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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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14 November 2016 |
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Main ID: |
NCT02570191 |
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Date of registration:
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05/10/2015 |
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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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A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)
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Scientific title:
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An Open-label, Multicenter, National, Not-randomized Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (PEGASYS) in Patients With HBeAg-negative Chronic Hepatitis B |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02570191 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Bulgaria
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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 participants 18-70 years of age
- Positive test result for HBsAg for >6 months
- Naive to treatment for HBV
- On liver biopsy, liver disease consistent with chronic HBV, with or without
compensated cirrhosis
Exclusion Criteria:
- Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)
- Decompensated liver disease
- Hepatocellular cancer
- Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal
to 6 months before study drug
- Medical condition associated with chronic liver disease
Age minimum:
18 Years
Age maximum:
70 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: Peginterferon alfa-2a
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Primary Outcome(s)
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Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up
[Time Frame: 72 Weeks]
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Alanine Transaminase (ALT) Normalization at the End of Follow-Up
[Time Frame: 72 Weeks]
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Secondary Outcome(s)
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Alanine Transaminase (ALT) Normalization at the End of Treatment
[Time Frame: 48 Weeks]
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HBV DNA Suppression <20000 Copies/mL at the End of Treatment
[Time Frame: 48 Weeks]
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Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up
[Time Frame: 72 Weeks]
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Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up
[Time Frame: 72 Weeks]
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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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