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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Prolor Biotech, Inc.
Sponsor:
Information provided by (Responsible Party):
Prolor Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01909479
First received: July 24, 2013
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Adult Growth Hormone Deficiency
Drug: MOD-4023
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Prolor Biotech, Inc.:

Primary Outcome Measures:
  • Change in trunk FM, expressed in kilograms measured with DXA, from baseline to week 26 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Safety measures [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    AEs, abnormal laboratory results (including glucose metabolism), immunogenicity, ECG.


Secondary Outcome Measures:
  • Change in total FM, expressed in kilograms, measured with DXA, from baseline to 26 and 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change in lean body mass, expressed in kilograms measured with DXA, from baseline to 26 and 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change in trunk FM, expressed in kilograms measured with DXA, from baseline to 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change in trunk FM, expressed as % change from baseline, measured with DXA, from baseline to 26 and 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 189
Study Start Date: June 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MOD-4023 Drug: MOD-4023
Individualized once weekly dose of MOD-4023
Placebo Comparator: Placebo Other: Placebo
Once weekly administration of placebo

  Eligibility

Ages Eligible for Study:   23 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01909479

Contacts
Contact: Eyal Fima, Ph.D. +972-8-9543103 eyal@prolor-biotech.com
Contact: Leanne Amitzi, M.Sc. +972-8-9543129 leanne@prolor-biotech.com

Locations
United States, Pennsylvania
Prolor Biotech Investigational site Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Leanne Amitzi, MSc       leanne@prolor-biotech.com   
Sponsors and Collaborators
Prolor Biotech, Inc.
  More Information

No publications provided

Responsible Party: Prolor Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01909479     History of Changes
Other Study ID Numbers: CP-4-005, 2013-000830-37
Study First Received: July 24, 2013
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on October 29, 2014