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

Hepatitis D, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03105310
• Other study ID #: 3636-Med-ERC
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 26, 2017
• Last updated: April 3, 2017
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: March 2017
• Source: Aga Khan University
• Contact: n/a
• 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Pegylated interferon alfa
Pegylated interferon alfa
• Ezetimibe
Ezetimibe

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HDV RNA quantitative measurements of >2 logs from baseline		24 weeks of therapy