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

NCT00927082 | Completed Phase 4 Results

• 1 other identifier: MV22430
• Study Type: interventional
• Target: 383
• Locations: 10 countries
• Sites: 31

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

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.

  HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response.

  Annually, for up to 5 years

• Percentage of Participants With HBsAg Loss

  HBsAg loss is defined as the absence of HBsAg (i.e. a negative result for HBsAg). Missing values were counted as non-response.

  Annually, for up to 5 years

Secondary Outcomes (12)

• Percentage of Participants With HBeAg Loss.

  Annually, for up to 5 years

• Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.

  Annually, for up to 5 years

• Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).

  Annually, for up to 5 years

• Percentage of Participants With Presence of Anti-HBs

  Annually, for up to 5 years

• Percentage of Participants With Normalised Alanine Transaminase (ALT)

  Annually, for up to 5 years

Study Arms (4)

PEG-IFN 90mcg 24 Wks

EXPERIMENTAL

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.

Drug: peginterferon alfa-2a [Pegasys]

PEG-IFN 180mcg 24 Wks

EXPERIMENTAL

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

Drug: peginterferon alfa-2a [Pegasys]

PEG-IFN 90mcg 48 Wks

EXPERIMENTAL

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

Drug: peginterferon alfa-2a [Pegasys]

PEG-IFN 180mcg 48 Wks

EXPERIMENTAL

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

Drug: peginterferon alfa-2a [Pegasys]

Interventions

peginterferon alfa-2a [Pegasys] 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; PEG-IFN 180mcg 48 Wks; PEG-IFN 90mcg 24 Wks; PEG-IFN 90mcg 48 Wks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• As for Study WV19432

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (31)

Unknown Facility

Fitzroy, Victoria, 3065, Australia

Location

Unknown Facility

Salvador, Estado de Bahia, 40210-341, Brazil

Location

Unknown Facility

Campinas, São Paulo, 13083-888, Brazil

Location

Unknown Facility

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Unknown Facility

Santo André, São Paulo, 09060-650, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 05403-000, Brazil

Location

Unknown Facility

Beijing, 100050, China

Location

Unknown Facility

Beijing, 100054, China

Location

Unknown Facility

Changsha, 410008, China

Location

Unknown Facility

Guangzhou, 510630, China

Location

Unknown Facility

Shanghai, 200025, China

Location

Unknown Facility

Shanghai, 201508, China

Location

Unknown Facility

Hong Kong, 852, Hong Kong

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Auckland, 100, New Zealand

Location

Unknown Facility

Hamilton, New Zealand

Location

Unknown Facility

Saint Petersburg, 190103, Russia

Location

Unknown Facility

Samara, 443100, Russia

Location

Unknown Facility

Stavropol, 355017, Russia

Location

Unknown Facility

Singapore, 169608, Singapore

Location

Unknown Facility

Seoul, 110-744, South Korea

Location

Unknown Facility

Seoul, 120-752, South Korea

Location

Unknown Facility

Seoul, 138-736, South Korea

Location

Unknown Facility

Kaohsiung City, 807, Taiwan

Location

Unknown Facility

Taipei, 100, Taiwan

Location

Unknown Facility

Taoyuan District, 333, Taiwan

Location

Unknown Facility

Bangkok, 10400, Thailand

Location

Unknown Facility

Bangkok, 10700, Thailand

Location

Unknown Facility

Chiang Mai, 50202, Thailand

Location

Unknown Facility

Khon Kaen, 40002, Thailand

Location

Unknown Facility

Songkhla, 90112, Thailand

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Of the responders at FU Year 5, the proportion of patients who were receiving additional anti-HBV treatment after FU Week 24 varied between groups. The frequency of missing values (counted as non-response) was unevenly distributed between groups.

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 24, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 9, 2016
• Results First Posted: March 9, 2016

Record last verified: 2016-02

Locations

CN (6); SG (1); HK (2); TH (5); NZ (2); RU (3); BR (5); KR (3); TW (3); AU (1)