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

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Brief Title

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

Official Title

A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)

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.

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 Phase

Phase 2

Study Type


Primary Outcome

1. Safety and Tolerability

Secondary Outcome

 Change of IGF-I levels over time expressed in absolute and SDS values


Adult Growth Hormone Deficiency



Study Arms / Comparison Groups

 Weekly low dose
Description:  MOD-4023


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

August 2010

Completion Date

April 2012

Primary Completion Date

July 2011

Eligibility Criteria

        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

               -  Temporary adjustment of glucocorticoid replacement therapy, as appropriate, is

               -  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

          -  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

        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

          -  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

          -  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




23 Years - 60 Years

Accepts Healthy Volunteers



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Location Countries


Location Countries


Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

OPKO Health, Inc.

Study Sponsor

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Verification Date

September 2019