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  ICMJEApril 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  ICMJESame as current
Change HistoryComplete 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  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA 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  ICMJEA 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 PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJEOther, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJEHepatitis B, Chronic
Intervention  ICMJEDrug: 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 Groups1: Experimental
Intervention: Drug: peginterferon alfa-2a (40KD)[PEGASYS]

Recruitment Information

Estimated Enrollment  ICMJE471
Estimated Completion DateNovember 2015
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients who have completed treatment and follow-up on study WV19432

Exclusion Criteria:

  • as for WV19432
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: MV22430888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEAustralia,   Brazil,   China,   Hong Kong,   Korea, Republic of,   New Zealand,   Russian Federation,   Singapore,   Taiwan,   Thailand

Administrative Information

NCT ID  ICMJENCT00927082
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEMV22430
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche