IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome

NCTNCT00368173Other idINSM-110-303

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2/3
Enrollment: Not stated
Sponsor: Insmed Incorporated · Industry
Design: Not randomized · Open label (no masking)
Countries: 14 countries
United States, Argentina, Australia, Brazil, China, Egypt, Germany, Israel, Italy, Norway, Peru, Slovakia, Turkey (Türkiye), United Kingdom
Start: Not stated
Primary completion: Not stated
Completion: Not stated
First posted: 24 Aug 2006 (estimated)
Last update posted: 13 Sept 2012 (estimated)
Conditions: Growth Hormone Insensitivity Syndrome (GHIS) · Laron Syndrome

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

STUDY OBJECTIVE To evaluate the safety, tolerability, and efficacy, as growth velocity (statural growth), of rhIGF-I/rhIGFBP-3 administered for 12 months in pre-pubertal children and adolescents with GHIS. STUDY DESIGN This study is an open-label, multi-center clinical trial to evaluate the safety and effectiveness of rhIGF-I/rhIGFBP-3 to increase rate of growth when administered once daily for 12 months in children and adolescents with growth hormone insensitivity syndrome (GHIS) such as Laron Syndrome. At the end of the initial twelve-month treatment period, additional safety and long-term efficacy data will be assessed in a second 12 month treatment period.

Interventions

rhIGF-I/rhIGFBP-3Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes0

Outcomes the sponsor listed as primary.

The registry lists no primary outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 2 Years up to 18 Years
Healthy volunteers: Not stated

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. A diagnosis of GHIS such as Laron syndrome, 2. 2 - 18 years of age, 3. Height less than or equal to -3SD for age, 4. Pre-pubertal, defined as Tanner breast stage 1 or testis volume \<4mL Exclusion Criteria: 1. Children in puberty, 2. Diagnosed malignancy, 3. A diagnosis of diabetes mellitus

PepBank is a research reference. Talk to a doctor before you use any peptide.