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

A Prospective, Multi-centre, Observational Study to Profile Chronic Cholestatic Liver Diseases in Patient Population Receiving Udiliv in India - The Splendid Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2014/05/004615
Enrollment
250
Registered
2014-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Cholestasis Liver Disease

Interventions

Intervention1: Udiliv: Route - Oral. Dosage - As per investigator discretion.Observation period of the study will be 8 weeks while the patient is on Udiliv treatment as permitted according by local la

Sponsors

Abbott India Limited
Lead Sponsor

Eligibility

Inclusion 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

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).

Design outcomes

Primary

MeasureTime frame
(1) To determine the profile of chronic CLD patients treated with Udiliv in the routine clinical care setting. (2) To gain insight into the decision making process of physicians prescribing Udiliv.Timepoint: 12 weeks

Secondary

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

Countries

India

Contacts

Public ContactVishal Vaidya

Jehangir Hospital

parimallawate@hotmail.com91-20-267268800

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026