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 currently recruiting participants.

Verified May 2012 by Hoffmann-La Roche

First Received on June 16, 2009. Last Updated on May 21, 2012 History of Changes

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00927082

Purpose

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.

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Peginterferon Alfa-2a

U.S. FDA Resources

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 ]

Estimated Enrollment:	471
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2015

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

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

Contacts

Contact: Please reference Study ID Number: MV22430

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Show 31 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00927082 History of Changes
Other Study ID Numbers:	MV22430
Study First Received:	June 16, 2009
Last Updated:	May 21, 2012
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 May 23, 2012