A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Patients With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable HBV DNA Suppression
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01706575
First received: October 10, 2012
Last updated: February 5, 2015
Last verified: February 2015
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 patients with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, patients 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 patients will continue their NA treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B, Chronic |
Drug: nucleos(t)ide analogues Drug: peginterferon alfa-2a [Pegasys] |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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:
- Proportion of patients with serum HBsAg decrease >/= 50% from baseline to the end of the combination treatment Pegasys plus NA (Study Week 48) [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients with HBsAg decrease >/=1 log10 IU/ml from baseline to Week 48 [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
- Change in HBsAg levels [ Time Frame: from baseline to Week 96 ] [ Designated as safety issue: No ]
- Proportion of patients with HBsAg </= 0.05 UI/ml at Week 48 [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
- Proportion of patients with HBsAg </= 0.05 UI/ml at Week 72 [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
- Proportion of patients with HBsAg </= 0.05 UI/ml at Week 96 [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
- HBsAg levels according to IL28B genotypes [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
- HBsAg levels according to IP-10 serum levels [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
| Enrollment: | 70 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pegasys |
Drug: nucleos(t)ide analogues
Adenovir, entecavir, lamivudine or tenofovir
Drug: peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously weekly, 48 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, 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 HAV, HCV, HDV, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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 | |
| Napoli, Campania, Italy, 80131 | |
| Bologna, Emilia-Romagna, Italy, 40138 | |
| Udine, Friuli-Venezia Giulia, Italy, 33100 | |
| Roma, Lazio, Italy, 00161 | |
| Roma, Lazio, Italy, 00133 | |
| 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
No publications provided
| 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 |
| Last Updated: | February 5, 2015 |
| Health Authority: | Italy: Agenzia Italiana del Farmaco (AIFA) |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis B, Chronic DNA Virus Infections Digestive System Diseases Enterovirus Infections Hepadnaviridae Infections Hepatitis, Chronic Hepatitis, Viral, Human |
Liver Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases Peginterferon alfa-2a Anti-Infective Agents Antiviral Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015