A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.

This study has been withdrawn prior to enrollment.
(This study was canceled for operational reasons.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01179594
First received: August 10, 2010
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This randomized, 2 x 2 factorial, parrallel group study will compare the efficac y and safety of 48 versus 96 weeks of peginterferon alfa-2a [Pegasys], with or w ithout entecavir, in patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or entecavir (0,5mg orally daily, group B) duri ng weeks 12-36, or Pegasys (180mcg subcutaneously weekly) for 96 weeks plus plac ebo (group C) or entecavir (group D) during weeks 12-36. Anticipated time on stu dy treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target sample size is <500 patients.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IV, 2x2 Factorial, Double Blind Study of 48 Versus 96 Weeks of PEGASYS 180µg, With or Without 24 Weeks of Entecavir in Adult Patients With HBeAg Negative Chronic Hepatitis B.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml) [ Time Frame: 48 weeks after the end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation early HBsAg response - response end of treatment/follow-up [ Time Frame: every 6 weeks up to week 48, every 12 weeks therafter ] [ Designated as safety issue: No ]

Enrollment: 0
Estimated Study Completion Date: November 2014
Arms Assigned Interventions
Placebo Comparator: A Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 48 weeks
Drug: placebo
orally daily, 24 weeks (weeks 12-36)
Experimental: B Drug: entecavir
0.5 mg orally daily, 24 weeks (weeks 12-36)
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 48 weeks
Placebo Comparator: C Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 96 weeks
Drug: placebo
orally daily, 24 weeks (weeks 12-36)
Experimental: D Drug: entecavir
0.5 mg orally daily, 24 weeks (weeks 12-36)
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 96 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • chronic hepatitis B for >/= 6 months
  • HBeAg negative at screening
  • adequate renal function

Exclusion Criteria:

  • antiviral therapy for chronic hepatitis B within the previous 6 months
  • hepatitis A, C, D or HIV infection
  • treatment with systemic acyclovir or famciclovir within the previous 6 months
  • decompensated liver disease (Childs B-C)
  • history or evidence of a medical condition associated with chronic liver disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179594

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: NCT01179594     History of Changes
Other Study ID Numbers: MV22597, 2009-017602-36
Study First Received: August 10, 2010
Last Updated: August 26, 2014
Health Authority: Korea: President of Samsung Medical Center

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 August 28, 2014