Peg-interferon ADDed to an Ongoing Nucleos(t)ide based treatment in patients with chronic hepatitis B to induce decrease of HBs-Antige

Phase 1

• Conditions: Patients with chronic HBeAg-negative hepatitis B 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).; MedDRA version: 20.0Level: LLTClassification code 10019738Term: Hepatitis B positiveSystem Organ Class: 100000109834; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-002812-10-DE
• Lead Sponsor: niversity Medical Center of the Johannes Gutenberg University Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-21
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 yrs
• Willingness and ability to give informed consent and to follow study procedures
• willingness to use adequate contraception

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 153
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

• HBe antigen positive Hepatitis B
• Co-infection with HCV, HDV or HIV – as based on positive serology or PCR
• Ongoing antiviral treatment with Telbivudine
• Contraindications against treatment with pegylated interferon, e.g. severe depression, epilepsy, autoimmune diseases, pregnancy, leukocytopenia or thrombocytopenia at screening, etc.
• Preexisting polyneuropathy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified