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A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)

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ClinicalTrials.gov Identifier: NCT02604823
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Peginterferon alfa-2a Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (Pegasys®) in Patients With HBeAg-Positive Chronic Hepatitis B
Study Start Date : November 2003
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A (Naïve Participants)
Participants who never received any HBV treatment, will receive peginterferon alfa-2a (180 micrograms [mcg]) subcutaneously once weekly for 48 weeks.
Drug: Peginterferon alfa-2a
Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.
Other Name: Pegasys

Experimental: Group B (Conventional Interferon Pretreated Participants)
Participants who received conventional interferon treatment and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.
Drug: Peginterferon alfa-2a
Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.
Other Name: Pegasys

Experimental: Group C (Lamivudine Pretreated Participants)
Participants who received lamivudine and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.
Drug: Peginterferon alfa-2a
Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.
Other Name: Pegasys




Primary Outcome Measures :
  1. Percentage of participants with HBV deoxyribonucleic acid (DNA) less than (<) 100,000 copies per milliliters (copies/mL) [ Time Frame: 72 weeks ]
  2. Percentage of participants with HBeAg seroconversion [ Time Frame: 72 weeks ]

Secondary Outcome Measures :
  1. Number of participants who achieved HBV DNA levels below limit of detection [ Time Frame: Weeks 48 and 72 ]
  2. Number of participants with HBsAg loss [ Time Frame: Weeks 48 and 72 ]
  3. Number of participants with both Hepatitis B Surface Antigen (HBsAg) loss and presence of Anti-HBs [ Time Frame: Weeks 48 and 72 ]
  4. Number of participants with alanine aminotransferase (ALT) normalization [ Time Frame: Weeks 48 and 72 ]
  5. Number of participants with combined response (HBV DNA <100,000 copies/mL, HBeAg loss, and ALT normalization) [ Time Frame: Weeks 48 and 72 ]
  6. Incidence of adverse events [ Time Frame: up to 72 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult participants between 18 to 65 years of age
  • HBeAg-positive chronic HBV
  • Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.

Exclusion Criteria:

  • Antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment
  • Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV)
  • Evidence of decompensated liver disease
  • Medical condition associated with chronic liver disease other than viral hepatitis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604823


Locations
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China
Beijing, China, 100011
Guangzhou, China, 510630
Shanghai, China, 200025
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02604823     History of Changes
Other Study ID Numbers: ML17700
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs