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SOFIA-LTT Study: A Study of Intermittent Long Term Treatment With PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Negative Chronic Hepatitis B (CHB).

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Roche

Status and phase

Completed
Phase 2

Conditions

Hepatitis B, Chronic

Treatments

Drug: PEGASYS [peginterferon alfa-2a]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00442572
ML20020

Details and patient eligibility

About

This 2 arm study will evaluate the efficacy and safety of intermittent treatment with PEGASYS in HBeAg negative patients with chronic hepatitis B who have demonstrated virological and biochemical response after treatment with interferon alfa. After 48 weeks therapy with interferon alfa, and 24 weeks treatment-free follow-up, eligible patients will be randomized into the PEGASYS or the observational group. Those in the PEGASYS group will receive 4 therapeutic cycles of long term intermittent treatment with PEGASYS (135 micrograms sc weekly for 12 weeks, followed by a treatment-free period of 12 weeks) and those in the observational arm will receive no specific antiviral treatment. The anticipated time on study treatment is 1-2 years, and the target sample size is 100 individuals.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adult patients, >=18 years of age;
  • liver disease consistent with CHB;
  • evidence of chronic HBeAg-negative CHB prior to initial course of interferon alfa;
  • patients who have responded to previous 48 weeks treatment with interferon alfa.

Exclusion criteria

  • coinfection with HCV, HDV or HIV;
  • decompensated liver disease, hepatocellular cancer, or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
  • any other systemic antiviral, antineoplastic or immunomodulatory treatment <=6 months prior to first dose of randomized treatment.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

21 participants in 2 patient groups

PEGASYS
Experimental group
Description:
Participants received 4 treatment cycles of continuous intermittent treatment with PEGASYS® (Peginterferon alfa-2a) . Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment.
Treatment:
Drug: PEGASYS [peginterferon alfa-2a]
No Intervention
No Intervention group
Description:
Participants were on non- specific anti-viral treatment.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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