Ezetimibe for Patients With Chronic Hepatitis D

Ziauddin Hospital

Status and phase

Unknown

Phase 2

Conditions

Chronic Hepatitis D

Treatments

Drug: Ezetimibe

Study type

Interventional

Funder types

Other

Identifiers

NCT03099278

00281116ZAGE

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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