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Trial record 1 of 1 for:    NCT02879747
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Individualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children (MAINTENANCE)

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ClinicalTrials.gov Identifier: NCT02879747
Recruitment Status : Completed
First Posted : August 26, 2016
Results First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Göteborg University

Tracking Information
First Submitted Date  ICMJE August 10, 2016
First Posted Date  ICMJE August 26, 2016
Results First Submitted Date  ICMJE November 21, 2018
Results First Posted Date  ICMJE April 30, 2019
Last Update Posted Date April 30, 2019
Actual Study Start Date  ICMJE December 2003
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
The Proportion of Children Maintaining Normal Growth Velocity [ Time Frame: twelve months ]
The proportion of children in the intervention 1 group (=reduced dose) that maintained an individual ΔheightSDS within ±0.3 during the first year of the Maintenance trial, compared to the proportion of children in the intervention 2 group (non-reduced dose)
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
Growth velocity (defined as delta height SDS) from start to first year on adapted GH dosage in GH treated prepubertal children who have previously responded to GH treatment with fulfilled catch up growth. [ Time Frame: 9 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • IGF-I [ Time Frame: start of study to two years after start in the trial ]
    Delta Insulin-like growth factor-I (24 months after start compared to start of study) expressed as ng/ml and converted to standard deviation scores (SDS) to adjust for gender and age. A standard deviation score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A mean value within +-0.5 SDS and a range within +-1.0 SDS is a favorable outcome.
  • Height SDS at Start of Puberty [ Time Frame: 1-7 years in the trial ]
    Height at start of puberty measured as cm and expressed as standard deviation score (SDS) to adjust for age and gender
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
Changes in IGF-I and IGFBP-3 [ Time Frame: start of study to one year after start ]
change in insulin-like growth factor I and its binding protein
Current Other Pre-specified Outcome Measures
 (submitted: April 8, 2019)
Changes in Height [ Time Frame: start of study to two years after start in the trial ]
Changes in height standard deviation scores (SDS) (calculated as height in cm at start converted to SDS and height in cm after two years in the trial converted to SDS)
Original Other Pre-specified Outcome Measures
 (submitted: August 22, 2016)
  • Changes in body composition [ Time Frame: start of study to one year after start ]
    Changes in muscle mass, bone mass and fat mass with DEXA technique
  • Quality of life [ Time Frame: start of study to one year after start ]
    measures of quality of Life with several validated questionaires
 
Descriptive Information
Brief Title  ICMJE Individualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children
Official Title  ICMJE Individualizing the Dose of Growth Hormone (GH) to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children Within TR 98-0198-003
Brief Summary The objective was to study whether normal growth velocity can be maintained with adapted GH dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled catch up growth (=difference to target height reached, less than - 0.6 SDS).
Detailed Description The aim of the trial is to study the effect of adapted GH treatment in order to find an individualized GH dose maintaining normal growth velocity close to target height SDS and normal metabolism after fulfilled catch up growth in prepubertal children treated with individual doses of GH within the trial 98-0198-003 (1). The overall aim is to find for the individual the lowest effective GH dose during maintenance period, maintaining normal growth velocity and metabolism, i.e. a satisfactory biological active dose.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Short Stature
Intervention  ICMJE Drug: Genotropin
Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth
Study Arms  ICMJE
  • Active Comparator: Interventional
    Unchanged dose Genotropin
    Intervention: Drug: Genotropin
  • Active Comparator: Interventional 2
    reduced dose 50% Genotropin
    Intervention: Drug: Genotropin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2016)
99
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participated in the 'GH-dose catch-up study' 98- 0198-003.
  • Midparental height reached (difference less than 0.6 SDS)
  • Prepubertal at start of the study (girls =B 1, boys: testes :<; 3ml).
  • Signed written informed consent from the patient's parents (and the child if old enough)

Exclusion Criteria:

  • Disease affecting growth other than correctly treated hypothyroidism.
  • Incapable of following the study protocol (i.e. bad compliance in the previous study).
  • Puberty (> breast stage 2, or testes > 4ml).
  • Poor compliance.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02879747
Other Study ID Numbers  ICMJE NRA 6280003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Göteborg University
Study Sponsor  ICMJE Göteborg University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Berit Kriström, MD Umeå University Hospital
Principal Investigator: Nils-Östen Nilsson, MD Halmstad Department of Pediatrics
Principal Investigator: Maria Halldin, MD Uppsala University Hospital
Principal Investigator: Sten Ivarsson, MD, Prof Malmö Academic Hospital
Principal Investigator: Kerstin Albertsson-Wikland, MD, prof Gothenburg University, Departments of pediatrics
PRS Account Göteborg University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP