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

October 9, 2009 updated by: Ambrx, Inc.

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).

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2

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

  • Hungary
      • Budapest, Hungary
        • Accelsiors CRO and Consultancy Services

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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
low dose
Drug: ARX201
Reconstituted lyophilized drug product at 2.5 mg/wk; 3 periods over six months.
Drug: ARX201
Reconstituted lyophilized drug product at 5.0 mg/wk; 3 periods over six months.
Drug: ARX201
Reconstituted lyophilized drug product at 10.0 mg/wk; 3 periods over six months.
Active Comparator: 2
Medium dose
Drug: ARX201
Reconstituted lyophilized drug product at 2.5 mg/wk; 3 periods over six months.
Drug: ARX201
Reconstituted lyophilized drug product at 5.0 mg/wk; 3 periods over six months.
Drug: ARX201
Reconstituted lyophilized drug product at 10.0 mg/wk; 3 periods over six months.
Active Comparator: 3
High Dose
Drug: ARX201
Reconstituted lyophilized drug product at 2.5 mg/wk; 3 periods over six months.
Drug: ARX201
Reconstituted lyophilized drug product at 5.0 mg/wk; 3 periods over six months.
Drug: ARX201
Reconstituted lyophilized drug product at 10.0 mg/wk; 3 periods over six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Temporal profiling of circulating IGF-1 levels.
Time Frame: 3 period
3 period

Secondary Outcome Measures

Outcome Measure
Time Frame
Body composition measurements at start of study and end of study
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Ambrx, Inc.

Collaborators

Merck Serono International SA

Investigators

  • Study Director: Mihaly Juhasz, MD, Accelsiors CRO & Consultancy Services

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

July 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

October 22, 2008

First Submitted That Met QC Criteria

October 22, 2008

First Posted (Estimate)

October 23, 2008

Study Record Updates

Last Update Posted (Estimate)

October 12, 2009

Last Update Submitted That Met QC Criteria

October 9, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-ARX201-701
  • EudraCT: 2007-001746-40

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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