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Main
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Note: This record shows only the 20 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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10 June 2013 |
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Main ID: |
NCT00940485 |
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Date of registration:
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16/06/2009 |
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Primary sponsor: |
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Public title:
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A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B
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Scientific title:
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A Study on Optimizing HBeAg Seroconversion in HBeAg Positive CHB Patients With Combination or Sequential Treatment of Pegylated Interferon Alpha-2a and Entecavir |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00940485 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients, >=18 and
- HBeAg positive chronic hepatitis B
- Pre-treatment with entecavir for 9-36 months
Exclusion Criteria:
- Antiviral, antineoplastic or immunomodulatory treatment
- Co-infection with active hepatitis A, C or D, or HIV
- Evidence of decompensated liver disease
- History or other evidence of a medical condition associated with chronic liver
disease other than viral hepatitis
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatitis B, Chronic
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Intervention(s)
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Drug: entecavir
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Drug: peginterferon alfa-2a [Pegasys]
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Primary Outcome(s)
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HBeAg seroconversion
[Time Frame: Week 48]
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Secondary Outcome(s)
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Adverse events, laboratory parameters, vital signs
[Time Frame: Week 48]
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Loss of HBeAg; proportion of patients who achieve HBV DNA <1000 copies/mL;ALT normalization; quantitative HBeAg and HBsAg measurement;HBsAg loss/seroconversion
[Time Frame: Week 48]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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