NCT00169637已完成3 期
Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
GH group (4 months of Growth Hormone)
Experimental
干预措施: rhGH (Drug)
a control (CTR) group (4 months without Growth Hormone, followed by 4 months with GH)
Experimental
4 months without GH, followed by 4 months with GH
干预措施: rhGH (Drug)
结局指标
主要结局
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
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
时间窗: 4 months
次要结局
- 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.
- number of adverse events glucose intolerance(14 months)
- To evaluate the intestinal absorption (input-output within 3 days) at the end of study (month 14)(14 months)
- Evaluate the persistent efficacy (remaining rate of weaning off) 6 months after rhGH discontinuation.(6 months)
- To evaluate the intestinal absorption (input-output within 3 days) at the end of the randomized study (month 4)(4 months)
- To quantify the variation in body composition (auxology) at the end of the randomized study (month 4)(4 months)
- To quantify the variation in body composition (biphotonic absorptiometry) at the end of the randomized study (month 4)(4 months)
- To quantify the variation in body composition (auxology) at the end of study (month 14)(14 months)
- To quantify the variation in body composition ( biphotonic absorptiometry) at the end of study (month 14)(14 months)
- number of adverse events(4 months)
- number of adverse events glucose intolerance(4 months)
- number of adverse event(14 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) InfectionHepatitis B, ChronicNCT04749368Brii Biosciences Limited91
已完成
3 期
A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic HypogonadismHypogonadismNCT01084265Merck KGaA, Darmstadt, Germany31
终止
3 期
An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.Acute Pain From Ankle Sprain or StrainNCT02089425Kowa Research Institute, Inc.384
已完成
3 期
Efficacy, and Safety Study of Optimized Background Antiretroviral Regimen (OB) in Combination With Enfuvirtide in the Treatment-Experienced Participants With Human Immunodeficiency Virus-1 (HIV-1) InfectionHIV InfectionsNCT02733419Hoffmann-La Roche84
招募中
3 期
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 MutationMetastatic Breast CancerNCT05696626LeonaBio600