Growth Hormone DeficiencyNCT01243892

A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device

An observational study of Growth Hormone Deficiency, run by Genentech, Inc. at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is a Phase IV, open label, case-controlled, observational study to evaluate the age-adjusted cumulative height velocity in pre-pubertal isolated growth hormone deficient (IGHD) and idiopathic short stature (ISS) participants receiving daily doses of somatropin (recombinant human growth hormone [rhGH]; Nutropin)… Read more about this study

Who is it for?: Ages 2 to 14 years
Conditions the study is for: Growth Hormone Deficiency
What is being tested?: NuSpin and Somatropin
Type of treatment: Injection or infusion, Medical device
How many people: 18 participants
Where: 14 sitesUnited States
Study dates: Nov 2010to Aug 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 2 to 14 years
All sexes
No healthy volunteers
Child

Study population: Somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS

Who may be able to join

Bone age less than or equal to (</=) 8 years (females) or </= 10 years (males) as determined by x-ray of the left hand and wrist obtained within six months before enrollment
Prepubertal males and females by physical exam
Naive to rhGH therapy
Diagnosis of IGHD or ISS by standard pharmacologic testing and no other discernable etiology for short stature
Height standard deviation score (Ht SDS) </= -1.5 (</= 5th percentile) for IGHD participants; Ht SDS </= -2.25 (</= 1.2 percentile) for ISS participants

Who cannot join

Short stature etiologies other than IGHD or ISS
Participants receiving chronic corticosteroid therapy (greater than [>] 3 months) for other medical conditions
Participants with active malignancy or any other condition that the investigator believes would pose a significant hazard to the participant if rhGH were initiated
Females with turner syndrome
Any previous rhGH treatment
Participation in another simultaneous medical investigation or trial
Pediatric participants with closed epiphyses
Participants prescribed rhGH doses outside the variance of NCGS control participant dosing

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Study site
Atlanta, Georgia, 30342
Study site
Birmingham, Alabama, 35233
Study site
Columbus, Ohio, 43235
Study site
Greenwood Village, Colorado, 80111
Study site
Knoxville, Tennessee, 37916
Study site
Minneapolis, Minnesota, 55455
Study site
Mount Kisco, New York, 10549
Study site
New Rochelle, New York, 10801
Study site
Palm Bay, Florida, 32905
Study site
Pembrook Pines, Florida, 33028
Study site
Sacramento, California, 95819
Study site
San Diego, California, 92123
Study site
Scottsdale, Arizona, 85258
Study site
Wheaton, Illinois, 60187

Other trials in United States

About this study

Official title: A Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin®

Conditions: Growth Hormone Deficiency
Being tested: NuSpin, Somatropin
Medical subject headings: Dwarfism, Pituitary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NuSpinDevice
Device for administration of doses of somatropin.
SomatropinDrug
Also called Nutropin AQ (Somatropin [DNA Origin] injection)
Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.

Study groups in NCT01243892
Study group	Role	What they receive
Cohort 1: IGHD participants		Isolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid [DNA] origin) (recombinant human growth hormone [rhGH]) using the NuSpin device, will be observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen will be as per treating physician's discretion, the study protocol does not enforce or specify any treatment regimen. Receives: Device: NuSpin; Drug: Somatropin
Cohort 2: ISS participants		Idiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, will be observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen will be as per treating physician's discretion, the study protocol does not enforce or specify any treatment regimen. Receives: Device: NuSpin; Drug: Somatropin

What is being measured

The primary outcome is the main question the study is designed to answer.

Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment
The annualized height velocity (cm per year [cm/yr]) over 2 years was calculated as: [(height in cm at t24 minus (-) height in cm at t0) divided by (date at t24 - date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t24 is the 2-year measurement visit.
Measured: Baseline up to Month 24 (Year 2)

Secondary outcomes (2)

Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device for First Year of Treatment
The annualized height velocity (cm/yr) after 1 year was calculated as: [(height in cm at t12 - height in cm at t0) divided by (date at t12 - date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t12 is the 1-year measurement visit.
Measured: Baseline up to Month 12 (Year 1)
Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device During the Second Year of Therapy
The annualized height velocity (cm/yr) for second year was calculated as: [(height in cm at t24 - height in cm at t12) divided by (date at t24 - date at t12)] multiplied by 365.25, where, t12 is the 1-year measurement visit and t24 is the 2-year measurement visit.
Measured: Month 12 to Month 24 (Year 1 to Year 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Aug 2011

First posted19 Nov 2010 (estimated)
Study startNov 2010
Primary completionAug 2011
Study completionAug 2011

Why it stopped: The study was closed due to the slow enrollment rate.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
More trials run by Genentech, Inc.The sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01243892
Sponsor's protocol ID: L4917g
Other IDs: ML01311
Status last verified: Oct 2016
First submitted: 17 Nov 2010
Last updated: 1 Dec 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age

All Growth Hormone Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin®
ClinicalTrials.gov ID: NCT01243892
Acronym / sponsor ID: L4917g
Conditions: Growth Hormone Deficiency
Study type: Observational
Recruitment status: TerminatedReason stopped: The study was closed due to the slow enrollment rate.
Enrolment: 18 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 19 Nov 2010 (estimated)
Results: Posted 1 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Cohort 1: IGHD participants	–	Device: NuSpin, Drug: SomatropinIsolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid [DNA] origin) (recombinant human growth hormone [rhGH]) using the NuSpin device, will be observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen will be as per treating physician's discretion, the study protocol does not enforce or specify any treatment regimen.
Cohort 2: ISS participants	–	Device: NuSpin, Drug: SomatropinIdiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, will be observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen will be as per treating physician's discretion, the study protocol does not enforce or specify any treatment regimen.

Who may qualify

Ages: 2 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS

Key inclusion criteria (5 listed)

Bone age less than or equal to (</=) 8 years (females) or </= 10 years (males) as determined by x-ray of the left hand and wrist obtained within six months before enrollment
Prepubertal males and females by physical exam
Naive to rhGH therapy
Diagnosis of IGHD or ISS by standard pharmacologic testing and no other discernable etiology for short stature
Height standard deviation score (Ht SDS) </= -1.5 (</= 5th percentile) for IGHD participants; Ht SDS </= -2.25 (</= 1.2 percentile) for ISS participants

Key exclusion criteria (8 listed)

Short stature etiologies other than IGHD or ISS
Participants receiving chronic corticosteroid therapy (greater than [>] 3 months) for other medical conditions
Participants with active malignancy or any other condition that the investigator believes would pose a significant hazard to the participant if rhGH were initiated
Females with turner syndrome
Any previous rhGH treatment

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
NuSpinDevice for administration of doses of somatropin.	Device	Cohort 1: IGHD participants, Cohort 2: ISS participants
SomatropinAlso: Nutropin AQ (Somatropin [DNA Origin] injection)Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.	Drug	Cohort 1: IGHD participants, Cohort 2: ISS participants

Primary outcome

Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment
Time frame: Baseline up to Month 24 (Year 2)
The annualized height velocity (cm per year [cm/yr]) over 2 years was calculated as: [(height in cm at t24 minus (-) height in cm at t0) divided by (date at t24 - date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t24 is the 2-year measurement visit.

2 secondary outcomes

Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device for First Year of Treatment
Time frame: Baseline up to Month 12 (Year 1)
Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device During the Second Year of Therapy
Time frame: Month 12 to Month 24 (Year 1 to Year 2)

Results and safety

Results posted to the registry on 1 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IGHD Participants	15	13
ISS Participants	3	3

Primary outcome: Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment

Time frame: Baseline up to Month 24 (Year 2)

Population analysed: Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to approximately 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IGHD Participants	1 of 15 (6.7%)	0 of 15 (0%)	Not reported
ISS Participants	0 of 3 (0%)	1 of 3 (33.3%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated prematurely due to slow enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Growth Hormone Deficiency

RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age

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.

D. Aaron Davis, M.D. study director

Genentech, Inc.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Growth Hormone Deficiency, run by Genentech, Inc. at 14 sites 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment (time frame: Baseline up to Month 24 (Year 2)). 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 NCT01243892.

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 1 Dec 2016.