Adult Growth Hormone Deficiency (AGHD) Clinical Trial
Official title:
An Open-Label, Long-Term Extension Study of the Safety of Somavaratan (VRS-317) in Adults With Growth Hormone Deficiency (GHD)
| Verified date | March 2023 |
| Source | Aravive, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (GHD).
| Status | Terminated |
| Enrollment | 36 |
| Est. completion date | January 11, 2018 |
| Est. primary completion date | January 11, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Versartis Inc. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. | From first dose of study drug up to approximately 2 years | |
| Secondary | Average Dose Level During Titration/Maintenance | Total average dose received by a participant during titration/maintenance has been reported. | Up to Month 12 | |
| Secondary | Number of Participants With Dose Adjustments | The number of participants with a dose adjustment (titrated up/down) at each month are summarized. | Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | |
| Secondary | Number of Participants Who Were Anti-drug Antibody (ADA) Positive | Up to approximately 2 years | ||
| Secondary | Number of Participants With Positive Neutralizing Antibodies (NABs) | Up to approximately 2 years | ||
| Secondary | Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period | Changes in the IGF-I levels were assessed as Standard Deviation Scores (SDS). The SDS was calculated as the actual value of IGF-I minus mean reference value of IGF-1 divided by reference standard deviation of IGF-I. The mean and the standard deviation (SD) vary depending on the age and sex of the participant. Change in IGF-I level (SDS) at specified timepoints from baseline was assessed. A higher score reflects a better outcome. | Baseline, Month 2 Day 1, Month 2 Day 8, Month 3 Day 1, Month 3 Day 8, Month 4 Day 1, Month 4 Day 8, Month 5 Day 1, Month 5 Day 8, Month 6 Day 1, Month 6 Day 8, Month 7 Day 1, Month 7 Day 8, Month 8 Day 1, Month 8 Day 8, Month 10 Day 1, and Month 10 Day 8 | |
| Secondary | Mean Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) SDS During Maintenance Period | Baseline up to Month 12 |