Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658

August 8, 2023 updated by: Novo Nordisk A/S

Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 Trial

This trial is conducted in Europe. The aim of this trial is to obtain the PTPN11 mutation status and investigate the impact of the PTPN11 mutation status on the effect of somatropin (Norditropin®) by use of data obtained in the GHNOO-1658 trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 3

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

  • Sweden
      • Göteborg, Sweden, 416 85

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participation in the GHNOO-1658 trial
  • Subject has completed genetic testing of PTPN11 mutation

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose 33 mcg/kg/day
Drug: somatropin
Results from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658.
Experimental: High dose 66 mcg/kg/day
Drug: somatropin
Results from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in height SDS (Standard Deviation Score) (referenced to normal population)
Time Frame: From baseline until final height is reached
From baseline until final height is reached

Secondary Outcome Measures

Outcome Measure
Time Frame
Final height SDS (referenced to normal population)
Time Frame: From baseline until final height is reached
From baseline until final height is reached
Final height SDS (referenced to Noonan population)
Time Frame: From baseline until final height is reached
From baseline until final height is reached
Change in height SDS (referenced to Noonan population)
Time Frame: From baseline until final height is reached
From baseline until final height is reached
Number of subjects with final height SDS above - 2SDS (reference to normal population)
Time Frame: When final height is reached
When final height is reached
Proportion of subjects with final height SDS above - 2SDS (reference to normal population)
Time Frame: When final height is reached
When final height is reached
Adverse events
Time Frame: From baseline until final height is reached
From baseline until final height is reached

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

September 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

January 2, 2012

First Submitted That Met QC Criteria

February 8, 2012

First Posted (Estimated)

February 9, 2012

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHNOO-3680
  • 2008-004535-38 (EudraCT Number)

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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