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: June 24, 2016
Last verified: June 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: | Endpoint Classification: Safety/Efficacy Study 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
- Efficacy: Percentage of Participants With Serum HBsAg Loss at Week 48, 72 and 96 [ Time Frame: Week 48, 72 and 96 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
- Safety: Number of Participants With Adverse Events (AE) [ Time Frame: Baseline up to Week 48 ] [ Designated as safety issue: No ]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) |
| Genders Eligible for Study: | Both |
| 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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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 | |
| Napoli, Campania, Italy, 80131 | |
| Bologna, Emilia-Romagna, Italy, 40138 | |
| Udine, Friuli-Venezia Giulia, Italy, 33100 | |
| Roma, Lazio, Italy, 00133 | |
| Roma, Lazio, Italy, 00161 | |
| Genova, Liguria, Italy, 16132 | |
| Milano, Lombardia, Italy, 20122 | |
| Torino, Piemonte, Italy, 10126 | |
| Foggia, Puglia, Italy, 71100 | |
| Cagliari, Sardegna, Italy, 09042 | |
| Messina, Sicilia, Italy, 98124 | |
| Palermo, Sicilia, Italy, 90127 | |
| 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 |
| Study First Received: | October 10, 2012 |
| Results First Received: | June 24, 2016 |
| Last Updated: | June 24, 2016 |
| Health Authority: | Italy: Agenzia Italiana del Farmaco (AIFA) |
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 September 29, 2016