Growth Hormone DeficiencyPhase 1NCT01359488
VRS-317 in Adult Subjects With Growth Hormone Deficiency
A Phase 1 study testing VRS-317 in people with Growth Hormone Deficiency, run by Versartis Inc. at 1 site in United States.
Trial summary
The purpose of this research study is to determine the safety and tolerability of up to five doses of VRS-317 in Adult Growth Hormone Deficient patients. Patients will be evaluated for evidence of activity of VRS-317 by measurement of changes from baseline in insulin-like growth factor-1 (IGF-I) and binding protein… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- VRS-317
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25 to 65 years
- Negative serum pregnancy test for females of childbearing potential
- Documented confirmation (medical history) of GHD during adulthood by one or more GH stimulation test
- If taking hormone replacement therapy other than rhGH, patient must be on a stable course of treatment for 2 months prior to enrollment
- Pituitary disorder associated with GHD has been clinically stable for at least 6 months
- Currently receiving daily recombinant human growth hormone (rhGH) injections for treatment of GHD for a minimum of 28 days
- Willing and able to give informed consent
- Within one year from enrollment, normal result from screening including: mammogram (women), pap smear (women over 25), Men over 50 years old: digital rectal exam
Who cannot join
- Subjects who have received systemic treatment for any bacterial, viral or fungal infection within 30 days of the first study drug dosing (prophylactic acyclovir for HSV is permitted)
- Subjects with documented history of diabetes mellitus or inadequate glucose control as defined by fasting plasma glucose level of greater than 126 mg/dL (7 mM) or HbA1c of ≥ 6.5% at screening
- Subjects with untreated adrenal insufficiency.
- Free thyroxine below normal reference range or TSH above normal reference range
- Current use of oral or inhaled steroids except for physiological maintenance doses of oral glucocorticoids in patients with multiple pituitary hormone deficiencies
- Women using oral estrogens, including birth control pills, during study (transdermal estrogen patches are allowed)
Show all 17Show fewer
- Current significant cardiovascular, cerebrovascular, pulmonary, neurological (not related to GHD), renal or hepatobillary disease
- Presence of retinopathy or papillaedema
- Documented history of persistent (unresolved without medical intervention) or recurring migraines, edema, arthralgia (not related to osteoarthritis), or nausea
- History of drug or alcohol abuse.
- Must not have documented prior history of HIV, HBV or HCV infection(testing not required)
- Prior history of cancer excluding adequately treated non-melanoma skin cancers or adequately treated in situ carcinoma of the cervix
- Women who are pregnant or breastfeeding
- Unwilling to use two effective birth control methods until Day 60 of Treatment Phase
- Pre-existing antibodies to human growth hormone at time of screening (screening samples must be below pre-specified cut-off for positive anti-hGH antibody titer)
- Treatment with an investigational drug within past 30 days prior to screening
- Unable to comply with requirements of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78229
About this study
Official title: A Blinded Placebo Controlled Single Ascending Dose Phase 1 for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Subcutaneous Administration of VRS-317 in Adults With Growth Hormone Deficiency
The purpose of this research study is to determine the safety and tolerability of up to five doses of VRS-317 in Adult Growth Hormone Deficient patients.
- Patients will be evaluated for evidence of activity of VRS-317 by measurement of changes from baseline in insulin-like growth factor-1 (IGF-I) and binding protein (IGFBP-3), and bone turnover (bone alkaline phosphatase)
- Descriptive pharmacokinetic (PK) and pharmacodynamic (PD) parameters (IGF-I and IGFBP-3) will be determined by standard model independent methods based on the plasma concentration-time data of each subject. These parameters include: Cmax, Tmax, AUCavg, AUC0-inf, and t1/2.
- The purpose is to determine the appropriate dose of VRS-317 to maintain a normal range (for appropriate age/gender) for IGF-I levels in adult patients for up to one month after administration of a single dose
Read the detailed description
The study is a placebo controlled single ascending dose (SAD) study in adult GHD patients currently receiving daily rhGH therapy. After screening patients are withdrawn from daily rhGH therapy for a minimum of 7 days (maximum of 60 days) prior to randomization for treatment. Patients will be randomised within a treatment group that is currently being enrolled once the patient has passed the pre-dose screening criteria.
