NCT01641926

Brief Summary

This study is being done to compare the safety and efficacy of PEG-Intron™ to that of PEGASYS™ in participants with chronic hepatitis B (hepatitis B envelope antigen \[HBeAg\] positive or negative) who have not previously been treated with interferon.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2012

Typical duration for phase_3

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

November 26, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 12, 2017

Completed
Last Updated

August 27, 2018

Status Verified

July 1, 2018

Enrollment Period

3.2 years

First QC Date

July 11, 2012

Results QC Date

November 16, 2016

Last Update Submit

July 27, 2018

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (2)

  • Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment

    Blood samples were drawn to assess the participant's seroconversion status at Follow-up (FU) Week 24. HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg.

    FU Week 24 (Study Week 72)

  • Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment

    The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(-) participants. The percentage of HBeAg(-) participants with HBV DNA \<2000 IU/mL at 24 weeks post-treatment was reported.

    FU Week 24 (Study Week 72)

Secondary Outcomes (3)

  • Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment

    FU Week 24 (Study Week 72)

  • Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment

    FU Week 24 (Study Week 72)

  • Percentage of HBeAg(+) Participants Achieving the Combined Response of HBeAg Seroconversion and HBV DNA <2000 IU/mL at 24 Weeks Post-treatment

    FU Week 24 (Study Week 72)

Study Arms (4)

HBeAg(+) PEG-Intron

EXPERIMENTAL

HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.

Biological: PEG-Intron™

HBeAg(+) PEGASYS

ACTIVE COMPARATOR

HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.

Biological: PEGASYS™

HBeAg(-) PEG-Intron

EXPERIMENTAL

HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.

Biological: PEG-Intron™

HBeAG(-) PEGASYS

ACTIVE COMPARATOR

HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.

Biological: PEGASYS™

Interventions

PEG-Intron™BIOLOGICAL

PEG-Intron subcutaneously (SC) once weekly for a total of 48 weeks

Also known as: SCH 054031, Pegylated interferon alfa-2b
HBeAg(+) PEG-IntronHBeAg(-) PEG-Intron
PEGASYS™BIOLOGICAL

PEGASYS subcutaneously (SC) once weekly for a total of 48 weeks

Also known as: Pegylated interferon alfa-2a
HBeAG(-) PEGASYSHBeAg(+) PEGASYS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be able to adhere to dose and visit schedules
  • ≥ 40 kg
  • Hepatitis B surface antigen (HBsAg) positive for at least 6 months
  • Anti-HBs negative
  • Female participants of childbearing potential must agree to use an acceptable
  • method of contraception from at least 2 weeks prior to Day 1 and continue until at least 1 month after last dose of study drug
  • HBeAg(+)
  • Anti-HBe(-)
  • HBeAg(-)
  • Anti-HBe(+)

You may not qualify if:

  • Co-infection with the human immunodeficiency virus (HIV) or hepatitis C or hepatitis D virus
  • Prior treatment with interferon for hepatitis B
  • Use of nucleoside/nucleotide analogues within 6 months of the screening visit or at any time during the study
  • Use of any investigational drug within 30 days of the screening visit
  • Prior treatment with herbal remedies with known hepatotoxicity. All herbal remedies used for hepatitis B treatment must be discontinued before Day 1
  • Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
  • Diabetic and/or hypertensive with clinically significant ocular examination findings
  • History of stroke or transient ischemic attack
  • Immunologically mediated disease (e.g., inflammatory bowel disease \[Crohn's disease, ulcerative colitis\], celiac disease, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, sarcoidosis, severe psoriasis requiring oral or injected treatment, or symptomatic thyroid disorder)
  • Chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis)
  • Current or history of any clinically significant cardiac abnormalities/dysfunction
  • Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
  • Myelodysplastic syndromes
  • Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
  • Pregnant or nursing, or intending to become pregnant during the trial period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2bpeginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Study Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 17, 2012

Study Start

November 26, 2012

Primary Completion

January 21, 2016

Study Completion

January 21, 2016

Last Updated

August 27, 2018

Results First Posted

January 12, 2017

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

More information