Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in Adult Growth Hormone Deficiency (AGHD)

NCT ID: NCT02719990

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-11
• Study Completion Date: 2018-01-11

Brief Summary

Open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (GHD).

Detailed Description

An open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with GHD. This multicenter study is open to participants completing a Versartis adult GHD study as well as approximately 40 new somavaratan naïve participants (either recombinant human growth hormone [rhGH] treatment naïve or currently receiving daily rhGH therapy). All participants will receive twice-monthly (every 15 days ± 2 days) subcutaneous (SC) somavaratan. Doses will be titrated to each participant's individual insulin-like growth factor-I (IGF-I) responses based on the IGF-I level 7 days post-dose until a maintenance dose is achieved. Participants receiving somavaratan in a previous somavaratan study will have their dose decreased by half (minimum dose of 20 milligrams [mg], 40 mg for women on estrogen, rounded down to the nearest even number) and will be titrated per the Dose Titration Plan. New participants enrolling in this study will be assigned to one of two cohorts based on sensitivity to rhGH and titrated per the Dose Titration Plan.

Conditions

Adult Growth Hormone Deficiency (AGHD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Somavaratan

Long-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly in adult participants with GHD

Group Type: EXPERIMENTAL

somavaratan

Intervention Type: DRUG

Long-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly

Interventions

somavaratan

Long-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly

Intervention Type: DRUG

Other Intervention Names

VRS-317

Eligibility Criteria

Inclusion Criteria

• Female participants of childbearing potential must have negative pregnancy test and use appropriate contraceptive methods
• Documented GHD during adulthood
• Participants naive to somavaratan must have an IGF-1 SDS value ≤ 0 at Screening
• Participants taking other hormone replacement therapy must have been on a stable course of treatment for at least 3 months
• Underlying disorders responsible for the participant's GHD must have been clinically stable for at least 6 months
• Participants receiving daily rhGH injections must washout for ≥ 14 days
• Body mass index (BMI) (kilograms [kg]/meter square [m^2]) between 18.0 and 40.0

Exclusion Criteria

• Untreated adrenal insufficiency
• Recently diagnosed thyroid dysfunction which is not being treated or has not been stable on therapy for at least 3 months
• Currently taking anti-inflammatory dose of glucocorticoids that could potentially compromise safety or efficacy assessments
• Currently taking a GHRH or IGF-I product
• Current significant cardiovascular disease, heart insufficiency of New York Heart Association (NYHA) class > 2
• Current significant disease thought to increase risk of receiving growth hormone or confound assessment of study outcomes
• History of diabetes mellitus or inadequate glucose control
• Current drug or alcohol abuse
• Current human immunodeficiency virus (HIV) wasting syndrome (HIV testing not required)
• History of malignancy in adulthood (participants with a history of childhood malignancy that were subsequently treated with rhGH in childhood and remain GHD in adulthood may be enrolled)
• Women who are pregnant or breastfeeding
• Treatment with an investigational drug other than somavaratan within 30 days prior to Screening
• A significant abnormality in Screening laboratory results

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versartis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Will Charlton, MD

Role: STUDY_DIRECTOR

Sponsor GmbH

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15VR8

Identifier Type: -

Identifier Source: org_study_id