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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
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01706575
First received: October 10, 2012
Last updated: December 29, 2016
Last verified: December 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Hepatitis B, Chronic | Drug: Pegylated Interferon (Peginterferon) Alfa-2a Drug: Nucleos(t)ide Analogues (NA) | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase IIb, Open Label, Single Arm, Multicenter Study to Evaluate the Effect of 48-weeks PEG-Interferon Alfa-2a (PEG-IFN) Administration on Serum HBsAg in Chronic Hepatitis B, HBeAg-Negative, Genotype D Patients on Treatment With Nucleos(t)Ide Analogues (NAs), Showing Stable HBV DNA Suppression |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48) [ Time Frame: 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) [ Time Frame: Baseline and 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.
Secondary Outcome Measures:
- Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96 [ Time Frame: Baseline, Week 24, 72 and 96 ]Change is calculated by HBsAg titer at baseline - HBsAg titer at week of assessments.
- Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48 [ Time Frame: Baseline, Week 48 ]
- Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96 [ Time Frame: Week 12 up to Week 96 ]HBsAg loss is defined as HBsAg less than or equal to (</=) 0.05 IU/ml.
- Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes [ Time Frame: Baseline and Week 48 ]
- Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels [ Time Frame: Baseline and Week 48 ]
- Safety: Percentage of Participants With Adverse Events (AE) [ Time Frame: Baseline up to Week 48 ]An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
| Enrollment: | 76 |
| Study Start Date: | January 2013 |
| Study Completion Date: | November 2014 |
| Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: Pegylated Interferon (Peginterferon) Alfa-2a
Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks.
Other Name: Pegasys
Drug: Nucleos(t)ide Analogues (NA)
Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706575
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706575
Locations
| Italy | |
| Nuovo Policlinico; Dipartimento di Malattie Infettive | |
| Napoli, Campania, Italy, 80131 | |
| Napoli, Campania, Italy, 80131 | |
| UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In | |
| Bologna, Emilia-Romagna, Italy, 40138 | |
| Bologna, Emilia-Romagna, Italy, 40138 | |
| A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Medica | |
| Udine, Friuli-Venezia Giulia, Italy, 33100 | |
| Udine, Friuli-Venezia Giulia, Italy, 33100 | |
| Roma, Lazio, Italy, 00133 | |
| Policlinico Umberto I Di Roma | |
| Roma, Lazio, Italy, 00161 | |
| Roma, Lazio, Italy, 00161 | |
| D.I,M.I.; Cattedra Di Gastroenterologia | |
| Genova, Liguria, Italy, 16132 | |
| Genova, Liguria, Italy, 16132 | |
| Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia | |
| Milano, Lombardia, Italy, 20122 | |
| Milano, Lombardia, Italy, 20122 | |
| A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Gastroenterologia | |
| Torino, Piemonte, Italy, 10126 | |
| Torino, Piemonte, Italy, 10126 | |
| A.O. Universitaria Ospedali Riuniti Di Foggia; Malattie Infettive | |
| Foggia, Puglia, Italy, 71100 | |
| Foggia, Puglia, Italy, 71100 | |
| A.O. Universitaria Policlinico Monserrato Di Cagliari; Gastroenterologia | |
| Cagliari, Sardegna, Italy, 09042 | |
| Uni Di Cagliari; Dept. Di Scienze Mediche | |
| Cagliari, Sardegna, Italy, 09042 | |
| Cagliari, Sardegna, Italy, 09042 | |
| Az. Osp. Uni. Ria Policlinico G. Martino; Dept. Di Med. Interna E Terapia Medica - Ii Clinica Medica | |
| Messina, Sicilia, Italy, 98124 | |
| Messina, Sicilia, Italy, 98124 | |
| Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia | |
| Palermo, Sicilia, Italy, 90127 | |
| Palermo, Sicilia, Italy, 90127 | |
| Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia | |
| Pisa, Toscana, Italy, 56124 | |
| Pisa, Toscana, Italy, 56124 | |
| Padova, Veneto, Italy, 35128 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01706575 History of Changes |
| Other Study ID Numbers: |
ML28262 2012-000080-25 ( EudraCT Number ) |
| Study First Received: | October 10, 2012 |
| Results First Received: | June 24, 2016 |
| Last Updated: | December 29, 2016 |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis B Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Interferons Peginterferon alfa-2a Interferon-alpha Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 26, 2017