NCT03274973

Brief Summary

Assessment of long-term effectiveness of ZOMACTON in treatment of Growth Hormone Deficiency or growth retardation due to Ullrich-Turner Syndrome and assessment of compliance and adherence, optionally with the aid of an electronic app or patient diary.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

May 14, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

August 29, 2017

Last Update Submit

December 11, 2018

Conditions

Growth Disorders

Outcome Measures

Primary Outcomes (1)

  • Linear growth (change in height)

    Change in height defined as the change of the standard deviation score of body height vs. baseline

    Over the first 12 months (month 0, 3, 6, 9 and 12)

Study Arms (1)

Zomacton

Drug: Zomacton

Interventions

ZomactonDRUG

Injection

Zomacton

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric outpatient clinic

You may qualify if:

  • Pediatric patients (\< 18 years) with growth hormone deficiency or growth retardation due to Ullrich-Turner-Syndrome
  • Patients already receiving or who have been prescribed Zomacton® de novo according to its German label; the decision to prescribe Zomacton® was made independently from participation and prior to enrollment in this study.
  • Patient and their parents (or legal representatives) who are willing and able to provide signed informed consent for use of their personal data.

You may not qualify if:

  • Participation in an interventional clinical study within the last 30 days prior to baseline visit or during the follow-up period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik fuer Allgemeine Paediatrie der Christian-Albrechts-Universitaet zu Kiel (there might be other sites in this country)

Kiel, 24105, Germany

Location

MeSH Terms

Conditions

Growth Disorders

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Compliance

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 7, 2017

Study Start

May 14, 2018

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

December 13, 2018

Record last verified: 2018-12

Locations

DE(1)