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Hepatitis B, ChronicPhase 4NCT00940485

A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B

A Phase 4 study testing entecavir and peginterferon alfa-2a [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
entecavir and peginterferon alfa-2a [Pegasys]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
7 sitesChina
Study dates
Apr 2009to Dec 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients, >=18 and </= 65 years of age
  • HBeAg positive chronic hepatitis B
  • Pre-treatment with entecavir for 9-36 months

Who cannot join

  • Antiviral, antineoplastic or immunomodulatory treatment
  • Co-infection with active hepatitis A, C or D, or HIV
  • Evidence of decompensated liver disease
  • History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Study site

    Changsha, 410008

  • Study site

    Chengdu, 610041

  • Study site

    Fuzhou, 350005

  • Study site

    Guangzhou, 510515

  • Study site

    Hangzhou, 310003

  • Study site

    Wuhan, 430030

  • Study site

    Xi'an, 710038

Other trials in China

About this study

Official title: A Study on Optimizing HBeAg Seroconversion in HBeAg Positive CHB Patients With Combination or Sequential Treatment of Pegylated Interferon Alpha-2a and Entecavir

This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months.

Being tested
entecavir, peginterferon alfa-2a [Pegasys]
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • entecavirDrug

    0.5mg po daily for 8 weeks

  • entecavirDrug

    0.5mg po daily for 48 weeks

  • peginterferon alfa-2a [Pegasys]Drug

    180 micrograms sc/week for 48 weeks

Study groups in NCT00940485
Study groupRoleWhat they receive
Peginterferon alfa-2a + entecavirExperimentalParticipants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks.
Receives: Drug: entecavir; Drug: peginterferon alfa-2a [Pegasys]
EntecavirActive comparatorParticipants received entecavir 0.5 mg orally once daily for 48 weeks.
Receives: Drug: entecavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48

    Hepatitis B envelope Antigen (HBeAg) seroconversion was defined as the absence of HBeAg and the presence of antibody to Hepatitis B envelope antigen (anti-HBe).

    Measured: At Week 48

Secondary outcomes (9)

  1. Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48

    Loss of Hepatitis B Envelope Antigen (HBeAg) is defined as the absence of HBeAg.

    Measured: At Week 48

  2. Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48

    Blood was collected for Hepatitis B Virus - Deoxyribonucleic Acid (HBV -DNA) and was analysed at the central laboratories using the Roche approved polymerase chain reaction (PCR) methodology at Week 48. Percentage of participants with HBV-DNA < 1000 copies/mL was reported.

    Measured: At Week 48

  3. Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48

    Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.

    Measured: At Week 48

  4. Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48

    Hepatitis B Surface Antigen (HBsAg) seroconversion was defined as loss of HBsAg and presence of anti-HBs .(antibody to Hepatitis B surface antigen)

    Measured: At Week 48

  5. Percentage of Participants With Normalized Alanine Aminotransferase at Week 48

    Normalized Alanine Aminotransferase (ALT) is defined as having a baseline ALT value > upper limit of normal (ULN), and a decrease in ALT value to ≤ ULN at the given time point.

    Measured: At Week 48

  6. Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time

    Quantitative hepatitis B envelope antigen (HBeAg) results were analyzed in central lab. Values that were less than lower limit of quantification (LLOQ) had been replaced by LLOQ when analyzed, e.g. <1000 was replaced by 1000 and <0.2 was replaced by 0.2. Quantitative HBeAg value unit was calculated using 'Paul Ehrlich Institute units per millilitre' (PEIU/ml). Change in HBeAg was analysed at Weeks 0, 8, 12, 24, 36, and 48.

    Measured: Up to Week 48

  7. Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time

    Quantitative Hepatitis B Surface Antigen (HBsAg) results were analyzed in central lab. Values that were less than LLOQ had been replaced by LLOQ when analyzed, e.g. <1000 was replaced by 1000 and <0.2 was replaced by 0.2. Quantitative HBsAg calculated using 'International Units Per Millilitre' (IU/mL). Change in HBsAg was analysed at Weeks 0, 8, 12, 24, 36, and 48.

    Measured: Up to Week 48

  8. Number of Participants With Incidence of Adverse Events and Serious Adverse Events

    An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.

    Measured: Up to Week 48

  9. Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event

    Participants with clinically significant laboratory abnormalities which were captured as an AE (at the >=5% threshold) were presented.

    Measured: Up to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00940485
Sponsor's protocol ID
ML22265
Status last verified
Feb 2016
First submitted
16 Jun 2009
Last updated
25 Mar 2016

Publications

  • Yan W, Wu D, Wang X, Chen T, Lai Q, Zheng Q, Jiang J, Hou J, Han M, Ning Q. Upregulation of NKG2C+ natural killer cells, TLR-2 expression on monocytes and downregulation of regulatory T-cells influence PEG-IFN treatment efficacy in entecavir-suppressed patients with CHB. Antivir Ther. 2015;20(6):591-602. doi: 10.3851/IMP2953. Epub 2015 Mar 27.

    PubMed 25814467

  • Ning Q, Han M, Sun Y, Jiang J, Tan D, Hou J, Tang H, Sheng J, Zhao M. Switching from entecavir to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: a randomised open-label trial (OSST trial). J Hepatol. 2014 Oct;61(4):777-84. doi: 10.1016/j.jhep.2014.05.044. Epub 2014 Jun 7.

    PubMed 24915612

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing entecavir and peginterferon alfa-2a [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48 (time frame: At Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00940485, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.

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