Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency

NCT00125190 | Completed Phase 2 Results DMC

• 2 other identifiers: MS3082019-001095-11
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to assess the effects of once daily dosing of recombinant human insulin-like growth factor (rhIGF-1) in increasing height velocity.

Conditions

Insulin-Like Growth Factor-1 Deficiency; Growth Disorders

Keywords

Primary IGF-1 Deficiency; IGF-1

Outcome Measures

Primary Outcomes (2)

• Height Velocity From Pretreatment (Week 0) to Week 34

  Height was measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. The subject was repositioned between each measurement. Height velocity during an interval of time is defined as the change in height during the time interval divided by the duration of the time interval. Missing Week 34 heights were imputed using the last height SD score carried forward.

  Pretreatment to Week 34

• Height Velocity From Week 34 to 86

  Height was measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. The subject was repositioned between each measurement. Height velocity during an interval of time is defined as the change in height during the time interval divided by the duration of the time interval. Missing Week 86 heights were imputed using the last height SD score carried forward.

  Week 34 to 86

Secondary Outcomes (5)

• Change in Height SD Score From Pretreatment to Week 34

  Pretreatment and Week 34

• Change in Height SD Score From Pretreatment to Week 86

  Pretreatment and Week 86

• Change in Bone Age From Pretreatment to Week 86 Minus Change in Chronological Age

  Pretreatment to Week 86

• Percent Change in Serum Concentration of IGFBP-1, IGFBP-2 and IGFBP-3 From Pretreatment to Week 86

  Pretreatment and Week 86

• Percent Change in Serum Concentration of ALS From Pretreatment to Week 86

  Pretreatment and Week 86

Study Arms (1)

rhIGF-1 QD

EXPERIMENTAL

Subjects received subcutaneous injection (SC) injections of rhIGF-1 once a day.

Drug: rhIGF-1 (mecasermin) for a period of 86 weeks

Interventions

rhIGF-1 (mecasermin) for a period of 86 weeks DRUG

Once a day rhIGF-1 injections

rhIGF-1 QD

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronological age ≥ 3
• Chronological age or bone age ≤ 12 for boys and ≤ 11 for girls
• Prepubertal at Visit 1
• Height SD score of \< -2
• IGF-1 SD score of \< -2

You may not qualify if:

• Prior treatment with GH, IGF-1, or other growth-influencing medications
• Growth failure associated with other identifiable causes (e.g., syndromes, chromosomal abnormality)
• Chronic illness such as diabetes, cystic fibrosis, etc.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Ipsen

Brisbane, California, 94005, United States

Location

MeSH Terms

Conditions

Growth Disorders

Interventions

mecasermin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Director
• Organization: Ipsen

clinical.trials@ipsen.com

see email

Study Officials

• Ipsen Study Director, M.D.

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2005
• First Posted: July 29, 2005
• Study Start: July 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: July 27, 2020
• Results First Posted: April 15, 2010

Record last verified: 2020-07

Locations

US (1)