Trial intelligence / Profile preview

Growth Hormone in Cystic Fibrosis

NCT00256555Phase 3

Key facts

Status: Withdrawn
Start: Feb 2000
Primary completion: Dec 2018
Sponsor: UT Southwestern Medical Center
Modality: Hormone, rProtein (Recombinant Protein), Biologic

Drugs: somatropin
Conditions: cystic fibrosis (CF)

Overview

Phase 3, randomised, open-label trial of somatropin in cystic fibrosis (CF) (2 arms), sponsored by UT Southwestern Medical Center. Primary endpoints: Height at 24 months, Height Velocity at 24 months and 2 more. Planned start Feb 2000; status: withdrawn.

Design

2 arms

Study design: RandomizedOpen-label

Immediate GH
GH treatment months 0-12, then observation.
Delayed GH
Observation months 0-12, then GH treatment months 12-24.

Who it enrols

Prepubertal children (ages 5-12) with cystic fibrosis and height or weight less than the 25th percentile, capable of performing pulmonary function tests. Patients with diabetes, insulin requirement, or Burkholderia cepacia colonization are excluded.

Endpoints

Primary

Height24 months
Height Velocity24 months
Body Weight24 months
Lean Body Mass24 months

Secondary

Forced Expiratory Volume in 1 Second24 months
Forced Vital Capacity24 months
Respiratory Muscle Strength (PImax and PEmax)24 months
Cystic Fibrosis Questionnaire24 months

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