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

Sponsor

Aga Khan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03105310

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis D, Chronic	Drug: Pegylated interferon alfa Drug: Ezetimibe	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pegylated interferon Pegylated interferon alfa alone 180 microgram subcutaneous weekly for 24 weeks	Drug: Pegylated interferon alfa Pegylated interferon alfa
Experimental: Pegylated interferon with ezetimibe Pegylated interferon alfa 180 micro-gram subcutaneous weekly for 24 weeks and Ezetimibe 10 mg orally for 24 weeks	Drug: Pegylated interferon alfa Pegylated interferon alfa Drug: Ezetimibe Ezetimibe

Arm

Intervention/Treatment

Active Comparator: Pegylated interferon

Pegylated interferon alfa alone 180 microgram subcutaneous weekly for 24 weeks

Drug: Pegylated interferon alfa

Pegylated interferon alfa

Experimental: Pegylated interferon with ezetimibe

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

Drug: Pegylated interferon alfa

Pegylated interferon alfa

Drug: Ezetimibe

Ezetimibe

Outcome Measures

Primary Outcome Measures

Change in HDV RNA quantitative measurements of >2 logs from baseline [24 weeks of therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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