Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen (PADD-ON)

Johannes Gutenberg University (JGU)

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: Pegylated interferon alfa-2a plus nucleos(t)ide(s)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01524679

ML 27787

Details and patient eligibility

About

A prospective, randomised, open-label phase IIb clinical trial assessing the effect of pegylated interferon alfa-2a(Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B

The primary objective of the trial is to investigate whether the add-on of pegylated interferon alfa-2a to a continued treatment with nucleos(t)ide analogues increases the percentage of patients who have significant decrease (≥ 1log10) of HBs antigen after 48 weeks.

170 Patients with chronic hepatitis B, HBe antigen negative, already being treated with an oral antiviral regimen and having a nondetectable viral load for at least 12 months are included.

Enrollment: 170 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis B, HBe antigen negative
• treatment with a stable oral antiviral treatment (not containing telbivudine) and a fully suppressed viral load for at least 12 months (below limit of detection in conventional HBV-PCR assays, i.e. <116 IU / ml).
• 18-70 ys
• willingness and ability to give informed consent and to follow study procedures
• willingness to use adequate contraception

Exclusion criteria

• contraindications against treatment with pegylated interferon, e.g. depression, uncontrolled epilepsy, autoimmune diseases, pregnancy, leukocytopenia or thrombocytopenia at screening, etc.
• active alcohol or drug abuse
• preexisting polyneuropathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Treatment group

Experimental group

Description:

pegylated interferon alfa-2a (Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B

Treatment:

Drug: Pegylated interferon alfa-2a plus nucleos(t)ide(s)

Control group

No Intervention group

Description:

ongoing nucleos(t)ide based treatment alone