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

NCT03105310 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 3636-Med-ERC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis D, Chronic

Keywords

Hepatitis D; Ezetimibe; Pegylated interferon

Outcome Measures

Primary Outcomes (1)

• Change in HDV RNA quantitative measurements of >2 logs from baseline

  24 weeks of therapy

Study Arms (2)

Pegylated interferon

ACTIVE COMPARATOR

Pegylated interferon alfa alone 180 microgram subcutaneous weekly for 24 weeks

Drug: Pegylated interferon alfa

Pegylated interferon with ezetimibe

EXPERIMENTAL

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

Drug: Pegylated interferon alfa; Drug: Ezetimibe

Interventions

Pegylated interferon alfa DRUG

Pegylated interferon alfa

Pegylated interferon; Pegylated interferon with ezetimibe

Ezetimibe DRUG

Ezetimibe

Pegylated interferon with ezetimibe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of anti-HDV in serum
• Presence of quantifiable HDV RNA in serum
• Elevated ALT \> ULN

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

MeSH Terms

Conditions

Hepatitis D, Chronic; Hepatitis D

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologist

Study Record Dates

• First Submitted: March 26, 2017
• First Posted: April 7, 2017
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: April 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share