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: August 26, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Hepatitis B, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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).

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • HBV DNA, ALT, HBsAg, anti-HBs, HBeAg, anti-HBe, quantitative HBsAg [ Time Frame: Annually, for up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 383
Study Start Date: April 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • as for WV19432
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927082

  Hide Study Locations
Locations
Australia, Victoria
Fitzroy, Victoria, Australia, 3065
Brazil
Salvador, BA, Brazil, 40210-341
Campinas, SP, Brazil, 13083-888
Ribeirao Preto, SP, Brazil, 14049-900
Santo Andre, SP, Brazil, 09060-650
Sao Paulo, SP, Brazil, 05403-000
China
Beijing, China, 100054
Beijing, China, 100050
Chang Sha, China, 410008
Guangzhou, China, 510630
Shanghai, China, 200025
Shanghai, China, 201508
Hong Kong
Hong Kong, Hong Kong
Hong Kong, Hong Kong, 852
Korea, Republic of
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 120-752
New Zealand
Auckland, New Zealand, 100
Hamilton, New Zealand
Russian Federation
Samara, Russian Federation, 443100
St Petersburg, Russian Federation, 190103
Stavropol, Russian Federation, 355017
Singapore
Singapore, Singapore, 169608
Taiwan
Kaohsiung, Taiwan, 807
Taipei, Taiwan, 100
Taoyuan, Taiwan, 333
Thailand
Bangkok, Thailand, 10400
Bangkok, Thailand, 10700
Chiang Mai, Thailand, 50202
Khon Kaen, Thailand, 40002
Songkhla, Thailand, 90112
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00927082     History of Changes
Other Study ID Numbers: MV22430
Study First Received: June 16, 2009
Last Updated: August 26, 2014
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014