Growth Hormone DeficiencyPhase 3NCT03874013
Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency
A Phase 3 study testing MOD-4023 and Genotropin in people with Growth Hormone Deficiency, run by OPKO Health, Inc. at 46 sites in Japan.
Trial summary
Treatment of children with growth failure due to growth hormone deficiency (GHD). Primary • To evaluate the efficacy and safety of weekly MOD-4023 administration compared to daily Genotropin® administration in Japanese pre-pubertal children with GHD. Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- MOD-4023 and Genotropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 46 sitesJapan
- Study dates
- 7 Dec 2017to 6 Mar 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pre-pubertal child aged ≥ 3 years old, and not yet 10 years for girls (9 years and 364 days) or not yet 11 years for boys (10 years and 364 days), on the date of ICF signature, with either isolated GHD, or GH insufficiency as part of multiple pituitary hormone deficiency.
- Confirmed diagnosis of GHD by 2 different types of GH provocation tests (standardized on growth foundation data): defined as a peak serum GH level of ≤ 6.0 ng/mL or ≤ 16 ng/mL when conducting GHRP-2 provocation test.
- Prior local laboratory results will be accepted subject to pre-approval by the study medical monitor and if the tests were conducted as specified in the protocol.
- Bone age (BA) is not older than chronological age and should be less than 10 for girls and less than 11 for boys.
- Without prior exposure to any r-hGH therapy.
- Height SD score ≤ -2.0 at screening
Show all 15Show fewer
- Impaired height velocity defined as:
- Annualized height velocity (HV) below the 25th percentile for CA (HV < -0.7 SDS) and gender according to the local primary care provider standard.
- The interval between two height measurements should be at least 6 months, but should not exceed 18 months prior to inclusion.
- BMI must be within ±2 SDS of mean BMI for the chronological age and sex.
- Baseline IGF-1 level of at least 1 SDS below the mean IGF-1 level standardized for age and sex (IGF-1 SDS ≤ -1) according to the central laboratory reference values. A single re-test will be allowed (subject to discussion with the study medical monitor) if all other criteria are met.
- Normal creatinine levels according to common practice reference ranges per age.
- Children with multiple hormonal deficiencies must be on stable replacement therapies (no change in dose) for other hypothalamo-pituitary organ axes for at least 3 months prior to ICF signing
- Normal 46 XX karyotype for girls.
- Willing and able to provide written informed consent of the parent or legal guardian of the patient and written assent from pediatric patients (when applicable based on age and Japan regulation).
Who cannot join
- Children with prior history of leukemia, lymphoma, sarcoma or any other forms of cancer.
- History of radiation therapy or chemotherapy
- Malnourished children defined as BMI < -2 SDS for age and sex
- Children with suspected psychosocial dwarfism by the discretion of the investigator
- Children born small for gestational age (SGA - birth weight and/or birth length < -2 SDS for gestational age)
- Presence of anti-hGH antibodies at screening
Show all 18Show fewer
- Any clinically significant abnormality likely to affect growth or the ability to evaluate growth, such as, but not limited to, chronic diseases like renal insufficiency, spinal cord irradiation, etc.
- Children with diabetes mellitus
- Chromosomal abnormalities including Turner's syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, SHOX (short stature homeobox) mutations/deletions and skeletal dysplasia's, with the exception of septo-optic dysplasia.
- Concomitant administration of other treatments that may have an effect on growth such as anabolic steroids, sex steroids, with the exception of ADHD drugs or hormone replacement therapies (thyroxin, hydrocortisone, desmopressin [DDAVP])
- Children requiring glucocorticoid therapy (e.g. for asthma) that are taking chronically a dose greater than 400 µg/d of inhaled budesonide or equivalent as provided in Appendix J.
- Major medical conditions and/or presence of contraindication to r-hGH treatment.
- Known or suspected HIV-positive patient, or patient with advanced diseases such as AIDS or tuberculosis.
- Drug substance or alcohol abuse.
- Known hypersensitivity to the components of study medication.
- Other causes of short stature such as celiac disease, uncontrolled primary hypothyroidism and rickets.
