Trial · Observational

TerminatedPhase not statedResults postedRegistry data

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

NCTNCT01243892Other idL4917gOther idML01311

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: The study was closed due to the slow enrollment rate.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase not stated
Enrollment: 18 participants (actual)
Sponsor: Genentech, Inc. · Industry
Design: Not stated
Countries: 1 country
United States
Start: Nov 2010
Primary completion: Aug 2011
Completion: Aug 2011
First posted: 19 Nov 2010 (estimated)
Last update posted: 1 Dec 2016 (estimated)
Conditions: Growth Hormone Deficiency

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201020112012

Ph –
A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device
NCT01243892
Nov 2010 to Aug 2011
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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) using NuSpin device compared to historical controls from the national cooperative growth study (NCGS).

Interventions

NuSpinDevice
SomatropinDrug

Arms2

Other
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.
Other
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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)
Registry description
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.

Secondary outcomes(2)

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)
Registry description
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.
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)
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· Baseline up to Month 24 (Year 2)

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

Group	Value
IGHD Participants	not posted
ISS Participants	not posted

Secondary and other outcome results(2)

Secondary outcome· Baseline up to Month 12 (Year 1)

Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device for First Year of Treatment

Group	Value
IGHD Participants	not posted
ISS Participants	not posted

Secondary outcome· Month 12 to Month 24 (Year 1 to Year 2)

Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device During the Second Year of Therapy

Group	Value
IGHD Participants	not posted
ISS Participants	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
IGHD ParticipantsIGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.	–	1 / 15	0 / 15
ISS ParticipantsISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.	–	0 / 3	1 / 3

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 2 Years up to 14 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 Exclusion Criteria: * 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

PepBank is a research reference. Talk to a doctor before you use any peptide.