Growth Hormone Treatment Study in Children With Cystic Fibrosis

• Status: Withdrawn
• Trial end date: 2018-12-12
• Target enrollment: 0
• Participant gender: All

Summary

Cystic fibrosis (CF) is a catabolic condition, and children affected with this disease frequently have problems with growth, despite adequate nutrition. We hypothesize that the anabolic effects of growth hormone (GH) will improve the height and weight of CF patients and thereby improve their clinical status and their quality of life. We further hypothesize that these effects will be sustained for at least one year after GH treatment is complete.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Genentech, Inc.
• Treatments: Hormones

Criteria

Inclusion Criteria:

• prepubertal CF patients (ages 5-12)

• capable of performing pulmonary function tests

• less than the 25th percentile for age and sex normal values for height and/or weight.

Exclusion Criteria:

• previous diagnosis with diabetes

• previous insulin requirement

• inability to perform pulmonary function testing

• colonization with burkholderia cepacia