- The patient and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct.
- Participation in any other clinical trial within 30 days prior to screening and throughout the entire study period (including administration of investigational agent).
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
Japan46 sites
Akita University Hospital
Akita, 010-8543
Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital
Asahikawa, Hokkaido, 078-8211
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, 078-8510
Tokyo Metropolitan Childrens Medical Center
Fuchū, Tokyo, 183-8561
Fukuoka Children's Hospital
Fukuoka, 813-0017
Fukuyama City Hospital
Fukuyama, Hiroshima, 721-8511
Gifu University Hospital
Gifu, 501-1194
Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518
Saitama Medical University Hospital
Iruma-Gun, Saitama, 350-0495
Osaka Women's and Children's Hospital
Izumi, Osaka, 594-1101
Shimane University Hospital
Izumo, Shimane, 693-8501
National Hospital Organization Minami Kyoto Hospital
Jōyō, Kyoto, 610-0013
Saitama Medical Center
Kawagoe, Saitama, 350-8550
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, 216-8511
Hospital of the University of Occupational and Environmental Health
Kitakyushu, Fukuoka, 807-8556
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Takahashi Clinic
Kobe, Hyōgo, 657-0846
Kumamoto University Hospital
Kumamoto, 860-8556
National Hospital Organization Kure Medical Center & Chugoku Cancer Center
Kure, Hiroshima, 737-0023
Gunma University Hospital
Maebashi, Gunma, 371-8511
Miyazaki Prefectural Miyazaki Hospital
Miyazaki, 880-8510
Aichi Medical University Hospital
Nagakute, Aichi-ken, 480-1195
Arakawa Children's Clinic
Nagano, 381-0025
Nara Prefecture General Medical Center
Nara, 630-8054
Niigata University Medical & Dental Hospital
Niigata, 951-8520
Okayama Saiseikai General Hospital Outpatient Center
Okayama, 700-0013
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
Onomichi General Hospital
Onomichi, Hiroshima, 722-8508
Osaka City General Hospital
Osaka, 534-0021
Osaka City University Hospital
Osaka, 545-8586
Saitama Childrens Medical Center
Saitama, 330-8777
Saitama City Hospital
Saitama, 336-8522
Seirei Sakura Citizen Hospital
Sakura, Chiba, 285-8765
KKR Sapporo Medical Center
Sapporo, Hokkaido, 062-0931
East Japan Railway Company Sendai Branch Office JR Sendai Hospital
Sendai, Miyagi, 980-8508
National University Corporation Tohoku University Tohoku University Hospital
Sendai, Miyagi, 980-8574
Igarashi childrens clinic
Sendai, Miyagi, 981-3203
National Center for Child Health and Development
Setagaya-Ku, Tokyo, 157-8535
Keio University Hospital
Shinjuku, Tokyo, 160-8582
Shizuoka Childrens Hospital
Shizuoka, 420-8660
Osaka University Hospital
Suita, Osaka, 565-0871
Teikyo University Hospital
tabashi City, Tokyo, 173-8606
Takarazuka City Hospital
Takarazuka, Hyōgo, 665-0827
Toranomon Hospital
Tokyo, 105-8470
Tottori University Hospital
Yonago, Tottori, 683-8504
Oita University Hospital
Yufu, Oita Prefecture, 879-5593
About this study
Official title: A Phase 3, Open-Label, Randomized, Multicenter, 12-month, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin® Therapy in Japanese Pre-pubertal Children With Growth Hormone Deficiency
Treatment of children with growth failure due to growth hormone deficiency (GHD).
Primary • To evaluate the efficacy and safety of weekly MOD-4023 administration compared to daily Genotropin® administration in Japanese pre-pubertal children with GHD.
Secondary
- To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of three different doses of MOD-4023 in Japanese pre-pubertal children with GHD.
Read the detailed description
This is a 12-month, open-label, randomized, active controlled, parallel group study comparing the efficacy and safety of weekly MOD-4023 to daily recombinant human growth hormone (r-hGH), Genotropin ®. Both drugs will be injected subcutaneously (SC) using a pen device.
After a 4 week Screening period, patients meeting all the entry criteria and none of the exclusion criteria, will be eligible to participate in the study.
Eligible patients will be randomized in a 1:1 ratio, to receive either:
- MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
Or
- Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day which is equivalent to 0.175 mg/kg/week, divided equally into 7 daily injections over a week) SC injection for 12 months.
After the 6-week PK/PD sampling period, the dose of MOD-4023 and Genotropin® will be adjusted every 3 months based on a patient's body weight. Doses may be decreased for safety reasons according to the pre-defined dose-adjustment criteria (which will be based on the severity of adverse events (AEs) or repeated, elevated levels of IGF-1 Standard Deviation Score (SDS)).
The key safety data will be reviewed by an independent and external Data and Safety Monitoring Board (DSMB). DSMB review will also include a review of the number or percentage of patients requiring dose reductions due to AEs. Following the completion of the12-month treatment period, eligible patients will be consented to enroll into an open-label long term extension (LTE) period, and an amendment to this study protocol will be submitted prior to the first patient completes the 12 months treatment period. Eligible Genotropin®-treated patients will be switched to a MOD-4023 dose of 0.66 mg/kg/week in the LTE. The LTE is planned to continue until MOD-4023 marketing registration in Japan.
- Conditions
- Growth Hormone Deficiency
- Being tested
- MOD-4023, Genotropin
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOD-4023Drug
Also called Somatrogon
MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.
MOD-4023 will be administered as a SC injection once weekly, using a delivery device.
GenotropinDrug
Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.
A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.
Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week).
| Study group | Role | What they receive |
|---|---|---|
| MOD-4023 Treatment Arm | Experimental | MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week. Receives: Drug: MOD-4023 |
| Genotropin Treatment Arm | Active comparator | Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day). Receives: Drug: Genotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual Height Velocity (HV) After 12 Months
Annual Height Velocity in cm/year after 12 months of treatment.
Measured: 12 months
Secondary outcomes (3)
Height Velocity at 6 Months
Annualized height velocity (cm/year) for the MOD-4023 and the daily hGH treatment groups
Measured: 6 months
Change in Height Standard Deviation Score (SDS) Compared to Baseline After 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
Measured: 12 months
Change in Bone Maturation (BM) After 12 Months
Change in bone maturation (bone age / chronological age) with the method of TW2 using a central bone age reader.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start7 Dec 2017
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reiko Horikawa, M.D, Ph. D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874013
- Sponsor's protocol ID
- CP-4-009
- Status last verified
- Jul 2021
- First submitted
- 1 Oct 2018
- Last updated
- 12 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Horikawa R, Tanaka T, Hasegawa Y, Yorifuji T, Ng D, Rosenfeld RG, Hoshino Y, Okayama A, Ebata N, Hosoi M, Nakamuta S, Gomez R, Pastrak A, Castellanos O. Efficacy and safety of once-weekly somatrogon following up to 4 years of treatment in Japanese children with growth hormone deficiency: results from an open-label extension of a phase 3 study. Endocr J. 2026 Jan 6;73(1):21-32. doi: 10.1507/endocrj.EJ24-0625. Epub 2025 Oct 31.
PubMed 41183961
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label, Randomized, Multicenter, 12-month, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin® Therapy in Japanese Pre-pubertal Children With Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT03874013
- Acronym / sponsor ID
- CP-4-009
- Conditions
- Growth Hormone Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Posted 12 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of children with growth failure due to growth hormone deficiency (GHD).
Primary • To evaluate the efficacy and safety of weekly MOD-4023 administration compared to daily Genotropin® administration in Japanese pre-pubertal children with GHD.
Secondary
- To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of three different doses of MOD-4023 in Japanese pre-pubertal children with GHD.
Detailed description
This is a 12-month, open-label, randomized, active controlled, parallel group study comparing the efficacy and safety of weekly MOD-4023 to daily recombinant human growth hormone (r-hGH), Genotropin ®. Both drugs will be injected subcutaneously (SC) using a pen device.
