Ezetimibe for Patients With Chronic Hepatitis D

Chronic Hepatitis D Clinical Trial

Official title:

Ezetimibe for Patients With Chronic Hepatitis D

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03099278
• Other study ID #: 00281116ZAGE
• Status: Recruiting
• Phase: Phase 2
• First received: March 28, 2017
• Last updated: March 28, 2017
• Start date: January 2017
• Est. completion date: October 2017

Study information

• Verified date: March 2017
• Source: Ziauddin Hospital
• Contact: Zaigham Abbas
• Phone: 922135862937
• Email: drzabbas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis D
• Hepatitis
• Hepatitis A
• Hepatitis D
• Hepatitis D, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Ezetimibe
Ezetimibe 20 mg oral daily

Locations

Country	Name	City	State
Pakistan	Ziauddin University Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Ziauddin Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Decline of HDV RNA quantitative measurements of >1 logs from baseline		12 weeks of therapy