A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B
Tracking Information
| Start Date ICMJE | April 2009 |
|---|---|
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE (submitted: June 23, 2009) | HBV DNA, ALT, HBsAg, anti-HBs, HBeAg, anti-HBe, quantitative HBsAg [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00927082 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE (submitted: June 23, 2009) | Clinical events related to chronic hepatitis B; laboratory parameters; concomitant medications; adverse events [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
| Brief Title ICMJE | A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B |
|---|---|
| Official Title ICMJE | A Follow-up Study to Evaluate the Long-term Post Treatment Effects of Peginterferon Alfa-2a (PEG-IFN) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study WV19432(NEPTUNE). |
| Brief Summary | This study is a long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to enter this post-treatment follow-up study. The anticipated time on study is 2+ years, and the target sample size is 100-500 individuals. |
| Detailed Description | |
| Study Phase | Phase IV |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Other, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Condition ICMJE | Hepatitis B, Chronic |
| Intervention ICMJE | Drug: peginterferon alfa-2a (40KD)[PEGASYS] 90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No treatment in long-term post-treatment follow-up study (MV22430) |
| Study Arms / Comparison Groups | 1: Experimental Intervention: Drug: peginterferon alfa-2a (40KD)[PEGASYS] |
Recruitment Information
| Estimated Enrollment ICMJE | 471 | ||||
|---|---|---|---|---|---|
| Estimated Completion Date | November 2015 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
| ||||
| Location Countries ICMJE | Australia, Brazil, China, Hong Kong, Korea, Republic of, New Zealand, Russian Federation, Singapore, Taiwan, Thailand |
Administrative Information
| NCT ID ICMJE | NCT00927082 | ||||
|---|---|---|---|---|---|
| Responsible Party | Disclosures Group, Hoffmann-La Roche | ||||
| Study ID Numbers ICMJE | MV22430 | ||||
| Study Sponsor ICMJE | Hoffmann-La Roche | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
| ||||
| Information Provided By | Hoffmann-La Roche |
Source: http://clinicaltrials.gov/