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

Aga Khan University

Status and phase: Unknown; Phase 2

Conditions: Hepatitis D, Chronic

Treatments: Drug: Pegylated interferon alfa; Drug: Ezetimibe

Study type: Interventional

Funder types: Other

Identifiers

NCT03105310

3636-Med-ERC

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Pegylated interferon

Active Comparator group

Description:

Pegylated interferon alfa alone 180 microgram subcutaneous weekly for 24 weeks

Treatment:

Drug: Pegylated interferon alfa

Pegylated interferon with ezetimibe

Experimental group

Description:

Pegylated interferon alfa 180 micro-gram subcutaneous weekly for 24 weeks and Ezetimibe 10 mg orally for 24 weeks

Treatment:

Drug: Ezetimibe

Drug: Pegylated interferon alfa