factor I Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increlex®Drug
Increlex® (mecasermin [rDNA origin] injection), 10 mg/ml solution for injection, 40-120mcg/kg BID or 0,04 to 0,12 mg/kg BID, as prescribed by physician
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SAEs (including AESI of neoplasia) and all AEs, targeted AEs, deaths and withdrawals due to AEs.
Targeted AE includes hypersensitivity; scoliosis; immunogenicity (presence of antibodies if available); slipped capital femoral epiphysis, headache, otitis media, papilloedema, hypoglycaemia (suspected or documented - documented means blood level glucose < 50 mg/dL or 2.78 mmol/L), acromegalic facial changes, gynaecomastia, hearing loss, intracranial hypertension, lipohypertrophy at injection sites, sleep apnoea, tonsillar hypertrophy, cardiomegaly, oedema and myalgia.
Measured: During the treatment period up to 30 days after the last dose.
Secondary outcomes (21)
Incidence of SAEs (including AESI of neoplasia), targeted AEs, all AEs, deaths, withdrawals due to AEs, special situations and concomitant medications
In the overall population, and in the subset of children and adolescents exposed to Increlex® for at least 3 cumulative years excluding interruptions.
Measured: Within 5 years post-treatment
Incidence of special situations and concomitant medications
Measured: During the treatment period an average of 5 years and within 5 years post-treatment
Changes in height Standard Deviation Score (SDS)
Measured: From baseline at least up to 5 years or until the final adult height is achieved.
Height velocity
Measured: From baseline at least up to 5 years or until the final adult height is achieved.
Bone age development
Measured: From baseline at least up to 5 years or until the final adult height is achieved
Body mass index (BMI)
Measured: From baseline at least up to 5 years or until the final adult height is achieved.
Pubertal stage
Measured: From baseline at least up to 5 years or until the final adult height is achieved.
Estimation of differences between predicted adult height (PAH) and final adult height (FAH)
Measured: From baseline at least up to 5 years or until the final adult height is achieved.
Modelisation to identify predictive factors of height SDS change
Measured: From baseline at least up to 5 years or until the final adult height is achieved.
Modelisation to identify predictive factors of Height velocity
Measured: From baseline at least up to 5 years or until the final adult height is achieved
Modelisation to identify predictive factors of FAH
Measured: From baseline at least up to 5 years or until the final adult height is achieved
Modelisation to identify predictive factors of pubertal (Tanner) stage
Measured: From baseline at least up to 5 years or until the final adult height is achieved
Modelisation to identify predictive factors of bone age development
Measured: From baseline at least up to 5 years or until the final adult height is achieved
Dose of Increlex® administrated
Measured: Periodically assessed during the study until treatment stop at least up to 5 years.
Duration of Increlex exposure
Measured: Periodically assessed during the study until treatment stop at least up to 5 years.
Description of effectiveness parameters height SDS according to average dose received and according to dose ranges (e.g. 4 dose ranges (≤50, ]50-80], ]80-110], > 110 μg/kg BID)).
This analysis will support the description of the lowest effective dose
Measured: Periodically assessed during the study until treatment stop at least up to 5 years.
Description of effectiveness parameters height velocity according to average dose received and according to dose ranges (e.g. 4 dose ranges (≤50, ]50-80], ]80-110], > 110 μg/kg BID)).
This analysis will support the description of the lowest effective dose
Measured: Periodically assessed during the study until treatment stop at least up to 5 years.
Biological assessment : baseline GH concentrations, IGF-1 levels, IGFBP-3 levels and binding proteins.
Measured: Throughout study at least up to 5 years.
Presence or absence of gene deletion/mutation
including: GH gene, IGF-1 gene, FGF, PTPN11, GHR, D3-GHR, STAT5b, ALS, SHOX, PAPPA2 and any other genetic tests performed.
Measured: Throughout study at least up to 5 years.
Changes in QoL assessment using EQ-5D in participant aged 4 and over.
The QoL will be assessed using the EQ-5D-Y paediatric questionnaire. The 5 domains and VAS will be described at each timepoint as well as the evolution from baseline.
Measured: At baseline, at year one, at least up to 5 years, at Final Adult Height.
