NCT02791269

Brief Summary

This is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen (HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48 weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free follow-up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2006

Typical duration for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

February 6, 2017

Completed
Last Updated

February 6, 2017

Status Verified

December 1, 2016

Enrollment Period

2.5 years

First QC Date

May 31, 2016

Results QC Date

August 26, 2016

Last Update Submit

December 13, 2016

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (2)

  • Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL)

    HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests.

    End of 24-weeks follow-up (Week 72)

  • Number of Participants With HBV-DNA <20,000 Copies/mL

    HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.

    End of 24-weeks follow-up (Week 72)

Secondary Outcomes (4)

  • Number of Participants With HBV-DNA <400 Copies/mL

    Week 48 (end of treatment) and Week 72 (end of follow-up)

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

    Week 48 (end of treatment) and Week 72 (end of follow-up)

  • Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level

    Week 48 (end of treatment) and Week 72 (end of follow-up)

  • Number of Participants With HBeAg Seroconversion

    Week 48 (end of treatment) and Week 72 (end of follow-up)

Study Arms (2)

HBeAg Negative Participants

EXPERIMENTAL

HBeAg negative participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period.

Drug: Peginterferon alfa-2a

HBeAg Positive Participants

EXPERIMENTAL

HBeAg Positive participants will receive peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.

Drug: Peginterferon alfa-2a

Interventions

Peginterferon alfa-2aDRUG

180 mcg SC injection QW for 48 weeks.

Also known as: Pegasys
HBeAg Negative ParticipantsHBeAg Positive Participants

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-cirrhotic participants
  • Hepatitis B surface antigen (HBsAg) positive for at least 6 months
  • Hepatitis B surface antibody (anti-HBs) negative
  • Elevated serum alanine aminotransferase (ALT) greater than (\>) upper limit of normal (ULN) but less than or equal to (\</=) 10 times of ULN
  • HBeAg positive participants: HBV DNA \> 500,000 copies/mL, HBeAg negative participants: HBV DNA \>100,000 copies/mL by polymerase chain reaction (PCR)
  • Participants with chronic hepatitis B (CHB) who are treatment-naive
  • No previous antiviral treatment with interferon (IFN: standard or pegylated) or with a nucleoside analogue
  • For women of childbearing potential: negative urine or serum pregnancy test documented within the 24-hour period prior to the first dose of test drug. Willingness to use reliable contraception during the study and for 3 months after treatment completion

You may not qualify if:

  • Previous antiviral or IFN-based therapy for CHB before enrolment
  • Pregnant or breast feeding women participants
  • Evidence of decompensated liver disease
  • Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV)
  • History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis
  • Previous or current hepatocellular carcinoma
  • History of or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
  • Alpha-fetoprotein levels of \>100 nanograms (ng)/mL
  • Severe psychiatric disease
  • History of a severe seizure disorder or current anticonvulsant use
  • History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the participant, in the opinion of the investigator, unsuitable for the study
  • Thyroid disease uncontrolled by prescribed medications
  • Evidence of severe retinopathy
  • Alcohol intake more than 3 standard drinks per day for men and 2 standard drinks per day for women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Auckland, New Zealand

Location

Unknown Facility

Hamilton, New Zealand

Location

Unknown Facility

New Plymouth, New Zealand

Location

Unknown Facility

Riccarton, Christchurch, 8011, New Zealand

Location

Unknown Facility

Rotorua, New Zealand

Location

Unknown Facility

Whangarei, New Zealand

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon 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
Medical Communications
Organization
Hoffmann-LaRoche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 6, 2016

Study Start

January 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

February 6, 2017

Results First Posted

February 6, 2017

Record last verified: 2016-12

Locations

NZ(6)