A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression

NCT ID: NCT01706575

Last Updated: 2017-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-11-30

Brief Summary

This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, participants with a HBsAg decline <0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will be a further 48 weeks, during which the participants will continue their NA treatment.

Conditions

Hepatitis B, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pegylated Interferon (Peginterferon) Alfa-2a

Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than \<0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.

Group Type: EXPERIMENTAL

Pegylated Interferon (Peginterferon) Alfa-2a

Intervention Type: DRUG

Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks.

Nucleos(t)ide Analogues (NA)

Intervention Type: DRUG

Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.

Interventions

Pegylated Interferon (Peginterferon) Alfa-2a

Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks.

Intervention Type: DRUG

Nucleos(t)ide Analogues (NA)

Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.

Intervention Type: DRUG

Other Intervention Names

Pegasys

Eligibility Criteria

Inclusion Criteria

• Adult participants, 18 - 65 years of age
• Chronic hepatitis B
• Negative for HBeAg
• On monotherapy with any nucleos(t)ide analogue (NA) but telbivudine at enrolment, and HBV DNA persistently below 20 IU/ml for at least 12 months
• HBsAg >100 IU/ml at the beginning of the Lead-in phase, confirmed before addition of Pegasys
• Showing a steady HBsAg kinetic (HBsAg decrease <0.5 log10 IU/ml from Week -12 to start of the Add-on phase)
• Negative pregnancy test for women of childbearing potential
• Women of childbearing potential and fertile males with female partners of childbearing potential must be using reliable contraception during and for 3 months after the Add-on phase

Exclusion Criteria

• Coinfection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus (HDV), Human Immunodeficiency virus (HIV)
• Evidence of decompensated liver disease (Child-Pugh >/=6)
• History or other evidence of a medical condition associated with chronic liver disease (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
• Known hypersensitivity to peginterferon alfa-2a
• Pregnant of breastfeeding women
• Evidence of alcohol and/or drug abuse
• History of severe psychiatric disease, especially depression
• History of immunologically mediated disease
• History or evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
• History or evidence of severe pulmonary disease associated with functional limitations
• History of severe cardiac disease
• History of severe seizure disorder or current anticonvulsant use
• Evidence of an active or suspected cancer or a history of malignancy (other than basocellular carcinoma or in situ cervical carcinoma) within 5 years prior to study entry
• History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory (including systemic corticosteroids) treatment </= 6 months prior to the first dose or the expectation that such a treatment will be needed at any time during the study
• History or other evidence of severe retinopathy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

A.O. Universitaria Ospedali Riuniti Di Foggia; Malattie Infettive

Foggia, Apulia, Italy

Foggia, Apulia, Italy

Nuovo Policlinico; Dipartimento di Malattie Infettive

Napoli, Campania, Italy

Napoli, Campania, Italy

UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In

Bologna, Emilia-Romagna, Italy

Bologna, Emilia-Romagna, Italy

A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Medica

Udine, Friuli Venezia Giulia, Italy

Udine, Friuli Venezia Giulia, Italy

Rome, Lazio, Italy

Policlinico Umberto I Di Roma

Rome, Lazio, Italy

Rome, Lazio, Italy

D.I,M.I.; Cattedra Di Gastroenterologia

Genoa, Liguria, Italy

Genoa, Liguria, Italy

Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

Milan, Lombardy, Italy

Milan, Lombardy, Italy

A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Gastroenterologia

Turin, Piedmont, Italy

Turin, Piedmont, Italy

A.O. Universitaria Policlinico Monserrato Di Cagliari; Gastroenterologia

Cagliari, Sardinia, Italy

Uni Di Cagliari; Dept. Di Scienze Mediche

Cagliari, Sardinia, Italy

Cagliari, Sardinia, Italy

Az. Osp. Uni. Ria Policlinico G. Martino; Dept. Di Med. Interna E Terapia Medica - Ii Clinica Medica

Messina, Sicily, Italy

Messina, Sicily, Italy

Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia

Palermo, Sicily, Italy

Palermo, Sicily, Italy

Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia

Pisa, Tuscany, Italy

Pisa, Tuscany, Italy

Padua, Veneto, Italy

Countries

Italy

References

Lampertico P, Brunetto MR, Craxi A, Gaeta GB, Rizzetto M, Rozzi A, Colombo M; HERMES Study Group. Add-on peginterferon alfa-2a to nucleos(t)ide analogue therapy for Caucasian patients with hepatitis B 'e' antigen-negative chronic hepatitis B genotype D. J Viral Hepat. 2019 Jan;26(1):118-125. doi: 10.1111/jvh.12999. Epub 2018 Dec 11.

Reference Type: DERIVED

PMID: 30187599 (View on PubMed)

Other Identifiers

2012-000080-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML28262

Identifier Type: -

Identifier Source: org_study_id