Documented confirmation (medical history) of GHD during adulthood by a minimum of one or more GH stimulation tests is required such as:
- insulin tolerance test (ITT; peak hGH ≤ 5.0 ng/mL),
- arginine alone (peak hGH ≤ 0.4 ng/mL);
- arginine + growth-hormone-releasing hormone* (see below);
- or glucagon stimulation test (peak hGH ≤ 3.0 ng/mL) OR
- at least 3 other pituitary hormone deficiencies and a low IGF-I for age/gender appropriate normal range
Each patient will be randomised to receive either the investigational product, VRS-317 (Cohorts A-E), or placebo (Cohort F) in a 4:1 ratio.
Subjects will be monitored for safety throughout their participation in the study. To ensure patient safety, two patients (1 active, 1 placebo) in the first treatment group, one from Cohort A and one from Cohort F1, will be dosed in a blinded manner and monitored for 48 hr prior to dosing the remaining 8 patients. The 8 remaining patients will be blinded and randomized to the first treatment group. Vital signs, clinical lab values, adverse events (AEs) and concomitant medications (CMs) will be captured. AEs will be graded using the Common Terminology Criteria for Adverse Events (CTCAE v 4.0)1, and the Primary Dermal Irritation Scoring Scale; AEs will be coded using the MedDRA2 dictionary and CMs using the WHO Drug dictionary. Prior to escalating to a higher dose level, safety data will be reviewed by the principal investigator (PI), co-PIs, the Sponsor, and the medical monitor for any potential safety risk to subjects.
Patients will participate for a total of 83-215 days. A 7-60 day withdrawal phase (no daily rhGH therapy) is followed by receiving assigned doses on Day 1 of Treatment Phase, PK/PD and safety assessments for 30 days, and an additional 30 days of follow up.
Safety evaulations will be performed to assess safety including but not limited to:
- Physical examination
- Vital signs (including sitting/supine blood pressure)
- Laboratory tests: hematology, chemistry, urinalysis, and pregnancy testing (in women of child-bearing age)
- Adverse events and concomitant medications
- Glucose metabolism: Fasting and post-prandial plasma glucose and fasting insulin pre-study and at pre-scheduled timepoints during the study (per Assessment Table)
- Lipid profile will be assessed pre-study and at pre-scheduled timepoints during the study (per Assessment Table)
- Assessment for adrenal insufficiency prior to enrollment and at Day 30 (not performed on patients with documented history of adrenal insufficiency)
- Evaluation of injection site reactions
- Anti-VRS-317 antibody assay (pre-dose, Day 30 (end of study) and Day 60) last follow up visit
- Safety monitoring will continue for up to 60 days post-dose
- Conditions
- Growth Hormone Deficiency
- Being tested
- VRS-317
- Keywords
- Growth Hormone Deficiency, rhGH, hGH, Versartis, AGHD, Hormones, Hormone substitute, Endocrin System disease, Bone disease, Bone disease, developmental, Bone diseases, Musculoskeletal diseases, Bone diseases, endocrine, Metabolism diseases, Hypopituitarism, Pituitary disease, Hypothalmic disease, Brain disease, Growth Hormone Releasing Hormone, Hormone replacement therapy
- Medical subject headings
- Dwarfism, Pituitary, Bone Diseases, Bone Diseases, Developmental, Musculoskeletal Diseases, Bone Diseases, Endocrine, Hypopituitarism, Pituitary Diseases, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRS-317Drug
Also called Growth Hormone Deficiency, rhGH, hGH, AGHD
VRS-317 Single Dose
VRS-317Drug
Also called Growth Hormone Deficiency, rhGH, hGH, AGHD
VRS-317 Single Dose
VRS-317Drug
Also called Growth Hormone Deficiency, rhGH, hGH, AGHD
VRS-317 Single Dose
VRS-317Drug
Also called Arms:, Other Names:, Growth Hormone Deficiency, rhGH
VRS-317 Single dose
VRS-317Drug