Description of neoplasia (benign and malignant) and hypoglycaemia
Measured: Within the first 3 years after treatment start, between 3 and 5 years and over 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study start9 Dec 2008
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for IGF1 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Esteve Pharmaceuticals, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Program Clinical Lead, Study director, Esteve
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903110
- Sponsor's protocol ID
- 2-79-52800-002
- Other IDs
- EUPAS7708
- Status last verified
- Feb 2026
- First submitted
- 30 Apr 2009
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ramon-Krauel M, Polak M, Maghnie M, Woelfle J, Sert C, Perrot V, Bang P. Near-Adult Height Outcomes in Patients Treated With rhIGF-1 for Severe Growth Failure: Real-World IGFD Registry Data. J Clin Endocrinol Metab. 2026 Jan 21;111(2):e500-e511. doi: 10.1210/clinem/dgaf390.
PubMed 40626687Bang P, Polak M, Bossowski A, Maghnie M, Argente J, Ramon-Krauel M, Sert C, Perrot V, Mazain S, Woelfle J. Frequency and Predictive Factors of Hypoglycemia in Patients Treated With rhIGF-1: Data From the Eu-IGFD Registry. J Clin Endocrinol Metab. 2023 Dec 21;109(1):46-56. doi: 10.1210/clinem/dgad479.
PubMed 37579214Bang P, Polak M, Perrot V, Sert C, Shaikh H, Woelfle J. Pubertal Timing and Growth Dynamics in Children With Severe Primary IGF-1 Deficiency: Results From the European Increlex(R) Growth Forum Database Registry. Front Endocrinol (Lausanne). 2022 Feb 18;13:812568. doi: 10.3389/fendo.2022.812568. eCollection 2022.
PubMed 35250870Bang P, Woelfle J, Perrot V, Sert C, Polak M. Effectiveness and safety of rhIGF1 therapy in patients with or without Laron syndrome. Eur J Endocrinol. 2021 Feb;184(2):267-276. doi: 10.1530/EJE-20-0325.
PubMed 33434161
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).
- ClinicalTrials.gov ID
- NCT00903110
- Acronym / sponsor ID
- 2-79-52800-002
- Conditions
- IGF1 Deficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Esteve Pharmaceuticals, S.A.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2008 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Increlex® Global Registry is a descriptive, multicenter, observational, prospective, open-ended, non interventional, post-authorisation surveillance registry.
The main purpose of this global registry is to collect, analyse and report safety data during and up to at least 5 years after the end of treatment in children and adolescents receiving Increlex® therapy for SPIGFD according to the locally approved product information.
Detailed description
This registry is a Post-Authorisation Safety Study called the Increlex® Global Registry which is intended primarily to monitor the safety of Increlex® therapy in children and adolescents with Severe Primary IGF-1 Deficiency and secondly to follow the effectiveness of this treatment. Patients who have already started Increlex® therapy before entering this registry may be included and data will be collected retrospectively.
The countries participating in this registry are Austria, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom and the USA
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents with Growth Failure due to Severe Primary IGF-1 Deficiency
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increlex®Increlex® (mecasermin [rDNA origin] injection), 10 mg/ml solution for injection, 40-120mcg/kg BID or 0,04 to 0,12 mg/kg BID, as prescribed by physician | Drug | – |
Primary outcome
Incidence of SAEs (including AESI of neoplasia) and all AEs, targeted AEs, deaths and withdrawals due to AEs.
Time frame: During the treatment period up to 30 days after the last dose.
Targeted AE includes hypersensitivity; scoliosis; immunogenicity (presence of antibodies if available); slipped capital femoral epiphysis, headache, otitis media, papilloedema, hypoglycaemia (suspected or documented - documented means blood level glucose < 50 mg/dL or 2.78 mmol/L), acromegalic facial changes, gynaecomastia, hearing loss, intracranial hypertension, lipohypertrophy at injection sites, sleep apnoea, tonsillar hypertrophy, cardiomegaly, oedema and myalgia.
21 secondary outcomes
Incidence of SAEs (including AESI of neoplasia), targeted AEs, all AEs, deaths, withdrawals due to AEs, special situations and concomitant medications
Time frame: Within 5 years post-treatment
Incidence of special situations and concomitant medications
Time frame: During the treatment period an average of 5 years and within 5 years post-treatment
Changes in height Standard Deviation Score (SDS)
Time frame: From baseline at least up to 5 years or until the final adult height is achieved.
Height velocity
Time frame: From baseline at least up to 5 years or until the final adult height is achieved.
