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

April 3, 2017 updated by: Zaigham Abbas, Aga Khan University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HDV RNA quantitative measurements of >2 logs from baseline
Time Frame: 24 weeks of therapy
24 weeks of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

March 26, 2017

First Submitted That Met QC Criteria

April 3, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3636-Med-ERC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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