Also called Growth Hormone Deficiency, rhGH, hGH, AGHD
VRS-317 Single dose
| Study group | Role | What they receive |
|---|---|---|
| VRS-317 Safety Arm 1 | Experimental | VRS-317 Single injection SC of dose level 1 (based on 90 kg patient)
Placebo Single SC injection Dose Volume matched to active treatment volume Receives: Drug: VRS-317 |
| VRS-317 Safety Arm 2 | Experimental | VRS-317 Single injection SC of dose level 2 (based on 90 kg patient)
Placebo Single SC injection Dose Volume matched to active treatment volume Receives: Drug: VRS-317 |
| VRS-317 Safety Arm 3 | Experimental | VRS-317 Single injection SC of dose level 3 (based on 90 kg patient)
Placebo Single SC injection Dose Volume matched to active treatment volume Receives: Drug: VRS-317 |
| VRS-317 Safety Arm 4 | Experimental | VRS-317 Two injections SC of dose level 4 (based on 90 kg patient)
Placebo Two SC injection Dose matched to treatment volume Receives: Drug: VRS-317 |
| VRS-317 Safety Arm 5 | Experimental | VRS-317 Two injections SC of dose level 5 (based on 90 kg patient)
Placebo Two SC injections Dose Volume matched to active treatment volume Receives: Drug: VRS-317 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of single dose of VRS-317
This study will evaluate the differences between VRS-317 dose levels and placebo for adverse events. Summaries will be provided for each dose cohort and for the combined dose cohorts including the number of patients with adverse events. All subjects who receive at least one dose of VRS-317 or placebo will be included in the safety analysis. Summaries of all adverse events (AEs)and serious adverse events (SAEs)will be classified according to severity and relationship to study drug.
Measured: 30 days
Secondary outcomes (1)
Determine the pharmacokinetic (PK) profile of VRS-317 administered SC
Parameters
- Pharmacokinetic (PK)parameters are determined from WinNonLin analysis using a one compartment model. [Timeframe = 30 days] Cmax Tmax AUCavg AUC0-inf t1/2
- Parmacodynamic (PD)parameters are determined from WinNonLin analysis using a one compartment model. [Timeframe = 30 days] Cmax Tmax AUCavg AUC0-inf t1/2
- IGF-I and IGFBP-3 values compared against baseline parameters and parameters obtained from daily rhGH treatment. [Timeframe = 90 days]
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versartis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Kipnes, MD, Principal investigator, Diabetes and Glandular Disease Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359488
- Sponsor's protocol ID
- VRS-317 1a
- Status last verified
- Jul 2012
- First submitted
- 13 May 2011
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Yuen KC, Conway GS, Popovic V, Merriam GR, Bailey T, Hamrahian AH, Biller BM, Kipnes M, Moore JA, Humphriss E, Bright GM, Cleland JL. A long-acting human growth hormone with delayed clearance (VRS-317): results of a double-blind, placebo-controlled, single ascending dose study in growth hormone-deficient adults. J Clin Endocrinol Metab. 2013 Jun;98(6):2595-603. doi: 10.1210/jc.2013-1437. Epub 2013 Apr 12.
PubMed 23585663
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded Placebo Controlled Single Ascending Dose Phase 1 for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Subcutaneous Administration of VRS-317 in Adults With Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT01359488
- Acronym / sponsor ID
- VRS-317 1a
- Conditions
- Growth Hormone Deficiency
- Keywords
- Growth Hormone Deficiency, rhGH, hGH, Versartis, AGHD, Hormones, Hormone substitute, Endocrin System disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Versartis Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine the safety and tolerability of up to five doses of VRS-317 in Adult Growth Hormone Deficient patients.
