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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00614471
First received: January 30, 2008
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms s.c./week for 48 weeks, 2)PEGASYS 180 micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36 or 3) entecavir 0.5mg p.o. once daily for 24 weeks + PEGASYS 180 micrograms s.c./week from week 21 to 68. Treatment will be followed by 24 weeks treatment-free follow up. The anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for group 3, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Hepatitis B, Chronic
 Drug: peginterferon alfa-2a [Pegasys]
Drug: Entecavir
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Study of the Effect of Peginterferon Alfa-2a (40KD) (PEGASYS®) Plus Entecavir (Baraclude®) Combination Therapy on Quantitative Changes in HBeAg in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Log change in quantitative HBeAg from baseline to 24 weeks after end of treatment. [ Time Frame: Week 72 for Arms 1 and 2. Week 92 for Arm 3. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HBeAg seroconversion, HBV-DNA <1000 copies/mL, loss of HBeAg, HBV DNA reduction, ALT normalization, loss of HBsAg seroconversion, reduction of HBsAg 24 weeks after end of treatment. [ Time Frame: Week 72 for Arms 1 and 2. Week 92 for Arm 3. ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 219
Study Start Date: August 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc/week for 48 weeks
Experimental: 2 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc/week for 48 weeks
Drug: Entecavir
0.5mg po daily from week 13 to week 36
Experimental: 3 Drug: Entecavir
0.5mg po daily for 24 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc/week from week 21 to week 68

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-65 years of age;
  • HBsAg positive, HBeAg positive and anti-HBe negative for at least 6 months, anti-HBs negative;
  • absence of cirrhosis confirmed by liver biopsy in previous 12 months.

Exclusion Criteria:

  • previous treatment for chronic hepatitis B within previous 6 months;
  • antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months;
  • co-infection with active hepatitis A, hepatitis C, hepatitis D or HIV;
  • history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614471

Locations
China
Beijing, China, 100011
Hangzhou, China, 310003
Shanghai, China, 200025
Shanghai, China, 200021
Shanghai, China, 450052
Xi'an, China, 710038
Zhengzhou, China, 450052
Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00614471     History of Changes
Other Study ID Numbers: ML20742
Study First Received: January 30, 2008
Last Updated: June 3, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Peginterferon alfa-2a
Interferon-alpha
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013