Long-Term Treatment With rhIGF-1 in GHIS
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ClinicalTrials.gov Identifier: NCT00571727 |
Recruitment Status :
Completed
First Posted : December 12, 2007
Last Update Posted : January 7, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Growth Hormone Insensitivity Syndrome | Drug: mecasermin | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 92 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Study of the Long-Term Human Recombinant Insulin-Like Growth Factor-1 (rhIGF-1) Treatment in Children With Short Stature Due to Growth Hormone Insensitivity Syndrome (GHIS) |
Study Start Date : | January 1990 |
Actual Primary Completion Date : | October 2004 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: mecasermin, injections BID of rhIGF-1 |
Drug: mecasermin
injections BID of rhIGF-1, mecasermin
Other Name: Increlex |
- Change in height [ Time Frame: duration of study ]
- safety [ Time Frame: duration of study ]

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Ages Eligible for Study: | 2 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Height <-2SD for age and gender
- IGF-1 <-2SD for age and gender
- Evidence of GH resistance
Exclusion Criteria:
- closed epiphyses
- prior active malignancy
- major organ disfunction
- treatment with medications that would diminish growth
- clinically significant cardiac abnormalities

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571727
United States, California | |
Ipsen | |
Brisbane, California, United States, 94005 |
Study Director: | Ipsen Medical Director | Ipsen |
Responsible Party: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00571727 |
Other Study ID Numbers: |
Study 1419 |
First Posted: | December 12, 2007 Key Record Dates |
Last Update Posted: | January 7, 2019 |
Last Verified: | January 2019 |
growth insulin like growth factor Larons syndrome |
Laron Syndrome Syndrome Disease Pathologic Processes Dwarfism Bone Diseases, Developmental Bone Diseases |
Musculoskeletal Diseases Genetic Diseases, Inborn Endocrine System Diseases Mecasermin Growth Substances Physiological Effects of Drugs |