ID
20662
Description
Documentation Part: Liver Events Assessment An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline
Lien
https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1
Mots-clés
Versions (1)
- 09/03/2017 09/03/2017 -
Téléchargé le
9 mars 2017
DOI
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Licence
Creative Commons BY-NC 3.0
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Liver Events Assessment Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Liver Events Assessment Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Description
Liver Events Assessment
Alias
- UMLS CUI-1
- C1556667
Description
If Yes, stop investigational product, complete date stopped on Investigational Product form, contact GSK within 24 hours of occurrence, complete Liver Events Form and obtain the following tests: • PK blood sample within 24 hours of last dose (or 3x the investigational product half-life or t1/2). • Hepatitis A: Hepatitis A lgM antibody. • Hepatitis B: Hepatitis B surface antigen and Hepatitis B Core Antibody (lgM). • Hepatitis C: Hepatitis C RNA. • Hepatitis E IgM antibody (if subject resides or has travelled in past 3 months outside the USA or Canada). • Cytomegalovirus IgM antibody (CMV) • EBV (Epstein Barr viral capsid antigen IgM antibody) or if unavailable, obtain heterophile antibody or monospot testing. • CPK (serum creatine phosphokinase) • LDH (lactate dehydrogenase) • Bilirubin fractionation, if bilirubin >1.5xULN The following are only needed when ALT >3xULN and bilirubin >1.5xULN (>35% direct) • Anti-nuclear antibody • Anti-smooth muscle antibody • Type 1 anti-liver kidney microsomal antibodies (if available) • Liver Imaging (ultrasound, magnetic resonance, or computerised tomography)
Type de données
text
Alias
- UMLS CUI [1,1]
- C0023901
- UMLS CUI [1,2]
- C1556667
Similar models
Liver Events Assessment Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
C1556667 (UMLS CUI [1,2])