A Study to Evaluate the Efficacy and Safety of Clevudine and Peg-interferon in Sequence Compared With Clevudine Alone in the Patients With HBeAg(+) Chronic Hepatitis B or Clevudine and Peg-interferon Sequential Treatment in Patients With Chronic Hepatitis B Who Have HBeAg(+)
This study is currently recruiting participants.
Verified July 2012 by Bukwang Pharmaceutical
Sponsor:
Bukwang Pharmaceutical
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01264367
First received: December 19, 2010
Last updated: July 24, 2012
Last verified: July 2012
| Tracking Information | |||||
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| First Received Date ICMJE | December 19, 2010 | ||||
| Last Updated Date | July 24, 2012 | ||||
| Start Date ICMJE | December 2008 | ||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR [ Time Frame: At week 48 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01264367 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Evaluate the Efficacy and Safety of Clevudine and Peg-interferon in Sequence Compared With Clevudine Alone in the Patients With HBeAg(+) Chronic Hepatitis B or Clevudine and Peg-interferon Sequential Treatment in Patients With Chronic Hepatitis B Who Have HBeAg(+) | ||||
| Official Title ICMJE | A Study to Evaluate the Efficacy and Safety of Clevudine and Peg-interferon in Sequence Compared With Clevudine Alone in the Patients With HBeAg(+) Chronic Hepatitis B or Clevudine and Peg-interferon Sequential Treatment in Patients With Chronic Hepatitis B Who Have HBeAg(+) | ||||
| Brief Summary | A study to evaluate the efficacy and safety of clevudine and peg-interferon in sequence compared with clevudine alone in the patients with HBeAg(+) chronic Hepatitis B or clevudine and peg-interferon sequential treatment in patients with chronic Hepatitis B who have HBeAg(+) |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | HBeAg(+) Chronic Hepatitis B | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01264367 | ||||
| Other Study ID Numbers ICMJE | CMC-403, CMC-403 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Bukwang Pharm.CO.,LTD | ||||
| Study Sponsor ICMJE | Bukwang Pharmaceutical | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bukwang Pharmaceutical | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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