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Ezetimibe for Patients With Chronic Hepatitis D

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03099278
Recruitment Status : Unknown
Verified March 2017 by Zaigham Abbas, Ziauddin Hospital.
Recruitment status was:  Recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Zaigham Abbas, Ziauddin Hospital

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. Therapy with Ezetimibe may lead to decline in hepatitis D virus levels. The aim of the study is to evaluate the utility of Ezetimibe in patients with chronic HDV infection

Condition or disease Intervention/treatment Phase
Chronic Hepatitis D Drug: Ezetimibe Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ezetimibe for Patients With Chronic Hepatitis D
Actual Study Start Date : January 2017
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe

Arm Intervention/treatment
Experimental: Ezetimibe Drug: Ezetimibe
Ezetimibe 20 mg oral daily




Primary Outcome Measures :
  1. • Decline of HDV RNA quantitative measurements of >1 logs from baseline [ Time Frame: 12 weeks of therapy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment experienced patients; non-responders of relapsers of pegylated interferon therapy
  • Age 18 years or above
  • 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
  • Any other condition, which in the opinion of the investigators would impede the patient's participation or compliance in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099278


Contacts
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Contact: Zaigham Abbas 922135862937 drzabbas@gmail.com

Locations
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Pakistan
Ziauddin University Hospital Recruiting
Karachi, Sindh, Pakistan, 75600
Contact: Zaigham Abbas         
Sponsors and Collaborators
Ziauddin Hospital

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Responsible Party: Zaigham Abbas, Professor, Ziauddin Hospital
ClinicalTrials.gov Identifier: NCT03099278     History of Changes
Other Study ID Numbers: 00281116ZAGE
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Zaigham Abbas, Ziauddin Hospital:
hepatitis D
Ezetimibe
HDV RNA

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis D
Hepatitis D, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents