Adult Growth Hormone DeficiencyPhase 2NCT01225666
MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)
A Phase 2 study testing MOD-4023 in people with Adult Growth Hormone Deficiency, run by OPKO Health, Inc. at 15 sites in 6 countries.
Trial summary
This study aims to assess the safety, tolerability and Pharmacokinetics/ Pharmacodynamics (PK/PD) profile of three doses of MOD-4023 on a weekly regime and one dose on an every-other-week regime administered for a period of 4 weeks in Growth Hormone Deficient Adult (GHDA) patients who previously were on a stable r-hGH… Read more about this study
- Who is it for?
- Ages 23 to 60 years
- Conditions the study is for
- Adult Growth Hormone Deficiency
- What is being tested?
- MOD-4023
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 15 sitesin 6 countries
- Study dates
- Aug 2010to Apr 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 23 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Genders Eligible for Study: Both
- Ages Eligible for Study: Males - 23 to 60 years, Females - 23 to 50 years.
- GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007).
- Patients using hormonal replacement therapy(s) for deficiencies of other hypothalamo-pituitary axes must be on an optimized and stable treatment regimen (hormone levels within normal ranges on screening) for at least three months prior to screening:
- Temporary adjustment of glucocorticoid replacement therapy, as appropriate, is acceptable.
- Peripheral thyroid hormones (FT4, FT3) within the normal range.
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- Fertile females must agree to use appropriate contraceptive methods
- Female patients must have a negative serum pregnancy test at inclusion.
- Growth Hormone (GH) replacement therapy for more than 6 months with registered GH product.
- The IGF-I level at screening within -1.5 to +1.5 SDS of the age and sex normal ranges according to the central laboratory measurements.
- Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive
- Confirmed to be negative for anti r-hGH antibodies at the time of screening.
- Willing and able to provide written informed consent prior to performing any study procedures.
Who cannot join
- Females who are pregnant or breast-feeding
- Evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months (confirmed by computer tomography (CT) or magnetic resonance imaging (MRI) scan (with contrast) within 3 months prior to study entry or at screening).
- History of malignancy other than i) cranial irradiation (for cranial tumor or leukemia) causing GHD or ii) fully treated basal cell carcinoma
- Signs of intracranial hypertension at screening
- Heart insufficiency, NYHA class greater than 2
- History of impaired glucose tolerance, insulin resistance or overt diabetes mellitus defined according to the American Diabetes Association (ADA) Criteria
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- Impaired liver function defined as elevation of liver enzymes >2 x upper limit of normal
- Impaired kidney function defined as increased serum creatinine levels >1.5 x upper limit of normal
- Active acromegaly in the last 18 months and less than 6 months of active r- hGH replacement therapy
- Active Carpal tunnel syndrome
- Prader-Willi syndrome
- Active Cushing's syndrome within the last 12 months
- Systemic corticosteroids other than in replacement doses within the 3 months before study entry (temporary adjustment of glucocorticoids, as appropriate, is acceptable)
- Anabolic steroids other than gonadal steroid replacement therapy within 2 months before study entry
- History of non-compliance with medications, un-cooperativeness or drug abuse
- Blood donation or any major blood loss >500 mL within the past 90 days prior to study entry
- Patients who, based on the investigator's judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Conditions may include cardiovascular, peripheral vascular, pulmonary, hepatic, renal, or neurological disease, as determined by medical history, physical examination, laboratory tests or ECG
- Patients who participated in any investigational medicinal product (IMP) study within the last 2 months
- History of positive serology to HBC, HBV and HIV
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Hungary6 sites
State Health Center, 2nd department of internal medicine
Budapest, 1062
Semmelweis University, 2nd Clinic of Internal Medicine
Budapest, 1088
Petz Aladár County Teaching Hospital, Department of Endocrinology, Metabolism and Diabetology
Győr, 9023
University of Pécs, Medical School, 1st Department of Internal Medicine
Pécs, 7624
Szeged University, 1st Internal Medicine Clinic, Endocrinology
Szeged, 6720
Hetényi Géza Hospital and Out-Patient Clinic, 1st Department of Internal Medicine
Szolnok, 5004
Slovakia3 sites
. Department of Internal Medicine V, University Hospital Ruzinov
Bratislava, 82104
Slovak Health University, Division of Endocrinology
Bratislava, 83307
National Institute of Endocrinology and Diabetology
Ľubochňa, 034 91
Czechia2 sites
Internal Clinic in University Hospital St. Anna
Brno, 656 91
University Hospital, 2nd Department of Internal Medicine
Hradec Králové, 500 05
Israel2 sites
Endocrinology and Metabolism Service, Hadassah-Hebrew University Medical Center
Jerusalem, 91120
Institute of Endocrinology, Tel Aviv-Sourasky Medical Center
Tel Aviv, 64239
Serbia1 site
Clinical Center of Serbia, Institute for endocrinology, diabetes and metabolism disease
Belgrade, 11000
Slovenia1 site
University Medical Centre Ljubljana, Department of Endocrinology, Diabetes and Metabolic Diseases
Ljubljana, 1525
About this study
Official title: A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)
This study aims to assess the safety, tolerability and Pharmacokinetics/ Pharmacodynamics (PK/PD) profile of three doses of MOD-4023 on a weekly regime and one dose on an every-other-week regime administered for a period of 4 weeks in Growth Hormone Deficient Adult (GHDA) patients who previously were on a stable r-hGH treatment. An additional extension period of 16 weeks once-weekly administration of MOD-4023 aims to confirm the dose selection for future trials.
Read the detailed description
The study is a phase II, randomized, open-label, parallel, 4 active treatment arms study to evaluate the safety, tolerability and PK/PD profile of MOD-4023 in pre-treated, normalized, GHD adults.
The study is conducted in 2 stages. Stage I is a 4-week treatment period with 4 different dose levels/dosing regimens.
Stage II is a 16-week treatment-extension period in which all the patients will start with the same dose (derived from stage I) and will be dose titrated to maintain IGF-1 levels within the normal range.
- Conditions
- Adult Growth Hormone Deficiency
- Being tested
- MOD-4023
- Keywords
- MOD-4023, Growth Hormone Deficient Adults, Phase II
- 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
liquid solution for subcutaneous injection - 30% of the cumulative weekly dose achieved with daily rhGH, Once weekly
MOD-4023Drug
liquid solution for subcutaneous injection - 45% of the cumulative weekly dose achieved with daily rhGH, Once weekly
MOD-4023Drug
liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, Once weekly
MOD-4023Drug
liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, every-other week (50% of the two-weekly cumulative dose)
| Study group | Role | What they receive |
|---|---|---|
| Weekly low dose | Experimental | MOD-4023 Receives: Drug: MOD-4023 |
| Weekly middle dose | Experimental | MOD-4023 Receives: Drug: MOD-4023 |
| Weekly high dose | Experimental | MOD-4023 Receives: Drug: MOD-4023 |
| Every-other week dose | Experimental | MOD-4023 Receives: Drug: MOD-4023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Safety and Tolerability
Adverse events (AE's), vital signs, electrocardiogram (ECG), laboratory tests, local reaction
Measured: Following 4 weeks of MOD-4023 treatment
Maintenance of normal Insulin-like-Growth-Factor-1 (IGF-1)levels in GHDA
The primary efficacy endpoint will be the mean time interval of IGF-I levels that lay within ±1.5 SDS after the last dose administration during stage I (4w treatment) expressed in hours.
Measured: Following 4 weeks MOD-4023 treatment
Secondary outcomes (3)
Change of IGF-I levels over time expressed in absolute and SDS values
Measured: Following 4 and 16 weeks of MOD-4023 treatment
Change of IGFBP-3 over time expressed in absolute values
Measured: Following 4 and 16 weeks of MOD-4023 treatment
Number of IGF-1 normalized patients in stage II
Number of patients achieving normalization of IGF-1 levels during dose titration 16-week treatment extension
Measured: Following 16 weeks of MOD-4023 treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225666
- Sponsor's protocol ID
- CP-4-003
- Other IDs
- 2010-019374-32
- Status last verified
- Sep 2019
- First submitted
- 19 Oct 2010
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)
- ClinicalTrials.gov ID
- NCT01225666
- Acronym / sponsor ID
- CP-4-003
- Conditions
- Adult Growth Hormone Deficiency
- Keywords
- MOD-4023, Growth Hormone Deficient Adults, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the safety, tolerability and Pharmacokinetics/ Pharmacodynamics (PK/PD) profile of three doses of MOD-4023 on a weekly regime and one dose on an every-other-week regime administered for a period of 4 weeks in Growth Hormone Deficient Adult (GHDA) patients who previously were on a stable r-hGH treatment. An additional extension period of 16 weeks once-weekly administration of MOD-4023 aims to confirm the dose selection for future trials.
