Ezetimibe for Patients With Chronic Hepatitis D

NCT ID: NCT03099278

Last Updated: 2017-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-10-31

Brief Summary

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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

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Conditions

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Chronic Hepatitis D

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ezetimibe

Group Type EXPERIMENTAL

Ezetimibe

Intervention Type DRUG

Ezetimibe 20 mg oral daily

Interventions

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Ezetimibe

Ezetimibe 20 mg oral daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ziauddin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zaigham Abbas

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ziauddin University Hospital

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Zaigham Abbas

Role: CONTACT

922135862937

Facility Contacts

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Zaigham Abbas

Role: primary

Other Identifiers

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00281116ZAGE

Identifier Type: -

Identifier Source: org_study_id

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