PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)

March 9, 2017 updated by: Merck Sharp & Dohme LLC

An Open-label, Randomized Study of PegIntron in the Treatment of HBeAg Positive Chronic Hepatitis B Patients

The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks. This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks after their treatment ends.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
671

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults with chronic hepatitis B:

    • Serum hepatitis B surface antigen positive for at least 6 months
    • Serum hepatitis B e antigen positive
    • Serum negative for hepatitis B surface and e antibodies
    • Plasma hepatitis B virus deoxyribonucleic acid (DNA) level greater than 20,000 IU/mL
    • Alanine aminotransferase (ALT) 2- to 10-times the upper limit of normal
  • Compensated liver disease with certain minimum hematological and serum biochemical criteria

Exclusion Criteria:

  • Significant hepatic disease from an etiology other than hepatitis B virus
  • Antiviral treatment for hepatitis within previous 6 months
  • History of severe psychiatric disease, especially depression
  • Unstable or significant cardiovascular disease
  • Prolonged exposure to known hepatotoxins such as alcohol or drugs
  • Any condition that could interfere with the subject participating in and completing the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: PEG 1.0 mcg/kg weekly (QW) * 24 weeks
PegIntron 1.0 mcg/kg weekly (QW) * 24 weeks + 24 weeks follow-up
Drug: pegylated interferon alpha-2b
1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks
Drug: pegylated interferon alpha-2b
1.5 mcg/kg S.C. QW for 24 weeks
Drug: pegylated interferon alpha-2b
1.5 mcg/kg S.C. QW for 48 weeks
Experimental: PEG 1.5 mcg/kg QW * 24 wks
PegIntron 1.5 mcg/kg QW * 24 wks + 24 wks follow-up
Drug: pegylated interferon alpha-2b
1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks
Drug: pegylated interferon alpha-2b
1.5 mcg/kg S.C. QW for 24 weeks
Drug: pegylated interferon alpha-2b
1.5 mcg/kg S.C. QW for 48 weeks
Experimental: PEG 1.5 mcg/kg QW * 48 wks
PegIntron 1.5 mcg/kg QW * 48 wks + 24 wks follow-up
Drug: pegylated interferon alpha-2b
1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks
Drug: pegylated interferon alpha-2b
1.5 mcg/kg S.C. QW for 24 weeks
Drug: pegylated interferon alpha-2b
1.5 mcg/kg S.C. QW for 48 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss
Time Frame: 24 weeks after end of treatment (EOT)
HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)
24 weeks after end of treatment (EOT)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With HBeAg Loss
Time Frame: Up to Treatment Week 48
HBeAg Loss was tested by assay of Abbott MEIA
Up to Treatment Week 48
HBe Seroconversion
Time Frame: End of treatment (EOT) and 24 weeks after EOT
HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA.
End of treatment (EOT) and 24 weeks after EOT
Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL
Time Frame: End of treatment (EOT) and 24 weeks after EOT

HBV-DNA was tested by assay of Roche Cobas Taqman (the test

lowest limit is 6 IU/mL)
End of treatment (EOT) and 24 weeks after EOT
Number of Participants With HBV-DNA < 200 IU/mL
Time Frame: End of treatment (EOT) and 24 weeks after EOT
HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)
End of treatment (EOT) and 24 weeks after EOT
Number of Participants With HBV-DNA Undetectable
Time Frame: End of treatment (EOT) and 24 weeks after EOT
Undetectable HBV-DNA was defined as having a level <6 IU/mL by polymerase chain reaction (PCR).
End of treatment (EOT) and 24 weeks after EOT
Number of Participants With Biochemical Response
Time Frame: End of treatment (EOT) and 24 weeks after EOT
Biochemical response was defined as alanine aminotransferase (ALT) normalization.
End of treatment (EOT) and 24 weeks after EOT
Number of Participants With Combined Response
Time Frame: End of treatment (EOT) and 24 weeks after EOT
Combined response was defined as HBV DNA <20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization
End of treatment (EOT) and 24 weeks after EOT
Hepatitis B Surface Antigen (HBsAg) Loss
Time Frame: End of treatment (EOT) and 24 weeks after EOT
HBsAg Loss was tested by assay of Abbott MEIA
End of treatment (EOT) and 24 weeks after EOT
Hepatitis B Surface Antigen (HBs) Seroconversion
Time Frame: End of treatment (EOT) and 24 weeks after EOT
HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive
End of treatment (EOT) and 24 weeks after EOT
Change From Baseline in Liver Biopsy Score
Time Frame: Baseline to 24 weeks after end of treatment

Method for biopsy scoring was Knodell Scoring System (Histology Activity Index-HAI Score System):

Score I (periportal +/- bridging necrosis): 0 (none) to 10 (multilobular necrosis).

Score II (Intralobular degeneration and focal necrosis): 0 (none) to 4 (Marked [involvement of >2/3 of lobules or nodules]).

Score III (portal inflammation): 0 (none) to 4 (Marked [dense packing of

inflammatory cells in >2/3 of portal tracts]).

Score IV (fibrosis): 0 (none) to 4 (cirrhosis).
Baseline to 24 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P05170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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