A Study to Compare Efficacy and Safety of Tenofovir Used Alone or in Combination With Pegylated Interferon Alpha-2b in Participants With Chronic Hepatitis B and Elevated Alanine Aminotransferase (MK-4031-384)
NCT ID: NCT01727271
Last Updated: 2013-09-19
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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WITHDRAWN
PHASE4
INTERVENTIONAL
2013-08-31
2017-08-31
Brief Summary
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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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Tenofovir Monotherapy
Tenofovir 300 mg tablet, orally (PO) once daily for 8 weeks, then Tenofovir 300 mg tablet, PO, once daily for an additional 96 weeks (total treatment duration 104 weeks)
Tenofovir
PegIFN-2b/Tenofovir Sequential Therapy
Tenofovir 300 mg tablet, PO, once daily for 8 weeks, then PegIFN-2b, 1.5 mcg/kg subcutaneously (SC), once weekly, for 24 weeks, then Tenofovir 300 mg tablet, PO, once daily for 72 weeks (total treatment duration 104 weeks)
Tenofovir
Pegylated interferon alpha-2b
Peg-IFN-2b + Tenofovir Combination Therapy
Tenofovir 300 mg tablet, PO once daily for 8 weeks, then pegIFN-2b, 1.5 mcg/kg SC once weekly and tenofovir 300 mg tablet, PO, once daily for 24 weeks, and then tenofovir 300 mg tablet, PO, once daily for 72 weeks (total treatment duration 104 weeks)
Tenofovir
Pegylated interferon alpha-2b
Interventions
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Tenofovir
Pegylated interferon alpha-2b
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elevated serum ALT level
* Liver biopsy or a non-invasive investigation within 12 months prior to randomization with Chronic Hepatitis B
* Treatment naïve or history of interferon for not more than 1 month, taken at least 6 months before enrollment
* Compensated liver disease
Exclusion Criteria
* Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
* Need for prolonged or frequent use of systemic acyclovir or famciclovir
* Previously received lamivudine or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog and were resistant to these drugs
* History of variceal bleeding or other GI bleeding due to portal hypertension, hepatic encephalopathy, spontaneous bacterial peritonitis, Grade III and IV esophageal varices unless banded or other clinical signs of hepatic decompensation
* History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
* Need for potentially hepatotoxic drugs (e.g. dapsone, erythromycin, fluconazole, ketoconazole, rifampin, and anti-tuberculosis regimens) or nephrotoxic drugs (e.g. frequent nonsteroidal anti-inflammatories, aminoglycosides, amphotericin B, and foscarnet)
* One or more additional known primary or secondary causes of liver disease, other than hepatitis B
* History of clinical pancreatitis
* Pregnant or breastfeeding
* Female participants of childbearing potential and male participants must be willing to use acceptable method of birth control.
* Medical condition that requires frequent or prolonged use of systemic corticosteroids
* Use of warfarin or other anticoagulants during 30 days prior to screening or if expected to be needed during the study period
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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4031-384
Identifier Type: -
Identifier Source: org_study_id