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

Hepatitis B, Chronic Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01179594
• Other study ID #: MV22597
• Secondary ID: 2009-017602-36
• Status: Withdrawn
• Phase: Phase 4
• First received: August 10, 2010
• Last updated: February 16, 2017
• Start date: September 18, 2010
• Est. completion date: November 2014

Study information

• Verified date: February 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a [Pegasys], with or without 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) during weeks 12-36, or Pegasys (180mcg subcutaneously weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during weeks 12-36. Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target sample size is <500 patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• entecavir
0.5 mg orally daily, 24 weeks (weeks 12-36)
• peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 48 weeks
• peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 96 weeks
• placebo
orally daily, 24 weeks (weeks 12-36)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml)		48 weeks after the end of treatment
Secondary	Correlation early HBsAg response - response end of treatment/follow-up		every 6 weeks up to week 48, every 12 weeks therafter