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- | Increlex (mecasermin) / Ipsen
Trial completion: IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency (clinicaltrials.gov) - Feb 28, 2024
P1/2, N=7, Completed, Sponsor: Children's Hospital Medical Center, Cincinnati
Active, not recruiting --> Completed
- | Increlex (mecasermin) / Ipsen
Biomarker, Journal: Frequency and predictive factors of hypoglycemia in patients treated with rhIGF-1: Data from the Eu-IGFD Registry. (Pubmed Central) - Aug 14, 2023
P=N/A
Active, not recruiting --> Completed Hypoglycemia occurs more frequently in patients with prior history of hypoglycemia and/or Laron syndrome compared with patients without these risk factors, and these patients should be carefully monitored for this adverse event throughout treatment.
- Increlex (mecasermin) / Ipsen
Alterations in stem cell populations during rIgF-1 (Increlex) therapy in patients with SPIGF1D (Rome, Italy) - Nov 13, 2022 - Abstract #ESPE2022ESPE_1557;
For the first time we performed long-term observation of these populations in response to rhIGF-1 (mecasermin) therapy...In conclusion, here we provided novel insight into stem cells participation in IGF-1 deficiency in patients. Thus, we demonstrated basis for future studies in context of stem cells and IGF-1 role in growth disturbances.
- Increlex (mecasermin) / Ipsen
Pathway to assess severe primary IGF-1 deficiency diagnosis in a real-life setting: data from the Global Increlex® Registry (Rome, Italy) - Nov 13, 2022 - Abstract #ESPE2022ESPE_1021;
P=N/A
In children reported to have SPIGFD enrolled in the registry, HtSDS and baseline IGF-1 were reported in >90% of patients, while additional biochemical information including GH levels were less frequently reported, indicating that full reporting should be pursued. Recommendations on SPIGFD recognition and diagnosis should be produced and made available to the medical community in order to improve homogeneity in the diagnostic workup of these patients across countries.
- Increlex (mecasermin) / Ipsen
Global Increlex® Registry, post-authorisation surveillance registry monitoring the long-term safety and effectiveness of mecasermin in children and adolescents with Severe Primary IGFD (SPIGFD): objectives and study design (Rome, Italy) - Nov 13, 2022 - Abstract #ESPE2022ESPE_1020;
P=N/A
Recommendations on SPIGFD recognition and diagnosis should be produced and made available to the medical community in order to improve homogeneity in the diagnostic workup of these patients across countries. The registry will allow for characterisation of the risk-benefit profile of mecasermin in patients presenting with SPIGFD in real-life settings.
- | Increlex (mecasermin) / Ipsen
Journal: Alterations in Stem Cell Populations in IGF-1 Deficient Pediatric Patients Subjected to Mecasermin (Increlex) Treatment. (Pubmed Central) - Oct 22, 2022
In conclusion, here we provided novel insight into stem cells participation in IGF-1 deficiency in patients. Thus, we demonstrated basis for future studies in context of stem cells and IGF-1 role in growth disturbances.
