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

Short Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169637
• Other study ID #: 2002.301
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: October 30, 2008
• Start date: June 2006
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

Age 3-18 year with a bone age test under 18-year Children with short bowel syndrome and intestinal insufficiency, the remaining bowel length should be under 80 cm after the first post-surgical period.

Parenteral nutrition dependency: under parenteral nutrition for at least 3 years with parenteral glycolipidic diet > or = 30% of the total caloric need for age. The parenteral diet should have been stable for at least 3 months.

Parents consent

Exclusion Criteria:

Over 20% change in caloric daily requirement within the last 6 months before inclusion.

Surgery on digestive tube within the last 3 months. Administration of drugs targeting digestion (decontamination, macrobiotic, gastric dressing, chelating agents of biliary salts) within the last month.

History or presence of tumoral process, leukaemia, minor intracranial hypertension, epiphysiolysis, carpal tunnel syndrome.

Ongoing infection (fever and inflammatory biologic syndrome), progressive inflammatory syndrome.

Heart failure, renal and respiratory insufficiency. Allergy to solvent. Any condition making impossible the follow-up of the patient during the study. Person participating in another clinical trial or taking another medication under investigation within one month before inclusion.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

Drug:
• rhGH

Locations

Country	Name	City	State
France	Alain LACHAUX	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the efficacy of rhGH compared to "no treatment" on partial or total weaning off of parenteral nutrition in children with short bowel syndrome after 4 months
Secondary	Evaluate the persistent efficacy (remaining rate of weaning off) 6 months after rhGH discontinuation.
Secondary	To evaluate the intestinal absorption (input-output within 3 days) at the end of the randomized study (month 4) and at the end of study (month 14)
Secondary	To quantify the variation in body composition (auxology and biphotonic absorptiometry) at the end of the randomized study (month 4) and at the end of study (month 14)
Secondary	To evaluate the tolerance and safety of rhGH at the end of the randomized study (month 4) and at the end of study (month 14.