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NCT Number: NCT00778518

Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).

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

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Accelsiors CRO and Consultancy Services

Budapest, Hungary

About this study

The primary objective of this study is to evaluate the safety, tolerability and pharmacodynamic response of three different ARX201 doses (PEG-ahGH) when administered repeatedly to young adult patients with childhood onset growth hormone deficiency (GHD).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-30 years old
  • GHD of childhood onset
  • completed growth
  • IGF-1 <=2SDS
  • rhGH treatment naive
  • hGH levels below cut-off

Exclusion criteria

  • 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

Treatment and study plan

ARX201

Drug

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

Primary outcomes

  1. Temporal profiling of circulating IGF-1 levels.

    Time frame: 3 period

Secondary outcomes

  1. Body composition measurements at start of study and end of study

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Ambrx, Inc.

Industry

Collaborators

  • Merck Serono International SA

Registry information

Official study title

Phase IIb Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 23, 2008
Registry last updated
Oct 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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