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).

NCT00442572 | Completed Phase 2 Results

• 1 other identifier: ML20020
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Stable Virological Response

  Stable virological response is serum Hepatitis B virus deoxyribonucleic acid (HBV DNA) \<20 000 copies/ml during the treatment (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).

  Up to Week 108

Secondary Outcomes (16)

• Percentage of Participants With Stable Virological and Biochemical Response

  Up to Week 108

• Percentage of Participants With Loss of Hepatitis B Surface Antigen

  Up to Week 108

• Percentage of Participants With HBsAg Seroconversion

  Up to Week 108

• Percentage of Participants With HBV DNA Levels Under the Lower Limit (Serum HBV DNA Level < 300 Copies/ml) For a Significant Quantity

  Up to Week 108

• Fibrosis-4 and Aspartate Aminotransferase to Platelet Ratio Index Scores For Change in Liver Fibrosis

  Up to Week 108

Study Arms (2)

PEGASYS

EXPERIMENTAL

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.

Drug: PEGASYS [peginterferon alfa-2a]

No Intervention

NO INTERVENTION

Participants were on non- specific anti-viral treatment.

Interventions

PEGASYS [peginterferon alfa-2a] DRUG

There were 4 treatment cycles of continuous intermittent treatment with 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.

PEGASYS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Mhat St. Ivan Rilski; Clinic of Gastroenterology

Sofia, 1612, Bulgaria

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2007
• First Posted: March 2, 2007
• Study Start: July 3, 2006
• Primary Completion: April 23, 2012
• Study Completion: April 23, 2012
• Last Updated: April 24, 2025
• Results First Posted: April 11, 2016

Record last verified: 2025-04

Locations

BU (1)