Ezetimibe for Patients With Chronic Hepatitis D

Phase 2

• Conditions: Chronic Hepatitis D
• Interventions: Drug: Ezetimibe

• Registration Number: NCT03099278
• Lead Sponsor: Ziauddin Hospital

Brief Summary

Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and HDV hepatocyte entry that include two hydrophobes and one hydrogen bond acceptor. Therapy with Ezetimibe may lead to decline in hepatitis D virus levels. The aim of the study is to evaluate the utility of Ezetimibe in patients with chronic HDV infection

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Status Verified: 2017-03
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-03-28
• Last Update Submitted: 2017-03-28
• Study First Posted: 2017-04-04
• Last Update Posted: 2017-04-04
• Primary Completion: 2017-06
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Treatment experienced patients; non-responders of relapsers of pegylated interferon therapy
• Age 18 years or above
• Presence of anti-HDV in serum
• Presence of quantifiable HDV RNA in serum
• Elevated ALT > ULN

Exclusion Criteria

• Decompensated liver disease
• Patients with ALT levels greater than 10 times ULN (400 U/L)
• Pregnancy or inability to practice adequate contraception.
• Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR<50 ml/min), organ transplantation, serious psychiatric disease or depression and active coronary artery disease.
• Systemic immunosuppressive therapy
• Evidence of another form of liver disease in addition to viral hepatitis
• Active substance abuse, such as alcohol or injection drugs
• Hepatocellular carcinoma
• Concurrent hepatitis C infection or HIV coinfection
• Diagnosis of malignancy in the five years
• Concurrent usage of statins
• Concurrent use of any other drug known to inhibit NTCP
• Inability to understand or sign informed consent
• Any other condition, which in the opinion of the investigators would impede the patient's participation or compliance in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ezetimibe	Ezetimibe	-

Primary Outcome Measures

Name	Time	Method
• Decline of HDV RNA quantitative measurements of >1 logs from baseline	12 weeks of therapy

Trial Locations

Locations (1)

Ziauddin University Hospital; 🇵🇰 Karachi, Sindh, Pakistan