Pegylated Interferon Alone or in Combination With Ezetimibe for Patients With Chronic Hepatitis D

Phase 2

• Conditions: Hepatitis D, Chronic
• Interventions: Drug: Pegylated interferon alfa; Drug: Ezetimibe

• Registration Number: NCT03105310
• Lead Sponsor: Aga Khan University

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.

The aim of the study io evaluate the utility of Ezetimibe in combination with pegylated interferon in patients with chronic HDV infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-12
• Status Verified: 2017-03
• Study First Submitted: 2017-03-26
• Study First Submitted QC: 2017-04-03
• Last Update Submitted: 2017-04-03
• Study First Posted: 2017-04-07
• Last Update Posted: 2017-04-07
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pegylated interferon with ezetimibe	Pegylated interferon alfa	Pegylated interferon alfa 180 micro-gram subcutaneous weekly for 24 weeks and Ezetimibe 10 mg orally for 24 weeks
Pegylated interferon	Pegylated interferon alfa	Pegylated interferon alfa alone 180 microgram subcutaneous weekly for 24 weeks
Pegylated interferon with ezetimibe	Ezetimibe	Pegylated interferon alfa 180 micro-gram subcutaneous weekly for 24 weeks and Ezetimibe 10 mg orally for 24 weeks

Primary Outcome Measures

Name	Time	Method
Change in HDV RNA quantitative measurements of >2 logs from baseline	24 weeks of therapy