Pegylated Interferon Alone or in Combination With Ezetimibe for Patients With Chronic Hepatitis D
NCT ID: NCT03105310
Last Updated: 2017-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2016-01-31
2017-06-30
Brief Summary
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The aim of the study io evaluate the utility of Ezetimibe in combination with pegylated interferon in patients with chronic HDV infection.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pegylated interferon
Pegylated interferon alfa alone 180 microgram subcutaneous weekly for 24 weeks
Pegylated interferon alfa
Pegylated interferon alfa
Pegylated interferon with ezetimibe
Pegylated interferon alfa 180 micro-gram subcutaneous weekly for 24 weeks and Ezetimibe 10 mg orally for 24 weeks
Pegylated interferon alfa
Pegylated interferon alfa
Ezetimibe
Ezetimibe
Interventions
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Pegylated interferon alfa
Pegylated interferon alfa
Ezetimibe
Ezetimibe
Eligibility Criteria
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Inclusion Criteria
* Presence of quantifiable HDV RNA in serum
* Elevated ALT \> ULN
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Aga Khan University
OTHER
Responsible Party
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Zaigham Abbas
Consultant Gastroenterologist
Other Identifiers
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3636-Med-ERC
Identifier Type: -
Identifier Source: org_study_id
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