Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome
Information source: Hospices Civils de Lyon
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Short Bowel Syndrome
Intervention: rhGH (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hospices Civils de Lyon Official(s) and/or principal investigator(s):
Alain LACHAUX, MD, Principal Investigator, Affiliation: Hospices Civils de Lyon
Overall contact:
alain LACHAUX, MD, Phone: 33 472 110 390, Email: alain.lachaux@chu-lyon.fr
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.
Clinical Details
Official title: Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome
Study design: Randomized, Open Label, Uncontrolled, Parallel Assignment
Primary outcome: 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 outcome: Evaluate the persistent efficacy (remaining rate of weaning off) 6 months after rhGH discontinuation.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) 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) 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.
Eligibility
Minimum age: 3 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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 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 non-affiliated to social security.
Person participating in another clinical trial or taking another medication under
investigation within one month before inclusion.
Locations and Contacts
alain LACHAUX, MD, Phone: 33 472 110 390, Email: alain.lachaux@chu-lyon.fr
Alain LACHAUX, Lyon 69437, France; Recruiting
Alain LACHAUX, MD, Phone: 33 472 110 390, Email: alain.lachaux@chu-lyon.fr
Additional Information
Starting date: June 2006
Last updated: October 3, 2007
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