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

October 7, 2016 updated by: Genentech, Inc.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: NuSpin
Device for administration of doses of somatropin.
Drug: Somatropin
Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.
Other Names:
  • Nutropin AQ (Somatropin [DNA Origin] injection)
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.
Device: NuSpin
Device for administration of doses of somatropin.
Drug: Somatropin
Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.
Other Names:
  • Nutropin AQ (Somatropin [DNA Origin] injection)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline up to Month 24 (Year 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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.
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)
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.
Month 12 to Month 24 (Year 1 to Year 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: D. Aaron Davis, M.D., Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • L4917g
  • ML01311 (Other Identifier: Hoffmann-La Roche)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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