Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy

Learn more about:
Related Clinical Trial
Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy Impact of GH Measurements on GHD Diagnosis Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™ The Impact of the Use of Recombinant Human Growth Hormone on ADHD Characteristics in Children and Adolescents Constructing an Insulin-Like Growth Factor-based Prediction Model Peripheral Metabolic Effects of Somatostatin Chromosome 18 Clinical Research Center The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids. An Observational Study on Treatment Compliance by Children Treated With Growth Hormone A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese Growth Hormone as Add-on Treatment in Severe Fibromyalgia With Low IGF-1 Serum Levels (56 Characters) A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood Safety and Efficacy of Long-term Somatropin Treatment in Adults Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal Muscle Genotropin Study Assessing Use of Injection Pen Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy Treatment of Children With Insufficient Secretion of Growth Hormone Metabolic and QOL Effects of GH Treatment in Patients With TBI and AGHD Anterior Pituitary Hormone Replacement in Traumatic Brain Injury Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA) Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children Inter-Assay Growth Hormone and IGF-I Variability A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy Easypod United States User Trial National Cooperative Growth Study in CKD Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients Practicability and Acceptability of Stylomax® in Children Growth Hormone’s Effect on the Cardiovascular System Exploring Interactions Between Growth Hormone and the Microbiome Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children Phase 1 Safety Study of ALRN-5281 in Healthy Subjects Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients Growth Hormone and Chromosome 18q- and Abnormal Growth An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood Study of TV-1106 in Growth Hormone-Deficient Adults Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates Gene Expression in Monocytes of Growth Hormone Deficient Children Study of Pituitary Size and Function in Familial Dwarfism of Sindh Adipocyte Function and Somtropin Deficiency Sustained Release Formulation of Somatropin (rDNA Origin)for Injection Molecular Basis of the Growth Axis in Short Stature Cardiac and Skeletal Muscle Energy Metabolism in Abnormal Growth Hormone States The Effects of Growth Hormone (GH) on Lipid Depots The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study Effects of Growth Hormone Supplementation to Adults With Growth Hormone Deficient on Metabolism and Adipose Tissue Molecular Phenotype Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing Metabolic Endocrinology and Growth Hormone in Adults Growth Hormone Treatment of Young Growth Hormone-Deficient Adults Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.) rhGH Therapy on Hepatic Drug Metabolism Skeletal Muscle Effects of GH in Boys Assessment of Cardiovascular Risk Markers in Growth Hormone Deficient Patients With Nonsecreting Pituitary Adenomas Adipose Tissue and Serum Inflammation in GH Deficiency Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy

Brief Title

Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy

Official Title

Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy

Brief Summary

      The purpose of the study is to compare quality of life, adherence, insulin resistance, body
      composition and efficacy of long-acting growth hormone (LAGH) to daily growth hormone (DGH)
      in children with growth hormone deficiency (GHD). These objectives will be evaluated every 6
      months for subjects prior to switch from DGH to LAGH, and 6 months after.
    

Detailed Description

      Daily subcutaneous injections of recombinant human growth hormone (GH) is the standard of
      care therapy for children with GH deficiency (GHD). A potential impediment to long-term
      efficacy of daily GH (DGH) is a lack of adherence and persistence. Multiple Long-Acting
      Growth Hormone (LAGH) molecules are being developed with the expectation that reduced
      frequency of injections will improve the patient and caregiver experience leading to improved
      adherence and, ultimately, improve efficacy. However, the connection between reduced
      injection frequency, improved adherence and improved efficacy have not yet been demonstrated.
      GH has metabolic effects that impact insulin resistance, body composition and lipid levels.
      There is concern that persistently elevated levels of GH provided by LAGH may have a negative
      effect on metabolism. There is also concern that the larger size of the LAGH molecules in
      development may limit their access to the target tissues leading to an imbalance of the
      linear growth and metabolic effects. The purpose of the study is to compare quality of life,
      adherence, insulin resistance, body composition and efficacy of long-acting growth hormone
      (LAGH) to daily growth hormone (DGH) in children with growth hormone deficiency (GHD). These
      objectives will be evaluated every 6 months for subjects prior to switch from DGH to LAGH,
      and 6 months after.
    


Study Type

Observational


Primary Outcome

Change in Insulin Resistance

Secondary Outcome

 Change in PedsQL Questionnaire

Condition

Growth Hormone Deficiency

Intervention

Long-Acting Growth Hormone (LAGH)

Study Arms / Comparison Groups

 Transition to long-acting growth hormone (LAGH)
Description:  Participants in this arm will transition between daily growth hormone treatment and long-acting growth hormone treatment.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

80

Start Date

August 5, 2021

Completion Date

June 2023

Primary Completion Date

June 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Girls must be between the ages of 2 and 11 years, and boys must be between the ages of
             2 and 13 years

          -  Have established diagnosis of pediatric growth hormone deficiency (GHD). For the
             purposes of the study, GHD is defined as peak growth hormone response to
             clonidine/arginine stimulation testing of <10 ng/mL

          -  Either treatment-naive or currently treated with a daily growth hormone as approved by
             health insurance

        Exclusion Criteria:

          -  Any medical condition which, in the opinion of the Investigator, can be an independent
             cause of short stature and/or limit the response to exogenous growth factor treatment

          -  Current treatment with long-acting growth hormone

          -  Currently pregnant or breastfeeding
      

Gender

All

Ages

2 Years - 13 Years

Accepts Healthy Volunteers

No

Contacts

Bradley S Miller, MD, PhD, (612)-624-5409, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04938466

Organization ID

PEDS-2020-28945


Responsible Party

Sponsor

Study Sponsor

University of Minnesota


Study Sponsor

Bradley S Miller, MD, PhD, Principal Investigator, University of Minnesota Department of Pediatric Endocrinology


Verification Date

September 2021