- | Increlex (mecasermin) / Ipsen
Trial completion date: IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency (clinicaltrials.gov) - Oct 17, 2022
P1/2, N=7, Active, not recruiting, Sponsor: Children's Hospital Medical Center, Cincinnati
Thus, we demonstrated basis for future studies in context of stem cells and IGF-1 role in growth disturbances. Trial completion date: Nov 2022 --> Jan 2023
- | Increlex (mecasermin) / Ipsen
Trial primary completion date: IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency (clinicaltrials.gov) - Jul 19, 2022
P1/2, N=7, Active, not recruiting, Sponsor: Children's Hospital Medical Center, Cincinnati
Trial completion date: Nov 2022 --> Jan 2023 Trial primary completion date: May 2022 --> Aug 2022
- | Increlex (mecasermin) / Ipsen
Trial completion date, Trial primary completion date: A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder (clinicaltrials.gov) - Jul 5, 2022
P2, N=10, Recruiting, Sponsor: Icahn School of Medicine at Mount Sinai
Trial primary completion date: May 2022 --> Aug 2022 Trial completion date: May 2022 --> Jul 2024 | Trial primary completion date: May 2022 --> Jul 2024
- | Increlex (mecasermin) / Ipsen
Trial completion, Enrollment change: Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome) (clinicaltrials.gov) - May 12, 2022
P2, N=19, Completed, Sponsor: Icahn School of Medicine at Mount Sinai
Trial completion date: May 2022 --> Jul 2024 | Trial primary completion date: May 2022 --> Jul 2024 Recruiting --> Completed | N=35 --> 19
- | Increlex (mecasermin) / Ipsen
Journal: Pubertal Timing and Growth Dynamics in Children With Severe Primary IGF-1 Deficiency: Results From the European Increlex Growth Forum Database Registry. (Pubmed Central) - Apr 23, 2022
P=N/A
Puberty is delayed in untreated children and adolescents with severe primary IGF-1 deficiency (SPIGFD); to date, it has not been reported whether recombinant human insulin-like growth factor-1 mecasermin (rhIGF-1) treatment affects this...Children and adolescents treated with rhIGF-1 for SPIGFD with growth failure experienced an increase in height SDS in prepubertal years compared with baseline. Despite 1.5 years delay in pubertal start and a delayed and slightly lower PPHV, height SDS gain during puberty was maintained.
- | Increlex (mecasermin) / Ipsen
Trial completion date, Trial primary completion date: IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency (clinicaltrials.gov) - Apr 7, 2022
P1/2, N=7, Active, not recruiting, Sponsor: Children's Hospital Medical Center, Cincinnati
Despite 1.5 years delay in pubertal start and a delayed and slightly lower PPHV, height SDS gain during puberty was maintained. Trial completion date: May 2022 --> Sep 2022 | Trial primary completion date: May 2021 --> May 2022
- || Increlex (mecasermin) / Ipsen
Enrollment change, Trial completion date, Trial primary completion date: EuIGFD: Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex (clinicaltrials.gov) - Dec 10, 2021
P=N/A, N=500, Recruiting, Sponsor: Ipsen
Trial completion date: May 2022 --> Sep 2022 | Trial primary completion date: May 2021 --> May 2022 N=330 --> 500 | Trial completion date: Dec 2023 --> Dec 2027 | Trial primary completion date: Dec 2023 --> Dec 2027
- Increlex (mecasermin) / Ipsen
[VIRTUAL] Assessment of genetic defects, baseline characteristics and adverse events reported in the Increlex® registry () - Aug 27, 2021 - Abstract #ESPE2021ESPE_875;
P=N/A
Patients with versus without reported genetic abnormalities had shorter stature at first rhIGF-1 dose and more TEAEs. Further work is required to understand the role of genetic testing in clinical practice.
- | Increlex (mecasermin) / Ipsen
Trial completion date: IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency (clinicaltrials.gov) - Aug 18, 2021
P1/2, N=7, Active, not recruiting, Sponsor: Children's Hospital Medical Center, Cincinnati
Further work is required to understand the role of genetic testing in clinical practice. Trial completion date: Nov 2021 --> May 2022
- | Increlex (mecasermin) / Ipsen
