A Multi-Dose Study to Assess Tolerability, Safety and Pharmacology of hGH-ViaDerm™ System in Adults With GH-Deficiency

This study has been completed.
Sponsor:
Collaborators:
Teva Pharmaceutical Industries
TransPharma Medical
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
ClinicalTrials.gov Identifier:
NCT00455260
First received: April 2, 2007
Last updated: August 30, 2013
Last verified: April 2009
  Purpose

This study aims to examine the safety, tolerability and pharmacokinetics of transdermal delivery of human Growth Hormone (hGH or somatropin) using the ViaDerm device in adult patients with Growth Hormone Deficiency Syndrome.


Condition Intervention Phase
Growth Hormone Deficiency
Drug: hGH-ViaDerm™ System (hGH or somatropin)
Device: hGH-ViaDerm™ System
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study, to Assess Tolerability, Safety, Pharmacokinetic and Pharmacodynamic Profiles of hGH-ViaDerm™ System in Adult Subjects With Growth Hormone Deficiency

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • AE [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]
  • Laboratory values [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]
  • Patch application site reaction: Skin irritation- erythema, edema [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]
  • Patch application site reaction: Pain - Visual Analogue Scale [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]
  • Proportion of subjects (%) who discontinue the study [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]
  • Proportion of subjects (%) who discontinue the study due to AEs [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Somatropin exposure including Cmax, Tmax, AUC, AUC, Ke, and T1/2. [ Time Frame: 36 days ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Human IGF-1 levels and AUC. [ Time Frame: 36 days ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: hGH-ViaDerm™ System (hGH or somatropin)
    transdermal patch; Group 1: 0.2 mg/day SC hGH during Period I, and 0.5 mg per transdermal patch during Period III (expected equivalent dose to SC 0.2 mg/day) Group 2: 0.4 mg/day SC hGH during Period I, and 2.0 mg per transdermal patch during Period III (expected equivalent dose to SC 0.4 mg/day) Group 3: 1.0 mg/day SC hGH during Period I, and 5.0 mg per transdermal patch during Period III (expected equivalent dose to 1.0 mg/day)
    Device: hGH-ViaDerm™ System

    The hGH-ViaDerm™ System is a transdermal delivery system for somatropin (hGH, rDNA origin).

    The ViaDerm System™ consists of a medical device component and a printed dry hGH patch component. The device component is comprised of two primary elements: a reusable, computer mouse-like electronic controller and a disposable sterile array, which is inserted onto the base of the controller, delivers RF-current to ablate cells and creates microscopic throughways, termed RF-MicroChannels™, across the stratum corneum into the upper epidermis. The drug component consists of a unique circular transdermal dry hGH patch formulated specifically for use with the ViaDerm™ device. hGH is delivered by passive diffusion through the RF-MicroChannels™ into the systemic circulation system.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Ages Eligible for Study: 20 Years - 60 Years, Genders Eligible for Study: Both

  1. Clinical diagnosis of Adult Growth Hormone Deficiency (AGHD) meeting one of the following criteria:

    • Three or more additional pituitary hormone deficiencies, based on well documented medical history from up to 10 years prior to screening, and/or serum IGF-1 levels below 2 SD from normal level, measured up to 4 months prior to screening.
    • One or two additional pituitary hormone deficiencies with one GH stimulating test performed within 10 years prior to screening: Insulin Tolerance test with GH levels less than 5.1 µg/L or ARG-GHRH with GH levels less than 4.1 µg/L.
    • Isolated GH deficient subjects with two well-documented GH stimulating tests performed within 10 years prior to screening. Insulin Tolerance test with GH levels less than 5.1 µg/L or ARG-GHRH with GH levels less than 4.1 µg/L.
    • In childhood onset AGHD, confirmation of GHD following attainment of full height.
  2. Subjects using hormone replacement therapy for additional pituitary deficits must be on an optimized treatment regimen for at least three months prior to screening.
  3. Willing and able to provide written informed consent prior to performing any study procedures.

Exclusion Criteria:

  1. GH therapy within one month prior to study entry.
  2. For female subjects: pregnancy or lactation or use of oral contraception or unacceptable method of contraception throughout the study.
  3. Active acromegaly in the last 5 years.
  4. Carpal tunnel syndrome.
  5. Prader-Willi syndrome.
  6. Active Cushing's syndrome within the last 12 months.
  7. Non-compliance for upper arm SC injection or patch application.
  8. Skin color or tattoo that would not enable detection of erythema.
  9. Upper extremities with skin marks, bruises, cuts, abrasions on the upper arm.
  10. Dense and dark hair growth on upper extremities.
  11. History of skin hypersensitivity and/or allergies.
  12. Known hypersensitivity to somatropin or mannitol
  13. Evidence of active malignancy.
  14. Previous use of chemotherapy, immunosuppressive or radiation therapy, except for treatment of pituitary disease.
  15. Serum glucose (fasting) > 126 mg/dl.
  16. Known or suspected HIV-positive subjects or subjects with advanced diseases such as AIDS, Hepatitis C, Hepatitis B or tuberculosis.
  17. Subjects 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, vascular, pulmonary, hepatic, renal, or neurological disease, as determined by medical history, physical examination, laboratory tests or ECG.
  18. BMI < 19 and ≥ 35 kg/m2.
  19. Weight reducing drugs or appetite suppressants.
  20. Estrogen replacement therapy except transdermal patch.
  21. Any psychological condition which may influence the compliance with the study requirements.
  22. Unstabilized antidepressant or antipsychotic medication therapy within 2 months prior to screening.
  23. Subjects with a known history of alcohol abuse.
  24. Subjects who received blood or plasma derivatives in the three months preceding screening.
  25. Subjects who donated blood in the preceding three months of screening or intend to make a blood donation during the study, or within the three months following the study completion.
  26. Subjects who have participated in another clinical study of any kind (drug or device) in the one month prior to screening.
  27. Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.
  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: NCT00455260

Sponsors and Collaborators
Teva Neuroscience, Inc.
Teva Pharmaceutical Industries
TransPharma Medical
Investigators
Study Director: Noa Avisar, PhD Teva Pharmaceutical Industries
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
ClinicalTrials.gov Identifier: NCT00455260     History of Changes
Other Study ID Numbers: GH-VD-102
Study First Received: April 2, 2007
Last Updated: August 30, 2013
Health Authority: Israel: Ministry of Health
Ukraine: Ministry of Health

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

ClinicalTrials.gov processed this record on July 22, 2014