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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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
Health authority
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Status Withdrawn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

Study Design


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
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