Trial completion date: IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency (clinicaltrials.gov) - May 20, 2021
P1/2, N=7, Active, not recruiting, Sponsor: Children's Hospital Medical Center, Cincinnati
Trial completion date: Nov 2021 --> May 2022 Trial completion date: Aug 2021 --> Nov 2021
- | Increlex (mecasermin) / Ipsen
Trial primary completion date: IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency (clinicaltrials.gov) - May 7, 2021
P1/2, N=7, Active, not recruiting, Sponsor: Children's Hospital Medical Center, Cincinnati
Trial completion date: Aug 2021 --> Nov 2021 Trial primary completion date: Feb 2021 --> Jun 2021
- | Increlex (mecasermin) / Ipsen
Trial completion date, Trial primary completion date: Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome) (clinicaltrials.gov) - Mar 15, 2021
P2, N=35, Recruiting, Sponsor: Icahn School of Medicine at Mount Sinai
Trial primary completion date: Feb 2021 --> Jun 2021 Trial completion date: Apr 2021 --> Apr 2023 | Trial primary completion date: Apr 2021 --> Apr 2023
- | Increlex (mecasermin) / Ipsen
Trial completion date: IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency (clinicaltrials.gov) - Jan 26, 2021
P1/2, N=7, Active, not recruiting, Sponsor: Children's Hospital Medical Center, Cincinnati
Trial completion date: Apr 2021 --> Apr 2023 | Trial primary completion date: Apr 2021 --> Apr 2023 Trial completion date: Dec 2020 --> Jun 2021
- || Increlex (mecasermin) / Ipsen
Trial completion: Safety and Efficacy Study of IGF-1 in Duchenne Muscular Dystrophy (clinicaltrials.gov) - Jan 20, 2021
P1/2, N=44, Completed, Sponsor: Children's Hospital Medical Center, Cincinnati
Trial completion date: Dec 2020 --> Jun 2021 Active, not recruiting --> Completed
- | Increlex (mecasermin) / Ipsen
Trial completion date, Trial primary completion date: A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder (clinicaltrials.gov) - Jan 21, 2020
P2, N=10, Recruiting, Sponsor: Icahn School of Medicine at Mount Sinai
Active, not recruiting --> Completed Trial completion date: Jan 2020 --> May 2022 | Trial primary completion date: Jan 2020 --> May 2022
- | Increlex (mecasermin) / Ipsen
Trial completion: IGF-1 and Bone Loss in Women With Anorexia Nervosa (clinicaltrials.gov) - Jul 16, 2019
P=N/A, N=148, Completed, Sponsor: Massachusetts General Hospital
Trial completion date: Jan 2020 --> May 2022 | Trial primary completion date: Jan 2020 --> May 2022 Active, not recruiting --> Completed
- ||||| Increlex (mecasermin) / Ipsen, Nutropin AQ (somatropin) / Ipsen, Roche
Trial termination, Combination therapy: rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency (clinicaltrials.gov) - Jan 30, 2019
P2, N=106, Terminated, Sponsor: Ipsen
Active, not recruiting --> Completed Completed --> Terminated; The study was prematurely terminated due to strategic reasons.
- | Increlex (mecasermin) / Ipsen
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date: Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome) (clinicaltrials.gov) - Aug 2, 2018
P2, N=35, Recruiting, Sponsor: Icahn School of Medicine at Mount Sinai
Completed --> Terminated; The study was prematurely terminated due to strategic reasons. Completed --> Recruiting | N=20 --> 35 | Trial completion date: Sep 2016 --> Apr 2021 | Trial primary completion date: Sep 2016 --> Apr 2021
- | Increlex (mecasermin) / Ipsen
Enrollment closed, Trial completion date, Trial primary completion date: IGF-1 and Bone Loss in Women With Anorexia Nervosa (clinicaltrials.gov) - Jul 30, 2018
P=N/A, N=148, Active, not recruiting, Sponsor: Massachusetts General Hospital
Completed --> Recruiting | N=20 --> 35 | Trial completion date: Sep 2016 --> Apr 2021 | Trial primary completion date: Sep 2016 --> Apr 2021 Recruiting --> Active, not recruiting | Trial completion date: Oct 2018 --> Mar 2019 | Trial primary completion date: Oct 2018 --> Mar 2019
- | Increlex (mecasermin) / Ipsen
Trial primary completion date: IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency (clinicaltrials.gov) - Jan 29, 2018
