Clinical trial

A Study of Long-Term Human Recombinant Insulin-Like Growth Factor-1 (rhIGF-1) in Children With Short Stature Due to Growth Hormone Insensitivity Syndrome (GHIS)

Name

Study 1419

Description

The objective of this study was to evaluate the long-term safety and effectiveness of mecasermin (the study drug) in children with growth failure due to severe Primary insulin-like growth factor-1 deficiency (Primary IGFD).

Trial arms

Trial start

1991-05-20

Estimated PCD

2011-12-15

Trial end

2011-12-15

Status

Completed

Phase

Early phase I

Treatment

mecasermin

injections BID of rhIGF-1, mecasermin

Arms:

mecasermin, injections BID of rhIGF-1

Other names:

Increlex

Size

Primary endpoint

Annualized Height Velocity Up to 12 Years

Baseline (Pre-dose) and up to 12 years

Number of Naive Participants With Height Velocity <5 cm/y at the End of 1 Year of Study Treatment

Baseline (Pre-dose) and 1 year

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 92, 'type': 'ACTUAL'}}

Updated at

2023-07-06

1 organization

1 product

1 indication

Organization

Ipsen

Product

mecasermin

Indication

Growth Hormone Insensitivity Syndrome