Versartis International Trial in Adults With Long-Acting Growth Hormone

Adult Growth Hormone Deficiency Clinical Trial

— VITAL  

Official title:

An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526420
• Other study ID #: 15VR7
• Status: Completed
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: October 2016

Study information

• Verified date: July 2022
• Source: Aravive, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD.

Description:

A Phase 2, dose finding safety study to evaluate an individualized monthly VRS-317 dosing regimen in adults with GHD. This is an open-label, international, multicenter study with VRS-317 treatment for five months. This treatment period will include monthly dose titrations until a subject's mean IGF-I SDS value is within a target range for two consecutive months. Subjects will be stratified into three cohorts based on sensitivity to rhGH.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years to 70 Years

Eligibility

Inclusion Criteria:

• Female subjects of childbearing potential must have negative pregnancy test and use appropriate contraceptive methods

• Subjects must have documented GHD during adulthood.

• Subjects taking other hormone replacement therapy must have been on a stable course of treatment for at least 3 months.

• Subjects with underlying disorders responsible for the subject's GHD must have been clinically stable for at least 6 months.

• Subjects receiving daily rhGH injections must washout for 14 days.

• Subjects must provide signed informed consent.

• Subjects must have a BMI (kg/m2) between 19.0 and 35.0.

Exclusion Criteria:

• Subjects with diabetes mellitus or inadequate glucose control

• Subjects with untreated adrenal insufficiency.

• Subjects with free thyroxine outside the normal reference range.

• Subjects currently taking oral glucocorticoids, except for physiological maintenance doses of oral glucocorticoids in subjects with multiple pituitary hormone deficiencies.

• Subjects with current significant cardiovascular disease, heart insufficiency of NYHA class > 2.

• Subjects with current significant cerebrovascular, pulmonary, neurological, renal, inflammatory, or hepatobiliary disease.

• Subjects with current papilledema.

• Subjects with a history of persistent or recurring migraines.

• Subjects with current edema (= CTCAE Grade 2).

• Subjects with current drug or alcohol abuse.

• Subjects with a documented history of HIV, current HBV or HCV infection

• Subjects with a prior history of malignancy excluding adequately treated non-melanoma skin cancers or in situ carcinoma of the cervix.

• Women who are pregnant or breastfeeding.

• Subjects with a significant abnormality in Screening laboratory results

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases

Intervention

Drug:
• somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly

Locations

Country	Name	City	State
Australia	St Vincent's Hospital	Fitzroy	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Germany	Charite-Universitätsmedizin	Berlin
Germany	Universitätsklinikum Essen	Essen
United Kingdom	Queen Elizabeth Hospital	Birmingham	B152gw
United Kingdom	Hull Royal Infirmary	Hull, East Yorkshire	Hu3 2rw
United Kingdom	William Harvey Research Institute	London	Ec1m 6bq
United Kingdom	The Christie NHS Foundation Trust	Manchester	M20 4bx
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	AMCR Institute Inc.	Escondido	California
United States	Therapeutic Research Institute of Orange County	Laguna Hills	California
United States	Palm Research Center	Las Vegas	Nevada
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Endocrine Associates of Dallas	Plano	Texas
United States	Swedish Medical Center	Seattle	Washington
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Versartis Inc.	Premier Research Group plc

Countries where clinical trial is conducted

United States,  Australia,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams	Safety observations include adverse events, concomitant medications, safety labs, vital signs and physical exams.	5 months
Primary	Starting doses (proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval )	To evaluate the starting doses of VRS-317 for each cohort as measured by the proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval (one month after the first dose)	5 months
Primary	Dose titration plan (proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration)	To evaluate the dose titration plan of VRS-317 for each cohort as measured by the proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration	5 months
Secondary	Immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers	To evaluate the immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers	5 months
Secondary	Immunogenicity of VRS-317 by detection of neutralizing antibodies (NAbs)	To evaluate the immunogenicity of VRS-317 by detection of neutralizing antibodies (NAb)	5 months

External Links

•   Company Website