Ezetimibe for Patients With Chronic Hepatitis D

NCT03099278 | Unknown Phase 2 FDA Drug

• 1 other identifier: 00281116ZAGE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Hepatitis D

Keywords

hepatitis D; Ezetimibe; HDV RNA

Outcome Measures

Primary Outcomes (1)

• • Decline of HDV RNA quantitative measurements of >1 logs from baseline

  12 weeks of therapy

Study Arms (1)

Ezetimibe

EXPERIMENTAL

Drug: Ezetimibe

Interventions

Ezetimibe DRUG

Ezetimibe 20 mg oral daily

Ezetimibe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziauddin Hospital: lead

Study Sites (1)

Ziauddin University Hospital

Karachi, Sindh, 75600, Pakistan

RECRUITING

MeSH Terms

Conditions

Hepatitis D, Chronic; Hepatitis D

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Zaigham Abbas

CONTACT

922135862937; drzabbas@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 4, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)