Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome

Summary

This is a randomized controlled, parallel group, open label versus "no treatment" trial which evaluate the efficacy of rhGH on weaning off parenteral nutrition in children with short bowel syndrome.The total follow-up is 14 months; 4 months for each group after randomization; At the end of the first four months: the treated group will be followed within 6 months, the untreated group will receive compassionately rhGH for 4 months and followed-up for 6 months after the end of the treatment period.

Timeline

Start

2006-06

Primary completion

2008-06

Completion

2008-06

Publications

• Results Peretti N, Loras-Duclaux I, Kassai B, Restier-Miron L, Guimber D, Gottrand F, Coopman S, Michaud L, Marinier E, Yantren H, Michalski MC, Aubert F, Mercier C, Pelosse M, Lopez M, Chatelain P, Lachaux A. Growth hormone to improve short bowel syndrome intestinal autonomy: a pediatric randomized open-label clinical trial. JPEN J Parenter Enteral Nutr. 2011 Nov;35(6):723-31. doi: 10.1177/0148607111415531. Epub 2011 Oct 5.

Drugs

Indications