CTRI/2014/05/004615
Completed
Phase 4
A Prospective, Multi-centre, Observational Study to Profile Chronic Cholestatic Liver Diseases in Patient Population Receiving Udiliv in India - The Splendid Study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Chronic Cholestasis Liver Disease
- Sponsor
- Abbott India Limited
- Enrollment
- 250
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A patient can be included in the study if he/she meets all of the following inclusion criteria:
- •1\. Adult male or non\-pregnant female patient aged 18 to 65 years.
- •2\. Presence of chronic CLD as diagnosed by the physician.
- •3\. A patient in whom the decision to prescribe Udiliv (according to the local label) has been taken by the treating physician during the normal course of therapy.
- •4\. Patient who has given written authorization to provide data for the study.
Exclusion Criteria
- •Patients presenting with any of the following criteria will not be eligible for the study:
- •1\. Contraindications to Udiliv treatment (including hypersensitivity) according to the local label.
- •2\. Hepatocellular or metastatic liver carcinoma.
- •3\. Severe liver disease including but not limited to ascites, hepatic encephalopathy, hypoalbuminemia, coagulopathy.
- •4\. Child Pugh C Classification as diagnosed by the physician
- •5\. Pregnancy or lactation.
- •6\. Concomitant use of hepatotoxic drugs
- •7\. Previous enrollment in the present study.
- •8\. Other conditions that make the patientâ??s participation impossible (by investigator judgment).
Outcomes
Primary Outcomes
Not specified
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