Working… Menu

MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01225666
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : October 8, 2019
Information provided by (Responsible Party):
OPKO Health, Inc.

Brief 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 treatment. An additional extension period of 16 weeks once-weekly administration of MOD-4023 aims to confirm the dose selection for future trials.

Condition or disease Intervention/treatment Phase
Adult Growth Hormone Deficiency Drug: MOD-4023 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)
Study Start Date : August 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : April 2012

Arm Intervention/treatment
Experimental: Weekly low dose
Drug: MOD-4023
liquid solution for subcutaneous injection - 30% of the cumulative weekly dose achieved with daily rhGH, Once weekly

Experimental: Weekly middle dose
Drug: MOD-4023
liquid solution for subcutaneous injection - 45% of the cumulative weekly dose achieved with daily rhGH, Once weekly

Experimental: Weekly high dose
Drug: MOD-4023
liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, Once weekly

Experimental: Every-other week dose
Drug: MOD-4023
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)

Primary Outcome Measures :
  1. 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

  2. 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.

Secondary Outcome Measures :
  1. Change of IGF-I levels over time expressed in absolute and SDS values [ Time Frame: Following 4 and 16 weeks of MOD-4023 treatment ]
  2. Change of IGFBP-3 over time expressed in absolute values [ Time Frame: Following 4 and 16 weeks of MOD-4023 treatment ]
  3. Number of IGF-1 normalized patients in stage II [ Time Frame: Following 16 weeks of MOD-4023 treatment ]
    Number of patients achieving normalization of IGF-1 levels during dose titration 16-week treatment extension

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   23 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01225666

Layout table for location information
Internal Clinic in University Hospital St. Anna
Brno, Czechia, 656 91
University Hospital, 2nd Department of Internal Medicine
Hradec Kralove, Czechia, 500 05
State Health Center, 2nd department of internal medicine
Budapest, Hungary, 1062
Semmelweis University, 2nd Clinic of Internal Medicine
Budapest, Hungary, 1088
Petz Aladár County Teaching Hospital, Department of Endocrinology, Metabolism and Diabetology
Gyor, Hungary, 9023
University of Pécs, Medical School, 1st Department of Internal Medicine
Pécs, Hungary, 7624
Szeged University, 1st Internal Medicine Clinic, Endocrinology
Szeged, Hungary, 6720
Hetényi Géza Hospital and Out-Patient Clinic, 1st Department of Internal Medicine
Szolnok, Hungary, 5004
Endocrinology and Metabolism Service, Hadassah-Hebrew University Medical Center
Jerusalem, Israel, 91120
Institute of Endocrinology, Tel Aviv-Sourasky Medical Center
Tel Aviv, Israel, 64239
Clinical Center of Serbia, Institute for endocrinology, diabetes and metabolism disease
Belgrade, Serbia, 11000
. Department of Internal Medicine V, University Hospital Ruzinov
Bratislava, Slovakia, 82104
Slovak Health University, Division of Endocrinology
Bratislava, Slovakia, 83307
National Institute of Endocrinology and Diabetology
Lubochna, Slovakia, 034 91
University Medical Centre Ljubljana, Department of Endocrinology, Diabetes and Metabolic Diseases
Ljubljana, Slovenia, 1525
Sponsors and Collaborators
OPKO Health, Inc.
Layout table for additonal information
Responsible Party: OPKO Health, Inc. Identifier: NCT01225666    
Other Study ID Numbers: CP-4-003
2010-019374-32 ( EudraCT Number )
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: September 2019
Keywords provided by OPKO Health, Inc.:
Growth Hormone Deficient Adults
Phase II