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

NCT01706575 | Completed Phase 2 Results

• 2 other identifiers: ML282622012-000080-25
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 27

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

Outcome Measures

Primary Outcomes (2)

• Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48)

  Baseline up to Week 48

• Efficacy: Percentage of Participants With Serum Hepatitis B Surface Antigen (HBsAg) Decrease >/= 50% From Baseline at End of the Combination Treatment (Week 48)

  Participants who stopped pegylated interferon (PEG-IFN) treatment during the add-on phase due to serum HBsAg loss and HBsAg seroconversion were considered as responders.

  Baseline and Week 48

Secondary Outcomes (6)

• Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96

  Baseline, Week 24, 72 and 96

• Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48

  Baseline, Week 48

• Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96

  Week 12 up to Week 96

• Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes

  Baseline and Week 48

• Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels

  Baseline and Week 48

Study Arms (1)

Pegylated Interferon (Peginterferon) Alfa-2a

EXPERIMENTAL

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.

Drug: Pegylated Interferon (Peginterferon) Alfa-2a; Drug: Nucleos(t)ide Analogues (NA)

Interventions

Pegylated Interferon (Peginterferon) Alfa-2a DRUG

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

Also known as: Pegasys

Pegylated Interferon (Peginterferon) Alfa-2a

Nucleos(t)ide Analogues (NA) DRUG

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

Pegylated Interferon (Peginterferon) Alfa-2a

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (27)

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

Foggia, Apulia, 71100, Italy

Location

Unknown Facility

Foggia, Apulia, 71100, Italy

Location

Nuovo Policlinico; Dipartimento di Malattie Infettive

Napoli, Campania, 80131, Italy

Location

Unknown Facility

Napoli, Campania, 80131, Italy

Location

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

Bologna, Emilia-Romagna, 40138, Italy

Location

Unknown Facility

Bologna, Emilia-Romagna, 40138, Italy

Location

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

Udine, Friuli Venezia Giulia, 33100, Italy

Location

Unknown Facility

Udine, Friuli Venezia Giulia, 33100, Italy

Location

Unknown Facility

Rome, Lazio, 00133, Italy

Location

Policlinico Umberto I Di Roma

Rome, Lazio, 00161, Italy

Location

Unknown Facility

Rome, Lazio, 00161, Italy

Location

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

Genoa, Liguria, 16132, Italy

Location

Unknown Facility

Genoa, Liguria, 16132, Italy

Location

Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

Milan, Lombardy, 20122, Italy

Location

Unknown Facility

Milan, Lombardy, 20122, Italy

Location

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

Turin, Piedmont, 10126, Italy

Location

Unknown Facility

Turin, Piedmont, 10126, Italy

Location

A.O. Universitaria Policlinico Monserrato Di Cagliari; Gastroenterologia

Cagliari, Sardinia, 09042, Italy

Location

Uni Di Cagliari; Dept. Di Scienze Mediche

Cagliari, Sardinia, 09042, Italy

Location

Unknown Facility

Cagliari, Sardinia, 09042, Italy

Location

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

Messina, Sicily, 98124, Italy

Location

Unknown Facility

Messina, Sicily, 98124, Italy

Location

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

Palermo, Sicily, 90127, Italy

Location

Unknown Facility

Palermo, Sicily, 90127, Italy

Location

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

Pisa, Tuscany, 56124, Italy

Location

Unknown Facility

Pisa, Tuscany, 56124, Italy

Location

Unknown Facility

Padua, Veneto, 35128, Italy

Location

Related Publications (1)

• 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.

  PMID: 30187599 DERIVED

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: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 15, 2012
• Study Start: January 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2014
• Last Updated: February 20, 2017
• Results First Posted: August 5, 2016

Record last verified: 2016-12

Locations

IT (27)