Loading clinical trials...

MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT01225666•OPKO Health, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

23 - 60 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

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
+9 more criteria

Locations (15)

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

Key Dates

Start Date

August 1, 2010

Primary Completion Date

July 1, 2011

Completion Date

April 1, 2012

Last Updated

October 8, 2019

Enrollment

ACTUAL participants

Conditions

Adult Growth Hormone Deficiency

Interventions

MOD-4023

DRUG

MOD-4023

DRUG

MOD-4023

DRUG

MOD-4023

DRUG

Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®

NCT05230550

Adult Growth Hormone Deficiency

View study

NOT_YET_RECRUITINGPHASE2

A Study of GS3-007a for Oral Suspension in the Diagnosis of Adult Growth Hormone Deficiency (AGHD)

NCT07259564

Adult Growth Hormone Deficiency (AGHD)

View study

COMPLETEDPHASE1

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®

A Study of GS3-007a for Oral Suspension in the Diagnosis of Adult Growth Hormone Deficiency (AGHD)

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

Observational Prospective Study on Patients Treated With Norditropin®