- Patients will be evaluated for evidence of activity of VRS-317 by measurement of changes from baseline in insulin-like growth factor-1 (IGF-I) and binding protein (IGFBP-3), and bone turnover (bone alkaline phosphatase)
- Descriptive pharmacokinetic (PK) and pharmacodynamic (PD) parameters (IGF-I and IGFBP-3) will be determined by standard model independent methods based on the plasma concentration-time data of each subject. These parameters include: Cmax, Tmax, AUCavg, AUC0-inf, and t1/2.
- The purpose is to determine the appropriate dose of VRS-317 to maintain a normal range (for appropriate age/gender) for IGF-I levels in adult patients for up to one month after administration of a single dose
Detailed description
The study is a placebo controlled single ascending dose (SAD) study in adult GHD patients currently receiving daily rhGH therapy. After screening patients are withdrawn from daily rhGH therapy for a minimum of 7 days (maximum of 60 days) prior to randomization for treatment. Patients will be randomised within a treatment group that is currently being enrolled once the patient has passed the pre-dose screening criteria.
Documented confirmation (medical history) of GHD during adulthood by a minimum of one or more GH stimulation tests is required such as:
- insulin tolerance test (ITT; peak hGH ≤ 5.0 ng/mL),
- arginine alone (peak hGH ≤ 0.4 ng/mL);
- arginine + growth-hormone-releasing hormone* (see below);
- or glucagon stimulation test (peak hGH ≤ 3.0 ng/mL) OR
- at least 3 other pituitary hormone deficiencies and a low IGF-I for age/gender appropriate normal range
Each patient will be randomised to receive either the investigational product, VRS-317 (Cohorts A-E), or placebo (Cohort F) in a 4:1 ratio.
Subjects will be monitored for safety throughout their participation in the study. To ensure patient safety, two patients (1 active, 1 placebo) in the first treatment group, one from Cohort A and one from Cohort F1, will be dosed in a blinded manner and monitored for 48 hr prior to dosing the remaining 8 patients. The 8 remaining patients will be blinded and randomized to the first treatment group. Vital signs, clinical lab values, adverse events (AEs) and concomitant medications (CMs) will be captured. AEs will be graded using the Common Terminology Criteria for Adverse Events (CTCAE v 4.0)1, and the Primary Dermal Irritation Scoring Scale; AEs will be coded using the MedDRA2 dictionary and CMs using the WHO Drug dictionary. Prior to escalating to a higher dose level, safety data will be reviewed by the principal investigator (PI), co-PIs, the Sponsor, and the medical monitor for any potential safety risk to subjects.
Patients will participate for a total of 83-215 days. A 7-60 day withdrawal phase (no daily rhGH therapy) is followed by receiving assigned doses on Day 1 of Treatment Phase, PK/PD and safety assessments for 30 days, and an additional 30 days of follow up.
