This is an observational study in patients to Profile Chronic Cholestatic Liver Diseases who are prescribed Udiliv for their treatment

Phase 4

Completed

• Conditions: Health Condition 1: null- Chronic Cholestasis Liver Disease

• Registration Number: CTRI/2014/05/004615
• Lead Sponsor: Abbott India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

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).

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(1) To determine the profile of chronic CLD patients treated with Udiliv in the routine clinical care setting. <br/ ><br>(2) To gain insight into the decision making process of physicians prescribing Udiliv.Timepoint: 12 weeks

Secondary Outcome Measures

Name	Time	Method
To better understand the effectiveness, tolerability, and compliance of Udiliv therapy in the patient population with chronic CLD.Timepoint: 12 weeks