search
Back to results

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

Primary Purpose

Hepatitis D, Chronic

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pegylated interferon alfa
Ezetimibe
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis D, Chronic focused on measuring Hepatitis D, Ezetimibe, Pegylated interferon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Pegylated interferon

    Pegylated interferon with ezetimibe

    Arm Description

    Pegylated interferon alfa alone 180 microgram subcutaneous weekly for 24 weeks

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 26, 2017
    Last Updated
    April 3, 2017
    Sponsor
    Aga Khan University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03105310
    Brief Title
    Pegylated Interferon Alone or in Combination With Ezetimibe for Patients With Chronic Hepatitis D
    Official Title
    Pegylated Interferon Alone or in Combination With Ezetimibe for Patients With Chronic Hepatitis D
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    June 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aga Khan University

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis D, Chronic
    Keywords
    Hepatitis D, Ezetimibe, Pegylated interferon

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pegylated interferon
    Arm Type
    Active Comparator
    Arm Description
    Pegylated interferon alfa alone 180 microgram subcutaneous weekly for 24 weeks
    Arm Title
    Pegylated interferon with ezetimibe
    Arm Type
    Experimental
    Arm Description
    Pegylated interferon alfa 180 micro-gram subcutaneous weekly for 24 weeks and Ezetimibe 10 mg orally for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Pegylated interferon alfa
    Intervention Description
    Pegylated interferon alfa
    Intervention Type
    Drug
    Intervention Name(s)
    Ezetimibe
    Intervention Description
    Ezetimibe
    Primary Outcome Measure Information:
    Title
    Change in HDV RNA quantitative measurements of >2 logs from baseline
    Time Frame
    24 weeks of therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs