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

NCT ID: NCT00927082

Last Updated: 2016-03-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

383 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2014-11-30

Brief Summary

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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 was 5 years, and the target sample size is 100-500 individuals.

Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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PEG-IFN 90mcg 24 Wks

Participants received Pegasys (Pegylated interferon alfa-2a \[PEG-IFN\]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.

Group Type EXPERIMENTAL

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)

PEG-IFN 180mcg 24 Wks

Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.

Group Type EXPERIMENTAL

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)

PEG-IFN 90mcg 48 Wks

Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.

Group Type EXPERIMENTAL

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)

PEG-IFN 180mcg 48 Wks

Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.

Group Type EXPERIMENTAL

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)

Interventions

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peginterferon alfa-2a [Pegasys]

90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent for Study WV19432
* Patients who have completed treatment and follow-up on study WV19432

Exclusion Criteria

* As for Study WV19432
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Fitzroy, Victoria, Australia

Site Status

Salvador, Estado de Bahia, Brazil

Site Status

Campinas, São Paulo, Brazil

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Ribeirão Preto, São Paulo, Brazil

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Santo André, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Beijing, , China

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Beijing, , China

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Changsha, , China

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Guangzhou, , China

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Shanghai, , China

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Shanghai, , China

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Hong Kong, , Hong Kong

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Hong Kong, , Hong Kong

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Auckland, , New Zealand

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Hamilton, , New Zealand

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Saint Petersburg, , Russia

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Samara, , Russia

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Stavropol, , Russia

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Singapore, , Singapore

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Kaohsiung City, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Bangkok, , Thailand

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Khon Kaen, , Thailand

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Songkhla, , Thailand

Site Status

Countries

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Australia Brazil China Hong Kong New Zealand Russia Singapore South Korea Taiwan Thailand

Other Identifiers

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MV22430

Identifier Type: -

Identifier Source: org_study_id

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