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NCT00903110 · ClinicalTrials.gov registry record
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).
A clinical trial of IGF1 Deficiency, sponsored by Esteve Pharmaceuticals, S.A..
- Recruiting
- Registry status
- 500
- Enrollment target
- 20
- Study locations
NCT00903110: Recruiting study of IGF1 Deficiency, sponsored by Esteve Pharmaceuticals, S.A..
NCT00903110 is a study of IGF1 Deficiency that is actively recruiting participants, run by Esteve Pharmaceuticals, S.A.. The registered enrollment target is 500 participants. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00903110, a study of IGF1 Deficiency, is actively recruiting participants, sponsored by Esteve Pharmaceuticals, S.A..
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 20
- Study locations
Study 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 children and adolescents receiving Increlex® therapy for SPIGFD according to the locally approved product information.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Increlex®
Study Locations (20)
Other
- Salzkammergut-Klinik Vöcklabruck - Vöcklabruck
- Hôpital Amiens-Picardie - Amiens
- Centre Hospitalier de Blois - Blois
- Hôpital Jean Verdier - Bondy
- Hôpital Femme Mère-Enfant - Bron
- Hôpital Estaing - Clermont-Ferrand
- Hôpital Timone Enfants - Marseille
- Hôpital Arnaud de Villeneuve - Montpellier
- GHR Mulhouse Sud-Alsace - Mulhouse
- Pole medical Bel'Air - Mulhouse
- CHU Lenval - Nice
- Hôpital Necker Enfants Malades - Paris
- Hôpital Kremlin Bicetre - Paris
Florida
- University of Miami Leonard M Miller - Miami
- University Of Miami Leonard M. Miller - Miami
- D&H National Research Centers - Miami
Texas
- UT Southwestern Medical Center - Dallas
- Children's Health Specialty Center West Plano - Plano
California
- Children's Hospital of Orange County - Orange
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2008-12-09 |
| Est. Completion | 2027-12-31 |
What NCT00903110 shows while recruiting
NCT00903110 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with IGF1 Deficiency appearing as the primary indexed condition, and to 1 intervention - of which Increlex® is the first listed.
NCT00903110 names 20 study sites across 5 states, led by Other, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT00903110 about?
NCT00903110 is a clinical study titled "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).". 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 o...
What is the current status of trial NCT00903110?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2008-12-09. Estimated completion is 2027-12-31.
What conditions does trial NCT00903110 study?
This clinical trial studies the following conditions: IGF1 Deficiency.
What interventions are being tested in trial NCT00903110?
The interventions under investigation include: Increlex® (DRUG).
Who is sponsoring clinical trial NCT00903110?
This trial is sponsored by Esteve Pharmaceuticals, S.A., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00903110 being conducted?
This trial has 20 study locations across California, Florida, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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