The VITAL study
Research type
Research Study
Full title
An Open-Label, Dose Finding, International Phase 2 Study with Once Monthly Subcutaneous Somavaratan (VRS-317) in Adult Growth Hormone Deficiency (GHD) Versartis International Trial in Adults with Long Acting Growth Hormone. The VITAL study
IRAS ID
184455
Contact name
Peter Trainer
Contact email
Sponsor organisation
Versartis Inc.
Eudract number
2015-002072-24
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
Somavaratan (VRS-317 ) is an investigational drug that is a long-acting growth hormone. This dose finding safety study will evaluate an individualised monthly Somavaratan dosing regimen in adults with growth hormone deficiency (GHD). This is an open-label, international, multicentre study with somavaratan treatment for five months. This treatment period will include monthly dose titrations until a patient’s mean IGF-I SDS value is within target range of 0 to 1.50 SDS for two consecutive months.
The purpose of this research study is to see:
• How safe and tolerable somavaratan is when injected subcutaneously
• How long the injected somavaratan stays in the body
• How to find the best dose for each person based on his/her response to the drug.Daily subcutaneous dosing of rhGH is the currently approved therapy for the replacement of insufficient endogenous secretion of GH, long-acting rhGH offers the possibilities of fewer injections, enhanced compliance and attainment of improved treatment outcomes. This study will be conducted at approximately 20 centres globally. It may involve as many as 40 adult participants, diagnosed with GHD. Each participant in this study will receive a maximum of 5 injections of somavaratan subcutaneously. Participants will be enrolled in one of three treatment groups based on age and whether they are taking the hormone oestrogen by mouth. Patients will receive a subcutaneous (under the skin) injection of somavaratan once a month for five (5) months.
Patients will be monitored for safety throughout their participation in the study. Safety will be monitored at each clinic visit by physical examination, inspection of injection sites, vital signs, clinical laboratory assessments (including complete blood count, chemistry, lipid profile, hsCRP, urinalysis, measurements of adrenal function, thyroid function, and glucose metabolism), and immunogenicity assessments. Patients will be stratified into three cohorts, based on sensitivity to rhGH A: patient’s ≥35 years of age, B: patients <35 years of age, and C: women on oral oestrogens, regardless of age.
The following evaluations will be performed to assess study eligibility and safety, Physical examination including injection site(s) evaluation, Vital signs including sitting blood pressure, pulse rate, temperature and respiratory rate, Laboratory tests: IGF-I levels, complete blood count, chemistry, fasting plasma glucose and insulin, haemoglobin A1c, thyroid function tests (Free T4 and TSH), pregnancy testing (for women of childbearing potential), lipid profile, hsCRP, ACTH stimulation tests, urinalysis, 12-lead ECGs, and antibodies to somavaratan and rhGH, Adverse events (AEs), Concomitant medications, Safety monitoring will continue up to 30 days after study completion (60 days [±3 days] after final dose).
All patients will be eligible to enrol in an open-label Extension Study (Protocol 15VR8) after completing five months of treatment. Any patient not dose titrated after five months of treatment may continue treatment and complete titration in the Extension Study. Patients who discontinue early or elect not to enrol in the Extension Study will have a follow up visit 60 days (±3 days) after their last dose to assess safety.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0696
Date of REC Opinion
19 Oct 2015
REC opinion
Further Information Favourable Opinion