NCT00778518

Brief Summary

Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 12, 2009

Status Verified

October 1, 2009

Enrollment Period

1.3 years

First QC Date

October 22, 2008

Last Update Submit

October 9, 2009

Conditions

Growth Hormone Deficiency

Keywords

growth hormonegrowth hormone deficiencyGHDPEGpegylatedIGF-1

Outcome Measures

Primary Outcomes (1)

  • Temporal profiling of circulating IGF-1 levels.

    3 period

Secondary Outcomes (1)

  • Body composition measurements at start of study and end of study

    6 months

Study Arms (3)

1

ACTIVE COMPARATOR

low dose

Drug: ARX201

2

ACTIVE COMPARATOR

Medium dose

Drug: ARX201

3

ACTIVE COMPARATOR

High Dose

Drug: ARX201

Interventions

ARX201DRUG

Reconstituted lyophilized drug product at 2.5 mg/wk; 3 periods over six months.

1

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • GHD of childhood onset
  • completed growth
  • IGF-1 \<=2SDS
  • rhGH treatment naive
  • hGH levels below cut-off

You may not qualify if:

  • History of malignancy or intracranial tumors
  • ECG abnormality
  • ICH
  • hepatic dysfunction
  • renal impairment
  • major medical conditions
  • inadequate T4
  • positive for HBV, HCV, or HIV
  • alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Accelsiors CRO and Consultancy Services

Budapest, Hungary

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Mihaly Juhasz, MD

    Accelsiors CRO & Consultancy Services

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 23, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

October 12, 2009

Record last verified: 2009-10

Locations

HU(1)