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A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B

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ClinicalTrials.gov Identifier: NCT02598063
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target sample size is 255 individuals.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study Evaluating the Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) or Adefovir Dipivoxil (ADV) in Patients With Lamivudine-resistant HBeAg Positive Chronic Hepatitis B
Study Start Date : October 2005
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ADV + Lamivudine
Participants will receive ADV and lamivudine tablets at a dose of 10 mg orally QD for first 12 weeks followed by ADV for 60 weeks.
Drug: Adefovir dipivoxil
ADV will be administered orally at a dose of 10 mg QD for 72 weeks.

Drug: Lamivudine
Lamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks.

Experimental: Peginterferon alfa-2a + Lamivudine
Participants will receive peginterferon alfa-2a injection at a dose of 180 micrograms (mcg) once weekly (QW) and 100 milligrams (mg) lamivudine tablets orally once daily (QD) for first 12 weeks followed by peginterferon alfa-2a for 36 weeks.
Drug: Lamivudine
Lamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks.

Drug: Peginterferon alfa-2a
Peginterferon alfa-2a injection will be administered at a dose of 180 mcg QW for 48 weeks.
Other Name: Pegasys




Primary Outcome Measures :
  1. HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at Week 72 [ Time Frame: Week 72 ]

Secondary Outcome Measures :
  1. Loss of HBeAg [ Time Frame: Week 48, and 72 ]
  2. Reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA) [ Time Frame: Week 48, and 72 ]
  3. Alanine transaminase (ALT) normalization [ Time Frame: Week 48, and 72 ]
  4. Hepatitis B surface antigen (HBsAg) seroconversion [ Time Frame: Week 48, and 72 ]


Information from the National Library of Medicine

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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 18-65 years of age
  • Hepatitis B surface antigen (HBsAg)-positive, HBeAg-positive, and anti-HBs-negative for greater than or equal to (>=) 6 months
  • Receiving lamivudine currently, and for >=6 months
  • hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) decreased >=2 log during lamivudine treatment on >=1 occasion
  • Absence of cirrhosis confirmed by liver biopsy in previous 6 months

Exclusion Criteria:

  • Other drugs with activity against HBV within the prior 6 months, except lamivudine
  • Antiviral, anti-neoplastic, or immunomodulatory therapy less than or equal to (<=) 6 months before study - Active infection with hepatitis A, C, or D virus, or human immunodeficiency virus
  • Decompensated liver disease
  • Medical condition associated with another chronic liver disease

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): NCT02598063


Locations
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China
Beijing, China, 100044
Beijing, China, 100050
Beijing, China, 100054
Chongqing, China, 400038
Guangzhou, China, 510515
Hangzhou, China, 310003
Jinan, China, 250021
Shanghai, China, 200025
Shanghai, China, 200040
Shanghai, China, 201508
Hong Kong
Hong Kong, Hong Kong, 852
Hong Kong, Hong Kong
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: NCT02598063     History of Changes
Other Study ID Numbers: ML18376
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
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Lamivudine
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Adefovir
Adefovir dipivoxil
Peginterferon alfa-2a
Interferon-alpha
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Immunologic Factors
Physiological Effects of Drugs