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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000080-25 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Interferon (Peginterferon) Alfa-2a | Drug | Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96 | Change is calculated by HBsAg titer at baseline - HBsAg titer at week of assessments. | Baseline, Week 24, 72 and 96 |
| Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O. Universitaria Ospedali Riuniti Di Foggia; Malattie Infettive | Foggia | Apulia | 71100 | Italy | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30187599 | Derived | 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. |
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A total of 76 participants started the study and were included in lead-in period. Out of 76 participants, 70 received study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Nucleos(t)ide Analogues (NA) | Drug | Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir. |
|
| Baseline, Week 48 |
| Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96 | HBsAg loss is defined as HBsAg less than or equal to (\ | 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 |
| Safety: Percentage of Participants With Adverse Events (AE) | 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. | Baseline up to Week 48 |
| Foggia |
| Apulia |
| 71100 |
| Italy |
| Nuovo Policlinico; Dipartimento di Malattie Infettive | Naples | Campania | 80131 | Italy |
| Naples | Campania | 80131 | Italy |
| UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In | Bologna | Emilia-Romagna | 40138 | Italy |
| Bologna | Emilia-Romagna | 40138 | Italy |
| A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Medica | Udine | Friuli Venezia Giulia | 33100 | Italy |
| Udine | Friuli Venezia Giulia | 33100 | Italy |
| Rome | Lazio | 00133 | Italy |
| Policlinico Umberto I Di Roma | Rome | Lazio | 00161 | Italy |
| Rome | Lazio | 00161 | Italy |
| D.I,M.I.; Cattedra Di Gastroenterologia | Genoa | Liguria | 16132 | Italy |
| Genoa | Liguria | 16132 | Italy |
| Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia | Milan | Lombardy | 20122 | Italy |
| Milan | Lombardy | 20122 | Italy |
| A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Gastroenterologia | Turin | Piedmont | 10126 | Italy |
| Turin | Piedmont | 10126 | Italy |
| A.O. Universitaria Policlinico Monserrato Di Cagliari; Gastroenterologia | Cagliari | Sardinia | 09042 | Italy |
| Uni Di Cagliari; Dept. Di Scienze Mediche | Cagliari | Sardinia | 09042 | Italy |
| Cagliari | Sardinia | 09042 | Italy |
| Az. Osp. Uni. Ria Policlinico G. Martino; Dept. Di Med. Interna E Terapia Medica - Ii Clinica Medica | Messina | Sicily | 98124 | Italy |
| Messina | Sicily | 98124 | Italy |
| Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia | Palermo | Sicily | 90127 | Italy |
| Palermo | Sicily | 90127 | Italy |
| Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia | Pisa | Tuscany | 56124 | Italy |
| Pisa | Tuscany | 56124 | Italy |
| Padova | Veneto | 35128 | Italy |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Lead-in participants included all participants enrolled in lead-in period.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48) | Per-Protocol Population (PP) included all participants without severe protocol violations, including major inclusion or exclusion criteria violations. | Posted | Mean | Standard Deviation | percent change | Baseline up to Week 48 |
|
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| ||||||||||||||||||||||||||
| Primary | 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. | PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations and who were undergoing the Week 48 visit. | Posted | Number | percentage of participants | Baseline and Week 48 |
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| Secondary | Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96 | Change is calculated by HBsAg titer at baseline - HBsAg titer at week of assessments. | PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations. Here, number of participants analyzed signifies those participants who were evaluable for the outcome measure and n signifies the number of participants who were evaluated at specified time points. | Posted | Mean | Standard Deviation | international units per millilitre | Baseline, Week 24, 72 and 96 |
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| Secondary | Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48 | PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations and who were undergoing the Week 48 visit. | Posted | Number | percentage of participants | Baseline, Week 48 |
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| Secondary | Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96 | HBsAg loss is defined as HBsAg less than or equal to (\ | PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations. | Posted | Number | participants | Week 12 up to Week 96 |
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| Secondary | Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes | Data were not collected, and the outcome measure was not analyzed. | Posted | Baseline and Week 48 |
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| Secondary | Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels | Data were not collected, and the outcome measure was not analyzed. | Posted | Baseline and Week 48 |
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| Secondary | Safety: Percentage of Participants With Adverse Events (AE) | 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. | Safety population included all participants who received least one dose of the study drug and had at least one post-dose safety assessment. | Posted | Number | percentage of participants | Baseline up to Week 48 |
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Baseline up to Week 48
Safety Population: Safety population included all participants who received least one dose of the study drug and had at least one post-dose safety assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 5 | 69 | 56 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Papillary thyroid cancer | Endocrine disorders | MedDRA (17.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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