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A Phase 3, Multicenter Study Designed To Evaluate The Efficacy And Safety Of A Long Acting Hgh Product (Mod-4023) In Adult Subjects With Growth Hormone Deficiency

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ClinicalTrials.gov Identifier: NCT01909479
Recruitment Status : Active, not recruiting
First Posted : July 26, 2013
Last Update Posted : September 21, 2016
Information provided by (Responsible Party):
Opko Biologics

Brief Summary:
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023).

Condition or disease Intervention/treatment Phase
Adult Growth Hormone Deficiency Drug: MOD-4023 Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2013
Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: MOD-4023 Drug: MOD-4023
Individualized once weekly dose of MOD-4023
Placebo Comparator: Placebo Other: Placebo
Once weekly administration of placebo

Primary Outcome Measures :
  1. Change in trunk FM, expressed in kilograms measured with DXA, from baseline to week 26 [ Time Frame: 26 weeks ]
  2. Safety measures [ Time Frame: 52 weeks ]
    AEs, abnormal laboratory results (including glucose metabolism), immunogenicity, ECG.

Secondary Outcome Measures :
  1. Change in total FM, expressed in kilograms, measured with DXA, from baseline to 26 and 52 weeks [ Time Frame: 52 weeks ]
  2. Change in lean body mass, expressed in kilograms measured with DXA, from baseline to 26 and 52 weeks [ Time Frame: 52 weeks ]
  3. Change in trunk FM, expressed in kilograms measured with DXA, from baseline to 52 weeks [ Time Frame: 52 weeks ]
  4. Change in trunk FM, expressed as % change from baseline, measured with DXA, from baseline to 26 and 52 weeks [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women between the age of 23 to 70 years old at screening, inclusive
  • GHD subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007).
  • No r-hGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational r-hGH or GH secretagogue product.
  • The IGF-I level at screening ≤-1 SDS of the age and sex normal ranges according to the central laboratory measurements
  • Subjects who are on a stable diet and exercise regime and do not have plans to modify their diet or exercise for at least 12 months
  • Subject had a DXA screening and the results are interpretable according to the study plan.

Exclusion Criteria:

  • Women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation)
  • Evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous MRI to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth).
  • History of any cancer. Exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. Patients with GHD attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record.
  • Signs of intracranial hypertension at screening
  • Heart insufficiency, NYHA class > 2 (Appendix B)
  • History of overt diabetes mellitus (including currently treated, well-controlled DM) defined according to the American Diabetes Association (ADA) Criteriaa. A history of gestational diabetes, resolved after childbirth, is not exclusionary.
  • History of Acromegaly

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 ClinicalTrials.gov identifier (NCT number): NCT01909479

United States, Pennsylvania
Prolor Biotech Investigational site
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Opko Biologics

Responsible Party: Opko Biologics
ClinicalTrials.gov Identifier: NCT01909479     History of Changes
Other Study ID Numbers: CP-4-005
2013-000830-37 ( EudraCT Number )
First Posted: July 26, 2013    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs