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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-05

Study Completion Date

2024-10-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Growth Hormone Deficiency Growth Hormone Treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transition to long-acting growth hormone (LAGH)

Participants in this arm will transition between daily growth hormone treatment and long-acting growth hormone treatment.

Long-Acting Growth Hormone (LAGH)

Intervention Type DRUG

Long-acting growth hormone (LAGH) treatment

Consistent daily growth hormone (DGH)

Participants in this group will continue with daily growth hormone treatment.

No interventions assigned to this group

Interventions

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Long-Acting Growth Hormone (LAGH)

Long-acting growth hormone (LAGH) treatment

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No