Growth Hormone Insensitivity Syndrome (GHIS) Clinical Trial
| NCT number | NCT00368173 |
| Other study ID # | INSM-110-303 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2/Phase 3 |
| First received | August 23, 2006 |
| Last updated | September 11, 2012 |
| Verified date | September 2012 |
| Source | Insmed Incorporated |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 2 Years to 18 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Dr. Alicia Belgorosky | Buenos Aires | |
| Argentina | Dr. Christina Bazan | Tucuman | |
| Australia | Dr. Bruce King | Newcastle | |
| Brazil | Dr. Durval Damiani | Sao Paulo | |
| China | Dr. Kwok-leung NG | Hong Kong | |
| Egypt | Dr. Mohamed EL Kholy | Cairo | |
| Germany | Professor Annette Greuters | Berlin | |
| Israel | Tiosano Dov | Haifa | |
| Italy | Maria Carolina Salerno | Naples | |
| Norway | Dr. Hilde Bjorndalen | Oslo | |
| Peru | Dr. Carlos del Aguila | Lima | |
| Slovakia | Dr. Magdalena Paskova | Kosice | |
| Turkey | Professor Nursen Yordam | Ankara | |
| United Kingdom | Dr. Cecilia Camacho-Hubner | London | |
| United States | Robert Rapaport, MD | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Insmed Incorporated |
United States, Argentina, Australia, Brazil, China, Egypt, Germany, Israel, Italy, Norway, Peru, Slovakia, Turkey, United Kingdom,