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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02526420




Registration number
NCT02526420
Ethics application status
Date submitted
13/08/2015
Date registered
18/08/2015
Date last updated
9/11/2016

Titles & IDs
Public title
Versartis International Trial in Adults With Long-Acting Growth Hormone
Scientific title
An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)
Secondary ID [1] 0 0
15VR7
Universal Trial Number (UTN)
Trial acronym
VITAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult Growth Hormone Deficiency 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - somavaratan

Experimental: Cohort A: Somavaratan in Older Adults - Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects >= 35 years of age

Experimental: Cohort B: Somavaratan in Younger Adults - Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects < 35 years of age

Experimental: Cohort C: Somavaratan in Women on Estrogen - Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in female subjects on oral estrogen (regardless of age)


Treatment: Drugs: somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
5 months
Primary outcome [2] 0 0
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)
Timepoint [2] 0 0
5 months
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
5 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
5 months
Secondary outcome [2] 0 0
Immunogenicity of VRS-317 by detection of neutralizing antibodies (NAbs) - To evaluate the immunogenicity of VRS-317 by detection of neutralizing antibodies (NAb)
Timepoint [2] 0 0
5 months

Eligibility
Key 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.
Minimum age
23 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Nevada
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Germany
State/province [7] 0 0
Essen
Country [8] 0 0
United Kingdom
State/province [8] 0 0
B152gw
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Ec1m 6bq
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Hu3 2rw
Country [11] 0 0
United Kingdom
State/province [11] 0 0
M20 4bx

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Versartis Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Premier Research Group plc
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for
five months in adults with GHD.
Trial website
https://clinicaltrials.gov/show/NCT02526420
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniela Rogoff, MD, PhD
Address 0 0
Versartis Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications