Trial · NCT03874013

Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency

NCT03874013, Phase 3, Completed, OPKO Health, Inc.; results first posted 2021-08-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency. Trials, record NCT03874013. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03874013

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency
NCT number: NCT03874013
Status: Completed
Phases: Phase 3
Enrollment: 44 participants, actual
Lead sponsor: OPKO Health, Inc.
Conditions: Growth Hormone Deficiency
Interventions: MOD-4023, Genotropin
First posted: 2019-03-14
Last updated: 2021-08-12
Results first posted: 2021-08-12

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Annual Height Velocity (HV) After 12 Months	12 months	Annual Height Velocity in cm/year after 12 months of treatment.
Secondary	Height Velocity at 6 Months	6 months	Annualized height velocity (cm/year) for the MOD-4023 and the daily hGH treatment groups
Secondary	Change in Height Standard Deviation Score (SDS) Compared to Baseline After 12 Months	12 months	Change in height standard deviation score (SDS) for the MOD-4023 and the daily hGH treatment groups Height Standard Deviation Score (SDS) is the number of standard deviations above or below the mean height for age and sex. Height in cm is converted to height standard deviation score (SDS) by subtracting the mean and dividing by the SD. A higher Height Standard Deviation Score (SDS) indicates a better outcome
Secondary	Change in Bone Maturation (BM) After 12 Months	12 months	Change in bone maturation (bone age / chronological age) with the method of TW2 using a central bone age reader.
Other	Biochemical	Baseline, Visit 6 (Month 3), Visit 7 (Month 6), Visit 8 (Month 9) and Visit 9 (12 months)	IGF-1 Standard Deviation Score on day 4(-1) after MOD-4023 dosing across study visits (window only applies to visits 6 to 9) Height Standard Deviation Score (SDS) is the number of standard deviations above or below the mean height for age and sex. Height in cm is converted to height standard deviation score (SDS) by subtracting the mean and dividing by the SD. A higher Height Standard Deviation Score (SDS) indicates a better outcome

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Annual Height Velocity (HV) After 12 Months	12 months	One subject in the Genotropin arm did not finish the 12 month period and therefore not included in primary outcome.	cm/year	MEAN
SECONDARY	Height Velocity at 6 Months	6 months	One subject in the Genotropin arm was discontinued from treatment before the 6 month period and therefore not included in secondary outcome.	cm/year	MEAN
SECONDARY	Change in Height Standard Deviation Score (SDS) Compared to Baseline After 12 Months	12 months	One subject in the Genotropin arm did not finish the 12 month period and therefore not included in secondary outcome.	Standard Deviation Score (SDS)	MEAN
SECONDARY	Change in Bone Maturation (BM) After 12 Months	12 months	One subject in the Genotropin arm did not finish the 12 month period and therefore not included in secondary outcome.	ratio of bone age to chronologic age	MEAN
OTHER_PRE_SPECIFIED	Biochemical	Baseline, Visit 6 (Month 3), Visit 7 (Month 6), Visit 8 (Month 9) and Visit 9 (12 months)	One subject in the Genotropin group dropped out due to AE, so no data for 6 and 9 months.	Standard Deviation Score	MEDIAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Annual Height Velocity (HV) After 12 Months	MOD-4023 Treatment Arm		9.78	Standard Deviation 1.59	cm/year
Annual Height Velocity (HV) After 12 Months	Genotropin Treatment Arm		7.78	Standard Deviation 1.14	cm/year
Height Velocity at 6 Months	MOD-4023 Treatment Arm		10.54	Standard Deviation 2.04	cm/year
Height Velocity at 6 Months	Genotropin Treatment Arm		8.34	Standard Deviation 1.84	cm/year
Change in Height Standard Deviation Score (SDS) Compared to Baseline After 12 Months	MOD-4023 Treatment Arm		0.97	Standard Deviation 0.41	Standard Deviation Score (SDS)
Change in Height Standard Deviation Score (SDS) Compared to Baseline After 12 Months	Genotropin Treatment Arm		0.50	Standard Deviation 0.23	Standard Deviation Score (SDS)
Change in Bone Maturation (BM) After 12 Months	MOD-4023 Treatment Arm		0.05	Standard Deviation 0.06	ratio of bone age to chronologic age
Change in Bone Maturation (BM) After 12 Months	Genotropin Treatment Arm		0.03	Standard Deviation 0.06	ratio of bone age to chronologic age
Biochemical	MOD-4023 Treatment Arm	Baseline	-1.460	Standard Deviation 0.902	Standard Deviation Score
Biochemical	Genotropin Treatment Arm	Baseline	-1.420	Standard Deviation 0.843	Standard Deviation Score

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	MOD-4023 Treatment Arm	22
Overall Study	STARTED	Genotropin Treatment Arm	22
Overall Study	COMPLETED	MOD-4023 Treatment Arm	22
Overall Study	COMPLETED	Genotropin Treatment Arm	21
Overall Study	NOT COMPLETED	MOD-4023 Treatment Arm	0
Overall Study	NOT COMPLETED	Genotropin Treatment Arm	1

Source ClinicalTrials.gov

Adverse events58

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Conjunctivitis allergic	Eye disorders	MOD-4023 Treatment Arm	2	22
other	Conjunctivitis allergic	Eye disorders	Genotropin Treatment Arm	1	22
other	Abdominal pain upper	Gastrointestinal disorders	MOD-4023 Treatment Arm	2	22
other	Abdominal pain upper	Gastrointestinal disorders	Genotropin Treatment Arm	0	22
other	Nausea	Gastrointestinal disorders	MOD-4023 Treatment Arm	2	22
other	Nausea	Gastrointestinal disorders	Genotropin Treatment Arm	0	22
other	Stomatitis	Gastrointestinal disorders	MOD-4023 Treatment Arm	2	22
other	Stomatitis	Gastrointestinal disorders	Genotropin Treatment Arm	0	22
other	Vomiting	Gastrointestinal disorders	MOD-4023 Treatment Arm	3	22
other	Vomiting	Gastrointestinal disorders	Genotropin Treatment Arm	1	22

1 to 10 of 58Source ClinicalTrials.gov

See all 58 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MOD-4023 Treatment Arm	0	22
Total, all-cause mortality	Genotropin Treatment Arm	0	22
Total, other adverse events	MOD-4023 Treatment Arm	22	22
Total, other adverse events	Genotropin Treatment Arm	17	22
Total, serious adverse events	MOD-4023 Treatment Arm	2	22
Total, serious adverse events	Genotropin Treatment Arm	2	22

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41183961	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
MOD-4023 Treatment Arm vs Genotropin Treatment Arm: deaths from any cause	Trial comparisons
MOD-4023 Treatment Arm vs Genotropin Treatment Arm: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03874013

GET https://conductscience.org/api/trials/v1/NCT03874013/events?page=2

API reference For AI assistants