Treatment with association of two drugs (Viread and Pegasys) in patients with hepatitis B.

Sequential treatment with nucleotide analogue and peg-interferon in patients with HBV-related chronic hepatitis. - TRASANPIEC-HBV

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000453-37-IT

Enrollment

Registered

2014-09-03

Start date

2014-12-16

Completion date

Unknown

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B virus (HBV)

Interventions

Trade Name: Viread Product Name: Viread Pharmaceutical Form: Tablet Trade Name: Pegasys Product Name: Pegasys Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with chronic hepatitis HBsAg positive, HBeAg negative HBV-DNA> 20,000 IU / mL in two successive determinations or chronic hepatitis HBsAg positive, HBeAg positive with HBV DNA> 20,000 IU / mL in two successive determinations; - for which the practitioner indicates a treatment with peg-interferon alfa-2a; - with transaminases > 2 times the normal range in two successive determinations; - anti-HDV, anti-HCV and anti-HIV negative; - of which there is liver biopsy performed within 24 months prior to the start of therapy or Fibroscan performed within 6 months, proving HBV-related chronic hepatitis; - observing absolute abstention from alcohol; - available to participate in the study (informed consensus). 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 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Concomitant conditions that, in the opinion of the investigator, could compromise the patient's participation in the study or the results of the study, causing interference on the assessments provided by this protocol; - patients that are pregnant or breastfeeding; - people who are unable to understand and decide; - refusal to participation/withdrawal of consensus; - Hb <10 g/dl; - neutrophil count <1,500 cells/ml; - platelets <90,000 cells/ml; - treatment with antiviral therapy during the 12 months preceding the visit of enrollment in the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the effectiveness resulting from the addition of a treatment with Tenofovir before the start of therapy with peg-IFN-2a compared to treatment with peg-IFN-2a on the biochemical, virological and serological response in patients with chronic hepatitis HBeAg negative/positive .;Secondary Objective: Not applicable;Primary end point(s): Rate of sustained virological response (HBV DNA levels <2000UI/mL);Timepoint(s) of evaluation of this end point: 6 months from the end of treatment with peg-interferon alfa-2a	—

Measure

Time frame

Main Objective: Evaluate the effectiveness resulting from the addition of a treatment with Tenofovir before the start of therapy with peg-IFN-2a compared to treatment with peg-IFN-2a on the biochemical, virological and serological response in patients with chronic hepatitis HBeAg negative/positive .;Secondary Objective: Not applicable;Primary end point(s): Rate of sustained virological response (HBV DNA levels <2000UI/mL);Timepoint(s) of evaluation of this end point: 6 months from the end of treatment with peg-interferon alfa-2a

—

Secondary

Measure	Time frame
Secondary end point(s): Rate of biochemical response (normalization of ALT: <40 U / L);Timepoint(s) of evaluation of this end point: 6-12 months from the end of treatment with peg-interferon alfa-2a	—

Countries

Italy

Contacts

Public ContactU.O.C. Gastroenterologia

Azienda Ospedaliera di Padova

epatitivirali.aopd@sanita.padova.it+390498212890

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026