Bone age development
Time frame: From baseline at least up to 5 years or until the final adult height is achieved
Body mass index (BMI)
Time frame: From baseline at least up to 5 years or until the final adult height is achieved.
Pubertal stage
Time frame: From baseline at least up to 5 years or until the final adult height is achieved.
Estimation of differences between predicted adult height (PAH) and final adult height (FAH)
Time frame: From baseline at least up to 5 years or until the final adult height is achieved.
Modelisation to identify predictive factors of height SDS change
Time frame: From baseline at least up to 5 years or until the final adult height is achieved.
Modelisation to identify predictive factors of Height velocity
Time frame: From baseline at least up to 5 years or until the final adult height is achieved
Modelisation to identify predictive factors of FAH
Time frame: From baseline at least up to 5 years or until the final adult height is achieved
Modelisation to identify predictive factors of pubertal (Tanner) stage
Time frame: From baseline at least up to 5 years or until the final adult height is achieved
Modelisation to identify predictive factors of bone age development
Time frame: From baseline at least up to 5 years or until the final adult height is achieved
Dose of Increlex® administrated
Time frame: Periodically assessed during the study until treatment stop at least up to 5 years.
Duration of Increlex exposure
Time frame: Periodically assessed during the study until treatment stop at least up to 5 years.
Description of effectiveness parameters height SDS according to average dose received and according to dose ranges (e.g. 4 dose ranges (≤50, ]50-80], ]80-110], > 110 μg/kg BID)).
Time frame: Periodically assessed during the study until treatment stop at least up to 5 years.
Description of effectiveness parameters height velocity according to average dose received and according to dose ranges (e.g. 4 dose ranges (≤50, ]50-80], ]80-110], > 110 μg/kg BID)).
Time frame: Periodically assessed during the study until treatment stop at least up to 5 years.
Biological assessment : baseline GH concentrations, IGF-1 levels, IGFBP-3 levels and binding proteins.
Time frame: Throughout study at least up to 5 years.
Presence or absence of gene deletion/mutation
Time frame: Throughout study at least up to 5 years.
Changes in QoL assessment using EQ-5D in participant aged 4 and over.
Time frame: At baseline, at year one, at least up to 5 years, at Final Adult Height.
Description of neoplasia (benign and malignant) and hypoglycaemia
Time frame: Within the first 3 years after treatment start, between 3 and 5 years and over 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 40626687Ramon-Krauel M, Polak M, Maghnie M, Woelfle J, Sert C, Perrot V, Bang P. Near-Adult Height Outcomes in Patients Treated With rhIGF-1 for Severe Growth Failure: Real-World IGFD Registry Data. J Clin Endocrinol Metab. 2026 Jan 21;111(2):e500-e511. doi: 10.1210/clinem/dgaf390.
- Derived from this study: PubMed 37579214Bang P, Polak M, Bossowski A, Maghnie M, Argente J, Ramon-Krauel M, Sert C, Perrot V, Mazain S, Woelfle J. Frequency and Predictive Factors of Hypoglycemia in Patients Treated With rhIGF-1: Data From the Eu-IGFD Registry. J Clin Endocrinol Metab. 2023 Dec 21;109(1):46-56. doi: 10.1210/clinem/dgad479.
- Derived from this study: PubMed 35250870Bang P, Polak M, Perrot V, Sert C, Shaikh H, Woelfle J. Pubertal Timing and Growth Dynamics in Children With Severe Primary IGF-1 Deficiency: Results From the European Increlex(R) Growth Forum Database Registry. Front Endocrinol (Lausanne). 2022 Feb 18;13:812568. doi: 10.3389/fendo.2022.812568. eCollection 2022.
- Derived from this study: PubMed 33434161Bang P, Woelfle J, Perrot V, Sert C, Polak M. Effectiveness and safety of rhIGF1 therapy in patients with or without Laron syndrome. Eur J Endocrinol. 2021 Feb;184(2):267-276. doi: 10.1530/EJE-20-0325.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esteve Global Clinical Development contact
Global Program Clinical Lead study director
Esteve
58 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IGF1 Deficiency, run by Esteve Pharmaceuticals, S.A. at 58 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in France, Italy, United States, Poland, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esteve Global Clinical Development (increlexregistry@esteve.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of SAEs (including AESI of neoplasia) and all AEs, targeted AEs, deaths and withdrawals due to AEs. (time frame: During the treatment period up to 30 days after the last dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00903110, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.