Hepatitis D, Chronic
Conditions
Keywords
Hepatitis D, Ezetimibe, Pegylated interferon
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.
Interventions
Pegylated interferon alfa
DRUGEzetimibe
Ezetimibe
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HDV RNA quantitative measurements of >2 logs from baseline | 24 weeks of therapy |
Outcome results
None listed