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Entecavir and Pegasys Sequential Therapy Versus Pegasys for HBeAg Negative Chronic Hepatitis B

NCT ID: NCT00917761

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2013-12-31

Brief Summary

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Currently, peginterferon alfa-2a or oral nucleos(t)ides are approved for the treatment with HBeAg negative CHB, with the overall ALT normalization and HBV viral suppression far from satisfactory. Therefore, efforts on the various combinations with the currently available drugs are needed to improve the overall response rates. The simultaneous combination therapy with oral nucleoside and peginterferon alfa-2a from large-scaled randomized trials did not show a superior response rate over peginterferon alfa-2a monotherapy. Recently, sequential monotherapy with lamivudine for the first 4 weeks, followed by weekly peginterferon alfa-2a has shown favorable HBeAg seroconversion rate over peginterferon alfa-2a monotherapy, based on the assumption that early viral suppression by lamivudine can restore the immune function to facilitate the later immunomodulatory response by peginterferon alfa-2a. Furthermore, prior studies using 24 months of standard interferon alfa showed better ALT normalization and HBV suppression rates to 12 months of therapy. With the recent introduction of entecavir, the more potent oral nucleoside with few drug resistance, sequential monotherapy with entecavir can potently suppress HBV DNA with 4 weeks of treatment, which may facilitate the response of peginterferon alfa-2a to achieve HBV viral suppression. Therefore, we aimed to conduct a placebo controlled randomized control trial to evaluate if adding entecavir early in the course of therapy or extending the treatment duration of peginterferon alfa-2a can improve the treatment response.

Detailed Description

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Chronic hepatitis B (CHB) is prevalent in the world, with estimated chronic carriers of 350 millions worldwide. Currently, peginterferon alfa-2a or oral nucleos(t)ides are approved for the treatment with HBeAg negative CHB, with the overall ALT normalization and HBV viral suppression far from satisfactory. Therefore, efforts on the various combinations with the currently available drugs are needed to improve the overall response rates. The simultaneous combination therapy with oral nucleoside and peginterferon alfa-2a from large-scaled randomized trials did not show a superior response rate over peginterferon alfa-2a monotherapy. Recently, sequential monotherapy with lamivudine for the first 4 weeks, followed by weekly peginterferon alfa-2a has shown favorable HBeAg seroconversion rate over peginterferon alfa-2a monotherapy, based on the assumption that early viral suppression by lamivudine can restore the immune function to facilitate the later immunomodulatory response by peginterferon alfa-2a. Furthermore, prior studies using 24 months of standard interferon alfa showed better ALT normalization and HBV suppression rates to 12 months of therapy. With the recent introduction of entecavir, the more potent oral nucleoside with few drug resistance, sequential monotherapy with entecavir can potently suppress HBV DNA with 4 weeks of treatment, which may facilitate the response of peginterferon alfa-2a to achieve HBV viral suppression. Therefore, we aimed to conduct a placebo controlled randomized control trial to evaluate if adding entecavir early in the course of therapy or extending the treatment duration of peginterferon alfa-2a can improve the treatment response.

Conditions

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Hepatitis B, Chronic

Keywords

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Hepatitis B, chronic Peginterferon alfa-2a Entecavir

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Entecavir and peginterferon (52 weeks)

Entecavir 0.5 mg/day po at week 1-4 Peginterferon alfa-2a 180 ug/week sc at week 5-52

Group Type EXPERIMENTAL

Entecavir and peginterferon (Pegasys) (52 weeks)

Intervention Type DRUG

Entecavir 0.5 mg/day po at week 1-4 Peginterferon alfa-2a 180 ug/week sc at week 5-52

Peginterferon (96 weeks)

Peginterferon alfa-2a 180 ug/week sc at week 1-96

Group Type EXPERIMENTAL

Peginterferon (Pegasys) (96 weeks)

Intervention Type DRUG

Peginterferon alfa-2a 180 ug/week sc at week 1-96

Peginterferon (48 weeks)

Peginterferon alfa-2a 180 ug/week sc at week 1-48

Group Type ACTIVE_COMPARATOR

Peginterferon (Pegasys) (48 weeks)

Intervention Type DRUG

Peginterferon alfa-2a 180 ug/week sc at week 1-48

Interventions

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Entecavir and peginterferon (Pegasys) (52 weeks)

Entecavir 0.5 mg/day po at week 1-4 Peginterferon alfa-2a 180 ug/week sc at week 5-52

Intervention Type DRUG

Peginterferon (Pegasys) (96 weeks)

Peginterferon alfa-2a 180 ug/week sc at week 1-96

Intervention Type DRUG

Peginterferon (Pegasys) (48 weeks)

Peginterferon alfa-2a 180 ug/week sc at week 1-48

Intervention Type DRUG

Other Intervention Names

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Entecavir (Baraclude)0.5 mg/day po at week 1-4 Peginterferon alfa-2a (Pegasys) 180 ug/week sc at week 5-52 Peginterferon alfa-2a (Pegasys) 180 ug/week sc at week 1-96 Peginterferon alfa-2a (Pegasys) 180 ug/week sc at week 1-48

Eligibility Criteria

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Inclusion Criteria

* Chronic hepatitis B (presence of HBsAg \> 6 months) with anti-HBe persistence and abscence of HBeAg for more than 3 months
* Age older than 18 years
* HBV DNA \> 2,000 IU/mL for more than 2 occasions
* Serum ALT levels between 2 to 10 folds the upper limit of normal (ULN)
* A liver biopsy compatible with chronic hepatitis B

Exclusion Criteria

* Anemia (hemoglobin \< 13 gram per deciliter for men and \< 12 gram per deciliter for women)
* Neutropenia (neutrophil count \<1,500 per cubic milliliter)
* Thrombocytopenia (platelet \<90,000 per cubic milliliter)
* Co-infection with hepatitis B virus (HBV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
* Chronic alcohol abuse (daily consumption \> 20 gram per day)
* Decompensated liver disease (Child-Pugh class B or C)
* Serum creatinine level more than 1.5 times the upper limit of normal
* Autoimmune liver disease
* Neoplastic disease
* An organ transplant
* Immunosuppressive therapy
* Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
* Evidence of drug abuse
* Unwilling to have contraception
* Known allergic reaction to entecavir or peginterferon alfa-2a
* Unwilling to sign inform consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chen-Hua Liu, MD

Role: STUDY_CHAIR

National Taiwan University Hospital

Jia-Horng Kao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Shih-Jer Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hosptial, Yun-Lin Branch

Chih-Lin Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Ren-Ai Branch, Taipei City Hospital

Cheng-Chao Liang, MD

Role: PRINCIPAL_INVESTIGATOR

Far Eastern Memorial Hospital

Ching-Sheng Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Buddhist Tzu Chi General Hospital

Sheng-Shun Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Locations

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National Taiwan University Hosptial, Yun-Lin Branch

Douliu, , Taiwan

Site Status RECRUITING

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Buddhist Tzu Chi General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Far Eastern Memorial Hospital

Taipei, , Taiwan

Site Status RECRUITING

Ren-Ai Branch, Taipei Municipal Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chen-Hua Liu, MD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Jia-Horng Kao, MD, PhD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Shih-Jer Hsu, MD

Role: primary

Sheng-Shun Yang, MD, PhD

Role: primary

Chen-Hua Liu, MD

Role: primary

Ching-Sheng Hsu, MD

Role: primary

Cheng-Chao Liang, MD

Role: primary

Chih-Lin Lin, MD

Role: primary

Other Identifiers

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950924

Identifier Type: -

Identifier Source: org_study_id