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| Sponsored by: |
King's College Hospital NHS Trust |
|---|---|
| Information provided by: | King's College Hospital NHS Trust |
| ClinicalTrials.gov Identifier: | NCT00539565 |
Purpose
Biliary atresia is a congenital disorder of bile duct development or destruction of established but immature bile ducts. The study tests the hypothesis that post-operative steroids improve outcome following the Kasai procedure - the commonest surgical treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Biliary Atresia |
Drug: prednisolone Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary Atresia |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2000 |
| Estimated Study Completion Date: | September 2008 |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
oral corticosteroids
|
Drug: prednisolone
2 mg/kg /day from post-op day 7 - day 21 1 mg/kg /day from post-op day 22 - day 30 |
|
B: Placebo Comparator
as for active regimen
|
Drug: placebo |
Biliary atresia is a potentially fatal condition of infants presenting as persisting jaundice in the first few weeks of life. The disease is characterised by obstruction and damage to the intra and extrahepatic parts of the biliary tree. Within the liver there is also a pronounced inflammatory response. The initial treatment is an attempt, by surgery, to restore bile flow by excising the obliterated extrahepatic bile ducts and joining part of the intestine to the bile "root" of the liver (the porta hepatis). This is known as the Kasai procedure. This is successful in ~50% of cases in reducing the level of jaundice to near-normal values. The use of steroids post-operatively has been suggested as improving outcome by diminishing the inflammatory response.
Eligibility| Ages Eligible for Study: | up to 100 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | KCH99LG21 |
| Study First Received: | October 3, 2007 |
| Last Updated: | October 3, 2007 |
| ClinicalTrials.gov Identifier: | NCT00539565 |
| Health Authority: | United Kingdom: Research Ethics Committee |
|
biliary atresia Kasai portoenterostomy corticosteroids |
|
Digestive System Abnormalities Digestive System Diseases Methylprednisolone Bile Duct Diseases Biliary Tract Diseases Prednisolone |
Methylprednisolone acetate Biliary atresia Prednisolone acetate Congenital Abnormalities Biliary Atresia Methylprednisolone Hemisuccinate |
|
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids Pharmacologic Actions |
