MedTrace Logo

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

NCT00778518 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2009-10-12

No results posted yet for this study

Summary

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

Conditions

  • Growth Hormone Deficiency

Interventions

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.

Sponsors & Collaborators

  • Merck Serono International SA

    collaborator INDUSTRY

  • Ambrx, Inc.

    lead INDUSTRY

Principal Investigators

  • Mihaly Juhasz, MD · Accelsiors CRO & Consultancy Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • Hungary

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00778518 on ClinicalTrials.gov