Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).

Conditions

• IGF1 Deficiency

Eligibility Criteria

Sex

ALL

Age

2 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Increlex® — DRUG
  Increlex® (mecasermin \[rDNA origin\] injection), 10 mg/ml solution for injection, 40-120mcg/kg BID or 0,04 to 0,12 mg/kg BID, as prescribed by physician

Study Details

The Increlex® Global Registry is a descriptive, multicenter, observational, prospective, open-ended, non interventional, post-authorisation surveillance registry. The main purpose of this global registry is to collect, analyse and report safety data during and up to at least 5 years after the end of treatment in children and adolescents receiving Increlex® therapy for SPIGFD according to the locally approved product information.

Key Dates

Start date

Dec 9, 2008

Status verified

Feb 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

500 participants (estimated)

Primary Outcome Measure

Incidence of SAEs (including AESI of neoplasia) and all AEs, targeted AEs, deaths and withdrawals due to AEs. [ Time Frame: During the treatment period up to 30 days after the last dose. ]

Central Contacts

• Esteve Global Clinical Development
  [email protected]

Locations (7)

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