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

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Brief Title

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

Official Title

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

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



Study Type

Observational


Primary Outcome

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

Secondary Outcome

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

Condition

Growth Hormone Deficiency

Intervention

NuSpin

Study Arms / Comparison Groups

 Cohort 1: IGHD participants
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

18

Start Date

November 2010

Completion Date

August 2011

Primary Completion Date

August 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Bone age less than or equal to (] 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
      

Gender

All

Ages

2 Years - 14 Years

Accepts Healthy Volunteers

No

Contacts

D. Aaron Davis, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01243892

Organization ID

L4917g

Secondary IDs

ML01311

Responsible Party

Sponsor

Study Sponsor

Genentech, Inc.


Study Sponsor

D. Aaron Davis, M.D., Study Director, Genentech, Inc.


Verification Date

October 2016