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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03099278 |
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Date of registration:
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28/03/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ezetimibe for Patients With Chronic Hepatitis D
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Scientific title:
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Ezetimibe for Patients With Chronic Hepatitis D |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03099278 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Zaigham Abbas |
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Address:
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Telephone:
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922135862937 |
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Email:
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drzabbas@gmail.com |
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Affiliation:
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Name:
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Zaigham Abbas |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis D
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Intervention(s)
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Drug: Ezetimibe
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Primary Outcome(s)
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• Decline of HDV RNA quantitative measurements of >1 logs from baseline
[Time Frame: 12 weeks of therapy]
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Secondary ID(s)
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00281116ZAGE
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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