Detailed description
The study is a phase II, randomized, open-label, parallel, 4 active treatment arms study to evaluate the safety, tolerability and PK/PD profile of MOD-4023 in pre-treated, normalized, GHD adults.
The study is conducted in 2 stages. Stage I is a 4-week treatment period with 4 different dose levels/dosing regimens.
Stage II is a 16-week treatment-extension period in which all the patients will start with the same dose (derived from stage I) and will be dose titrated to maintain IGF-1 levels within the normal range.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Weekly low dose | Experimental | Drug: MOD-4023MOD-4023 |
| Weekly middle dose | Experimental | Drug: MOD-4023MOD-4023 |
| Weekly high dose | Experimental | Drug: MOD-4023MOD-4023 |
| Every-other week dose | Experimental | Drug: MOD-4023MOD-4023 |
Who may qualify
- Ages
- 23 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Genders Eligible for Study: Both
- Ages Eligible for Study: Males - 23 to 60 years, Females - 23 to 50 years.
- GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007).
- Patients using hormonal replacement therapy(s) for deficiencies of other hypothalamo-pituitary axes must be on an optimized and stable treatment regimen (hormone levels within normal ranges on screening) for at least three months prior to screening:
- Fertile females must agree to use appropriate contraceptive methods
Key exclusion criteria (19 listed)
- Females who are pregnant or breast-feeding
- Evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months (confirmed by computer tomography (CT) or magnetic resonance imaging (MRI) scan (with contrast) within 3 months prior to study entry or at screening).
- History of malignancy other than i) cranial irradiation (for cranial tumor or leukemia) causing GHD or ii) fully treated basal cell carcinoma
- Signs of intracranial hypertension at screening
- Heart insufficiency, NYHA class greater than 2
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-4023liquid solution for subcutaneous injection - 30% of the cumulative weekly dose achieved with daily rhGH, Once weekly | Drug | Weekly low dose |
| MOD-4023liquid solution for subcutaneous injection - 45% of the cumulative weekly dose achieved with daily rhGH, Once weekly | Drug | Weekly middle dose |
| MOD-4023liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, Once weekly | Drug | Weekly high dose |
| MOD-4023liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, every-other week (50% of the two-weekly cumulative dose) | Drug | Every-other week dose |
Primary outcome
1. Safety and Tolerability
Time frame: Following 4 weeks of MOD-4023 treatment
Adverse events (AE's), vital signs, electrocardiogram (ECG), laboratory tests, local reaction
Maintenance of normal Insulin-like-Growth-Factor-1 (IGF-1)levels in GHDA
Time frame: Following 4 weeks MOD-4023 treatment
The primary efficacy endpoint will be the mean time interval of IGF-I levels that lay within ±1.5 SDS after the last dose administration during stage I (4w treatment) expressed in hours.
3 secondary outcomes
Change of IGF-I levels over time expressed in absolute and SDS values
Time frame: Following 4 and 16 weeks of MOD-4023 treatment
Change of IGFBP-3 over time expressed in absolute values
Time frame: Following 4 and 16 weeks of MOD-4023 treatment
Number of IGF-1 normalized patients in stage II
Time frame: Following 16 weeks of MOD-4023 treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MOD-4023 in people with Adult Growth Hormone Deficiency, run by OPKO Health, Inc. at 15 sites in 6 countries.
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 13 inclusion and 19 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 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Hungary, Slovakia, Czechia, Israel, Serbia and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1. Safety and Tolerability (time frame: Following 4 weeks of MOD-4023 treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2019; AzTrials last refreshed its copy on 1 Nov 2026.