P1/2, N=7, Active, not recruiting, Sponsor: Children's Hospital Medical Center, Cincinnati
Recruiting --> Active, not recruiting | Trial completion date: Oct 2018 --> Mar 2019 | Trial primary completion date: Oct 2018 --> Mar 2019 Trial primary completion date: Dec 2016 --> Dec 2020
- | Increlex (mecasermin) / Ipsen
Phase classification: Treatment of Rett Syndrome With rhIGF-1 (Mecasermin [rDNA]Injection) (clinicaltrials.gov) - Jun 22, 2017
P1, N=12, Completed, Sponsor: Boston Children
Trial primary completion date: Dec 2016 --> Dec 2020 Phase classification: P1/2 --> P1
- Increlex (mecasermin) / Ipsen
Trial primary completion date: IGF-1 and Bone Loss in Women With Anorexia Nervosa (clinicaltrials.gov) - Jan 23, 2017
P=N/A, N=200, Recruiting, Sponsor: Massachusetts General Hospital
Phase classification: P1/2 --> P1 Trial primary completion date: Oct 2017 --> Oct 2018
- Increlex (mecasermin) / Ipsen
Trial primary completion date: A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder (clinicaltrials.gov) - Jan 11, 2017
P2, N=10, Recruiting, Sponsor: Icahn School of Medicine at Mount Sinai
Trial primary completion date: Oct 2017 --> Oct 2018 Trial primary completion date: Dec 2016 --> Jan 2020
- Increlex (mecasermin) / Ipsen
Trial completion: Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome) (clinicaltrials.gov) - Jan 11, 2017
P2, N=20, Completed, Sponsor: Icahn School of Medicine at Mount Sinai
Trial primary completion date: Dec 2016 --> Jan 2020 Active, not recruiting --> Completed
- Increlex (mecasermin) / Ipsen
Trial completion, Trial primary completion date: Treatment of Rett Syndrome With Recombinant Human IGF-1 (clinicaltrials.gov) - Dec 1, 2016
P2, N=30, Completed, Sponsor: Boston Children’s Hospital
Active, not recruiting --> Completed Recruiting --> Completed | Trial primary completion date: Mar 2016 --> Jul 2016
- Increlex (mecasermin) / Ipsen
Enrollment closed: IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency (clinicaltrials.gov) - Jul 27, 2016
P1/2, N=7, Active, not recruiting, Sponsor: Children's Hospital Medical Center, Cincinnati
Recruiting --> Completed | Trial primary completion date: Mar 2016 --> Jul 2016 Not yet recruiting --> Active, not recruiting
- Increlex (mecasermin) / Ipsen
Enrollment change, Trial withdrawal, Trial primary completion date: Increlex Treatment of Children With Chronic Liver Disease and Short Stature (clinicaltrials.gov) - Jul 15, 2016
P=N/A, N=0, Withdrawn, Sponsor: University of California, Los Angeles
Not yet recruiting --> Active, not recruiting N=20 --> 0 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jun 2013 --> Oct 2011
- Increlex (mecasermin) / Ipsen
Trial primary completion date: A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder (clinicaltrials.gov) - Mar 17, 2016
P2, N=10, Recruiting, Sponsor: Icahn School of Medicine at Mount Sinai
N=20 --> 0 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jun 2013 --> Oct 2011 Trial primary completion date: Jan 2016 --> Dec 2016
- Increlex (mecasermin) / Ipsen
Trial primary completion date: IGF-1 and Bone Loss in Women With Anorexia Nervosa (clinicaltrials.gov) - Feb 11, 2016
P=N/A, N=200, Recruiting, Sponsor: Massachusetts General Hospital
Trial primary completion date: Jan 2016 --> Dec 2016 Trial primary completion date: Oct 2016 --> Oct 2017
- Increlex (mecasermin) / Ipsen
Enrollment closed, Trial primary completion date: Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome) (clinicaltrials.gov) - Jan 28, 2016
P2, N=20, Active, not recruiting, Sponsor: Icahn School of Medicine at Mount Sinai
Trial primary completion date: Oct 2016 --> Oct 2017 Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2016 --> Sep 2016
- || Increlex (mecasermin) / Ipsen
Enrollment change: EuIGFD: Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex (clinicaltrials.gov) - Dec 23, 2015
P=N/A, N=330, Recruiting, Sponsor: Ipsen
Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2016 --> Sep 2016 N=3000 --> 330
- Increlex (mecasermin) / Ipsen
New P1/2 trial: IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency (clinicaltrials.gov) - Dec 21, 2015
