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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00927082
First received: June 16, 2009
Last updated: September 22, 2014
Last verified: September 2014

June 16, 2009
September 22, 2014
April 2009
November 2014   (final data collection date for primary outcome measure)
HBV DNA, ALT, HBsAg, anti-HBs, HBeAg, anti-HBe, quantitative HBsAg [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00927082 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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
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).

This study is a long-term post-treatment follow-up to study WV19432, which evalu ated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and completed fo llow-up, are eligible to enter this post-treatment follow-up study. The anticipa ted time on study is 2+ years, and the target sample size is 100-500 individuals

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Hepatitis B, Chronic
Drug: peginterferon alfa-2a [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)
Experimental: 1
Intervention: Drug: peginterferon alfa-2a [Pegasys]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
383
November 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • as for WV19432
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   China,   Hong Kong,   Korea, Republic of,   New Zealand,   Russian Federation,   Singapore,   Taiwan,   Thailand
 
NCT00927082
MV22430
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP