Primary outcomeCount of participants· From first dose of study drug up to approximately 2 years
Number of Participants With Adverse Events (AEs)
| Group | Value (Participants) |
|---|---|
| Somavaratan | 30 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataOpen-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in Adult Growth Hormone Deficiency (AGHD)
NCTNCT02719990 (opens ClinicalTrials.gov in a new tab)Other id15VR8
This trial was stopped early.
Reason given at the registry: Phase 3 clinical trial of somavaratan in pediatric growth hormone deficiency (PGHD) did not meet its primary endpoint of non-inferiority.
Results were posted for this trial.
This trial does not test a peptide that PepBank tracks.
- Names HGH (somatotropin), does not test it. It appears in the summary.
Overview
- Status
- Terminated
- Phase
- Phase 2
- Enrollment
- 36 participants (actual)
- Sponsor
- Versartis Inc. · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
- Not stated
- Start
- 11 Feb 2016
- Primary completion
- 11 Jan 2018
- Completion
- 11 Jan 2018
- First posted
- 25 Mar 2016 (estimated)
- Last update posted
- 13 Apr 2023
- Conditions
- Adult Growth Hormone Deficiency (AGHD)
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2016201720182019
- Ph 2Terminated
Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in Adult Growth Hormone Deficiency (AGHD)
NCT0271999011 Feb 2016 to 11 Jan 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (GHD).
Interventions
- somavaratanDrug
Arms1
Experimental
Somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly in adult participants with GHD
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Participants With Adverse Events (AEs)
Time frame · From first dose of study drug up to approximately 2 years
Registry description
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'.
Secondary outcomes(6)
Average Dose Level During Titration/Maintenance
Time frame · Up to Month 12
Registry description
Total average dose received by a participant during titration/maintenance has been reported.
Number of Participants With Dose Adjustments
Time frame · Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Registry description
The number of participants with a dose adjustment (titrated up/down) at each month are summarized.
Number of Participants Who Were Anti-drug Antibody (ADA) Positive
Time frame · Up to approximately 2 years
Number of Participants With Positive Neutralizing Antibodies (NABs)
Time frame · Up to approximately 2 years
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Time frame · 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
Registry description
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.
Mean Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) SDS During Maintenance Period
Time frame · Baseline up to Month 12
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeMean· Up to Month 12
Average Dose Level During Titration/Maintenance
| Group | Value (mg) | Spread |
|---|---|---|
| Somavaratan | 41.60 | 47.398 |
Secondary outcomeCount of participants· Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Number of Participants With Dose Adjustments
| Group | Value (Participants) |
|---|---|
| Somavaratan | 11 |
Secondary outcomeCount of participants· Up to approximately 2 years
Number of Participants Who Were Anti-drug Antibody (ADA) Positive
| Group | Value (Participants) |
|---|---|
| Somavaratan | 22 |
Secondary outcomeCount of participants· Up to approximately 2 years
Number of Participants With Positive Neutralizing Antibodies (NABs)
| Group | Value (Participants) |
|---|---|
| Somavaratan | 15 |
Secondary outcomeMean· 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
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
| Group | Value (SDS) | Spread |
|---|---|---|
| Somavaratan | 0.76 | 0.639 |
Secondary outcome· Baseline up to Month 12
Mean Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) SDS During Maintenance Period
| Group | Value |
|---|---|
| Somavaratan | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| SomavaratanParticipants received once-monthly SC somavaratan per Protocol Version 1.0. The dosing regimen was then modified in Protocol Version 2.0 to twice-monthly SC somavaratan. Doses were titrated to each participant's individual IGF-I responses based on the IGF-I level 7 days postdose until a maintenance dose was achieved. Maintenance dose was defined as an IGF-I value between 0 and 2.0 SDS for two consecutive 7-day postdose time points (Day 8, peak level). Participants who received somavaratan once-monthly in this study or in a previous somavaratan study (15VR7), had their dose decreased by half (minimum dose of 20 mg, 40 mg for women on estrogen, rounded down to the nearest even number) and were titrated based on IGF-I level at Day 8. New participants enrolling in this study received a starting dose of 20 mg twice-monthly (40 mg for women on estrogen) and were titrated based on IGF-I level at Day 8. Maintenance doses were adjusted further based on PD data at the discretion of the Investigator or Medical Monitor. The maximum allowable dose of somavaratan was 250.0 mg. | 0 / 36 | 5 / 36 | 30 / 36 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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