After a 4 week Screening period, patients meeting all the entry criteria and none of the exclusion criteria, will be eligible to participate in the study.
Eligible patients will be randomized in a 1:1 ratio, to receive either:
- MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week.
Or
- Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day which is equivalent to 0.175 mg/kg/week, divided equally into 7 daily injections over a week) SC injection for 12 months.
After the 6-week PK/PD sampling period, the dose of MOD-4023 and Genotropin® will be adjusted every 3 months based on a patient's body weight. Doses may be decreased for safety reasons according to the pre-defined dose-adjustment criteria (which will be based on the severity of adverse events (AEs) or repeated, elevated levels of IGF-1 Standard Deviation Score (SDS)).
The key safety data will be reviewed by an independent and external Data and Safety Monitoring Board (DSMB). DSMB review will also include a review of the number or percentage of patients requiring dose reductions due to AEs. Following the completion of the12-month treatment period, eligible patients will be consented to enroll into an open-label long term extension (LTE) period, and an amendment to this study protocol will be submitted prior to the first patient completes the 12 months treatment period. Eligible Genotropin®-treated patients will be switched to a MOD-4023 dose of 0.66 mg/kg/week in the LTE. The LTE is planned to continue until MOD-4023 marketing registration in Japan.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOD-4023 Treatment Arm | Experimental | Drug: MOD-4023MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week. |
| Genotropin Treatment Arm | Active comparator | Drug: GenotropinGenotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day). |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Pre-pubertal child aged ≥ 3 years old, and not yet 10 years for girls (9 years and 364 days) or not yet 11 years for boys (10 years and 364 days), on the date of ICF signature, with either isolated GHD, or GH insufficiency as part of multiple pituitary hormone deficiency.
- Confirmed diagnosis of GHD by 2 different types of GH provocation tests (standardized on growth foundation data): defined as a peak serum GH level of ≤ 6.0 ng/mL or ≤ 16 ng/mL when conducting GHRP-2 provocation test.
- Prior local laboratory results will be accepted subject to pre-approval by the study medical monitor and if the tests were conducted as specified in the protocol.
- Bone age (BA) is not older than chronological age and should be less than 10 for girls and less than 11 for boys.
- Without prior exposure to any r-hGH therapy.
Key exclusion criteria (18 listed)
- Children with prior history of leukemia, lymphoma, sarcoma or any other forms of cancer.
- History of radiation therapy or chemotherapy
- Malnourished children defined as BMI < -2 SDS for age and sex
- Children with suspected psychosocial dwarfism by the discretion of the investigator
- Children born small for gestational age (SGA - birth weight and/or birth length < -2 SDS for gestational age)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOD-4023Also: SomatrogonMOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN. MOD-4023 will be administered as a SC injection once weekly, using a delivery device. | Drug | MOD-4023 Treatment Arm |
| GenotropinGenotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections. A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated. Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week). | Drug | Genotropin Treatment Arm |
Primary outcome
Annual Height Velocity (HV) After 12 Months
Time frame: 12 months
Annual Height Velocity in cm/year after 12 months of treatment.
3 secondary outcomes
Height Velocity at 6 Months
Time frame: 6 months
Change in Height Standard Deviation Score (SDS) Compared to Baseline After 12 Months
Time frame: 12 months
Change in Bone Maturation (BM) After 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41183961Horikawa R, Tanaka T, Hasegawa Y, Yorifuji T, Ng D, Rosenfeld RG, Hoshino Y, Okayama A, Ebata N, Hosoi M, Nakamuta S, Gomez R, Pastrak A, Castellanos O. Efficacy and safety of once-weekly somatrogon following up to 4 years of treatment in Japanese children with growth hormone deficiency: results from an open-label extension of a phase 3 study. Endocr J. 2026 Jan 6;73(1):21-32. doi: 10.1507/endocrj.EJ24-0625. Epub 2025 Oct 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reiko Horikawa, M.D, Ph. D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MOD-4023 and Genotropin in people with Growth Hormone Deficiency, run by OPKO Health, Inc. at 46 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual Height Velocity (HV) After 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03874013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.