P1/2, N=8, Not yet recruiting, Sponsor: Children's Hospital Medical Center, Cincinnati
- ||||||| Increlex (mecasermin) / Ipsen
Trial completion: Long-Term Treatment With rhIGF-1 in GHIS (clinicaltrials.gov) - Sep 30, 2015
P2/3, N=92, Completed, Sponsor: Ipsen
N=3000 --> 330 Active, not recruiting --> Completed
- Increlex (mecasermin) / Ipsen
Enrollment change, Trial primary completion date: Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome) (clinicaltrials.gov) - Jul 15, 2015
P2, N=18, Recruiting, Sponsor: Icahn School of Medicine at Mount Sinai
Active, not recruiting --> Completed N=10 --> 18 | Trial primary completion date: Mar 2015 --> Jan 2016
- Increlex (mecasermin) / Ipsen
Trial termination: Treatment for Growth Failure in Patients With X-Linked Severe Combined Immunodeficiency: Phase 2 Study of Insulin-Like Growth Factor-1 (clinicaltrials.gov) - Jul 6, 2015
P1/2, N=6, Terminated, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
N=10 --> 18 | Trial primary completion date: Mar 2015 --> Jan 2016 Completed --> Terminated; Insufficient patient participation
- Increlex (mecasermin) / Ipsen
Trial primary completion date: Treatment of Rett Syndrome With Recombinant Human IGF-1 (clinicaltrials.gov) - Jun 11, 2015
P2, N=30, Recruiting, Sponsor: Children's Hospital Boston
Completed --> Terminated; Insufficient patient participation Trial primary completion date: Dec 2015 --> Mar 2016
- Increlex (mecasermin) / Ipsen
Enrollment change, Trial termination: Effect of Increlex (clinicaltrials.gov) - May 16, 2015
P2/3, N=3, Terminated, Sponsor: Nationwide Children's Hospital
Trial primary completion date: Dec 2015 --> Mar 2016 N=20 --> 3 | Recruiting --> Terminated; PI left institution
- Increlex (mecasermin) / Ipsen
Trial termination, Trial primary completion date: IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex (clinicaltrials.gov) - Apr 15, 2015
P=N/A, N=1378, Terminated, Sponsor: Ipsen
N=20 --> 3 | Recruiting --> Terminated; PI left institution Active, not recruiting --> Terminated | Trial primary completion date: Jun 2020 --> May 2014; Shortage of Increlex supply
- Increlex (mecasermin) / Ipsen, Nutropin AQ (somatropin) / Ipsen, Roche
Trial completion: Metabolic Effects of GH and IGF-I in Growth Hormone Deficient(GHD) and Diabetes and Impaired Glucose Tolerance(IGT) (clinicaltrials.gov) - Apr 7, 2015
P3, N=14, Completed, Sponsor: Karolinska University Hospital
Active, not recruiting --> Terminated | Trial primary completion date: Jun 2020 --> May 2014; Shortage of Increlex supply Recruiting --> Completed
- Increlex (mecasermin) / Ipsen
Trial primary completion date: A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder (clinicaltrials.gov) - Mar 7, 2015
P2, N=10, Recruiting, Sponsor: Mount Sinai School of Medicine
Recruiting --> Completed Trial primary completion date: Jan 2015 --> Jan 2016
- || Increlex (mecasermin) / Ipsen
Trial primary completion date: EuIGFD: Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex (clinicaltrials.gov) - Nov 4, 2014
P=N/A, N=3000, Recruiting, Sponsor: Ipsen
Trial primary completion date: Jan 2015 --> Jan 2016 Trial primary completion date: Dec 2099 --> Dec 2023
- Increlex (mecasermin) / Ipsen
Trial primary completion date: Treatment of Rett Syndrome With Recombinant Human IGF-1 (clinicaltrials.gov) - Sep 30, 2014
P2, N=30, Recruiting, Sponsor: Children's Hospital Boston
Trial primary completion date: Dec 2099 --> Dec 2023 Trial primary completion date: Dec 2014 --> Dec 2015
- || Increlex (mecasermin) / Ipsen
Trial initiation date: IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex (clinicaltrials.gov) - May 22, 2014
P=N/A, N=1378, Active, not recruiting, Sponsor: Ipsen
Trial primary completion date: Dec 2014 --> Dec 2015 Initiation date: May 2006 --> Jun 2006
- || Increlex (mecasermin) / Ipsen
Enrollment change: IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex (clinicaltrials.gov) - May 22, 2014
P=N/A, N=250, Active, not recruiting, Sponsor: Ipsen
Initiation date: May 2006 --> Jun 2006 N=2000 --> 250