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

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Primary completion date: Jun 2008
    • Secondary endpoints: 4 to 11
    • Study arms: 0 to 2
    v9
  2. Enrollment target: estimated 20 to confirmed 14v8
  3. Trial status: Recruiting to Completed
    • Study completion date: Jun 2008
    • Site details revised
    • Eligibility criteria shortened, about 3 words
    v7
  4. 2 versions Re-verified since Apr 26, 2007, no change to tracked fieldsv5-v6
  5. Start date: Nov 2005 to Jun 2006v4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Eligibility criteria revised
    • Site details revised
    v3
  2. Start date: Sep 2005 to Nov 2005v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00169637
Lead Sponsor Hospices Civils de Lyon
Conditions
(from sponsor)		 Short Bowel Syndrome
Related terms Short Bowel Syndrome
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov