Ezetimibe for Patients With Chronic Hepatitis D

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03099278

Enrollment

Registered

2017-04-04

Start date

2017-01-31

Completion date

2017-10-31

Last updated

2017-04-04

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

Conditions

Chronic Hepatitis D

Keywords

hepatitis D, Ezetimibe, HDV RNA

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

Interventions

DRUGEzetimibe

Ezetimibe 20 mg oral daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Pakistan

Contacts

Primary ContactZaigham Abbas

drzabbas@gmail.com922135862937

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026