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

NCT ID: NCT01225666

Last Updated: 2019-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-04-30

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.

Conditions

Adult Growth Hormone Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Weekly low dose

MOD-4023

Group Type: EXPERIMENTAL

MOD-4023

Intervention Type: DRUG

liquid solution for subcutaneous injection - 30% of the cumulative weekly dose achieved with daily rhGH, Once weekly

Weekly middle dose

MOD-4023

Group Type: EXPERIMENTAL

MOD-4023

Intervention Type: DRUG

liquid solution for subcutaneous injection - 45% of the cumulative weekly dose achieved with daily rhGH, Once weekly

Weekly high dose

MOD-4023

Group Type: EXPERIMENTAL

MOD-4023

Intervention Type: DRUG

liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, Once weekly

Every-other week dose

MOD-4023

Group Type: EXPERIMENTAL

MOD-4023

Intervention Type: DRUG

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)

Interventions

MOD-4023

liquid solution for subcutaneous injection - 30% of the cumulative weekly dose achieved with daily rhGH, Once weekly

Intervention Type: DRUG

MOD-4023

liquid solution for subcutaneous injection - 45% of the cumulative weekly dose achieved with daily rhGH, Once weekly

Intervention Type: DRUG

MOD-4023

liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, Once weekly

Intervention Type: 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)

Intervention Type: DRUG

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 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

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OPKO Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Internal Clinic in University Hospital St. Anna

Brno, , Czechia

University Hospital, 2nd Department of Internal Medicine

Hradec Králové, , Czechia

State Health Center, 2nd department of internal medicine

Budapest, , Hungary

Semmelweis University, 2nd Clinic of Internal Medicine

Budapest, , Hungary

Petz Aladár County Teaching Hospital, Department of Endocrinology, Metabolism and Diabetology

Győr, , Hungary

University of Pécs, Medical School, 1st Department of Internal Medicine

Pécs, , Hungary

Szeged University, 1st Internal Medicine Clinic, Endocrinology

Szeged, , Hungary

Hetényi Géza Hospital and Out-Patient Clinic, 1st Department of Internal Medicine

Szolnok, , Hungary

Endocrinology and Metabolism Service, Hadassah-Hebrew University Medical Center

Jerusalem, , Israel

Institute of Endocrinology, Tel Aviv-Sourasky Medical Center

Tel Aviv, , Israel

Clinical Center of Serbia, Institute for endocrinology, diabetes and metabolism disease

Belgrade, , Serbia

. Department of Internal Medicine V, University Hospital Ruzinov

Bratislava, , Slovakia

Slovak Health University, Division of Endocrinology

Bratislava, , Slovakia

National Institute of Endocrinology and Diabetology

Ľubochňa, , Slovakia

University Medical Centre Ljubljana, Department of Endocrinology, Diabetes and Metabolic Diseases

Ljubljana, , Slovenia

Countries

Czechia; Hungary; Israel; Serbia; Slovakia; Slovenia

Other Identifiers

2010-019374-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CP-4-003

Identifier Type: -

Identifier Source: org_study_id