Safety evaulations will be performed to assess safety including but not limited to:
- Physical examination
- Vital signs (including sitting/supine blood pressure)
- Laboratory tests: hematology, chemistry, urinalysis, and pregnancy testing (in women of child-bearing age)
- Adverse events and concomitant medications
- Glucose metabolism: Fasting and post-prandial plasma glucose and fasting insulin pre-study and at pre-scheduled timepoints during the study (per Assessment Table)
- Lipid profile will be assessed pre-study and at pre-scheduled timepoints during the study (per Assessment Table)
- Assessment for adrenal insufficiency prior to enrollment and at Day 30 (not performed on patients with documented history of adrenal insufficiency)
- Evaluation of injection site reactions
- Anti-VRS-317 antibody assay (pre-dose, Day 30 (end of study) and Day 60) last follow up visit
- Safety monitoring will continue for up to 60 days post-dose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| VRS-317 Safety Arm 1 | Experimental | Drug: VRS-317VRS-317 Single injection SC of dose level 1 (based on 90 kg patient) Placebo Single SC injection Dose Volume matched to active treatment volume |
| VRS-317 Safety Arm 2 | Experimental | Drug: VRS-317VRS-317 Single injection SC of dose level 2 (based on 90 kg patient) Placebo Single SC injection Dose Volume matched to active treatment volume |
| VRS-317 Safety Arm 3 | Experimental | Drug: VRS-317VRS-317 Single injection SC of dose level 3 (based on 90 kg patient) Placebo Single SC injection Dose Volume matched to active treatment volume |
| VRS-317 Safety Arm 4 | Experimental | Drug: VRS-317VRS-317 Two injections SC of dose level 4 (based on 90 kg patient) Placebo Two SC injection Dose matched to treatment volume |
| VRS-317 Safety Arm 5 | Experimental | Drug: VRS-317VRS-317 Two injections SC of dose level 5 (based on 90 kg patient) Placebo Two SC injections Dose Volume matched to active treatment volume |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 25 to 65 years
- Negative serum pregnancy test for females of childbearing potential
- Documented confirmation (medical history) of GHD during adulthood by one or more GH stimulation test
- If taking hormone replacement therapy other than rhGH, patient must be on a stable course of treatment for 2 months prior to enrollment
- Pituitary disorder associated with GHD has been clinically stable for at least 6 months
Key exclusion criteria (17 listed)
- Subjects who have received systemic treatment for any bacterial, viral or fungal infection within 30 days of the first study drug dosing (prophylactic acyclovir for HSV is permitted)
- Subjects with documented history of diabetes mellitus or inadequate glucose control as defined by fasting plasma glucose level of greater than 126 mg/dL (7 mM) or HbA1c of ≥ 6.5% at screening
- Subjects with untreated adrenal insufficiency.
- Free thyroxine below normal reference range or TSH above normal reference range
- Current use of oral or inhaled steroids except for physiological maintenance doses of oral glucocorticoids in patients with multiple pituitary hormone deficiencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRS-317Also: Growth Hormone Deficiency, rhGH, hGH, AGHDVRS-317 Single Dose | Drug | VRS-317 Safety Arm 1 |
| VRS-317Also: Growth Hormone Deficiency, rhGH, hGH, AGHDVRS-317 Single Dose | Drug | VRS-317 Safety Arm 2 |
| VRS-317Also: Growth Hormone Deficiency, rhGH, hGH, AGHDVRS-317 Single Dose | Drug | VRS-317 Safety Arm 3 |
| VRS-317Also: Arms:, Other Names:, Growth Hormone Deficiency, rhGHVRS-317 Single dose | Drug | VRS-317 Safety Arm 4 |
| VRS-317Also: Growth Hormone Deficiency, rhGH, hGH, AGHDVRS-317 Single dose | Drug | VRS-317 Safety Arm 5 |
Primary outcome
Safety and Tolerability of single dose of VRS-317
Time frame: 30 days
This study will evaluate the differences between VRS-317 dose levels and placebo for adverse events. Summaries will be provided for each dose cohort and for the combined dose cohorts including the number of patients with adverse events. All subjects who receive at least one dose of VRS-317 or placebo will be included in the safety analysis. Summaries of all adverse events (AEs)and serious adverse events (SAEs)will be classified according to severity and relationship to study drug.
1 secondary outcome
Determine the pharmacokinetic (PK) profile of VRS-317 administered SC
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2012.
- Derived from this study: PubMed 23585663Yuen KC, Conway GS, Popovic V, Merriam GR, Bailey T, Hamrahian AH, Biller BM, Kipnes M, Moore JA, Humphriss E, Bright GM, Cleland JL. A long-acting human growth hormone with delayed clearance (VRS-317): results of a double-blind, placebo-controlled, single ascending dose study in growth hormone-deficient adults. J Clin Endocrinol Metab. 2013 Jun;98(6):2595-603. doi: 10.1210/jc.2013-1437. Epub 2013 Apr 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Kipnes, MD principal investigator
Diabetes and Glandular Disease Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRS-317 in people with Growth Hormone Deficiency, run by Versartis Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of single dose of VRS-317 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01359488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2012.