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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

Tracking Information
First Submitted Date  ICMJE March 28, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date April 4, 2017
Actual Study Start Date  ICMJE January 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
• Decline of HDV RNA quantitative measurements of >1 logs from baseline [ Time Frame: 12 weeks of therapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ezetimibe for Patients With Chronic Hepatitis D
Official Title  ICMJE Ezetimibe for Patients With Chronic Hepatitis D
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis D
Intervention  ICMJE Drug: Ezetimibe
Ezetimibe 20 mg oral daily
Study Arms  ICMJE Experimental: Ezetimibe
Intervention: Drug: Ezetimibe
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 28, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03099278
Other Study ID Numbers  ICMJE 00281116ZAGE
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zaigham Abbas, Ziauddin Hospital
Study Sponsor  ICMJE Ziauddin Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ziauddin Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP