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This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon alfa-2a + entecavir | Experimental | Participants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks. |
|
| Entecavir | Active Comparator | Participants received entecavir 0.5 mg orally once daily for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| entecavir | Drug | 0.5mg po daily for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48 | Hepatitis B envelope Antigen (HBeAg) seroconversion was defined as the absence of HBeAg and the presence of antibody to Hepatitis B envelope antigen (anti-HBe). | At Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48 | Loss of Hepatitis B Envelope Antigen (HBeAg) is defined as the absence of HBeAg. | At Week 48 |
| Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changsha | 410008 | China | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25814467 | Derived | Yan W, Wu D, Wang X, Chen T, Lai Q, Zheng Q, Jiang J, Hou J, Han M, Ning Q. Upregulation of NKG2C+ natural killer cells, TLR-2 expression on monocytes and downregulation of regulatory T-cells influence PEG-IFN treatment efficacy in entecavir-suppressed patients with CHB. Antivir Ther. 2015;20(6):591-602. doi: 10.3851/IMP2953. Epub 2015 Mar 27. | |
| 24915612 |
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Of 332 participants, 200 were randomized, out of which 97 participants were assigned to Peginterferon alfa-2a + entecavir and 100 were assigned to entecavir, and three participants did not take any study drug.
A total of 332 participants were enrolled in this study conducted from 28 April 2009 to 23 December 2011 at seven centers in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon Alfa-2a + Entecavir | Participants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks. |
| FG001 | Entecavir |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| entecavir |
| Drug |
0.5mg po daily for 48 weeks |
|
| peginterferon alfa-2a [Pegasys] | Drug | 180 micrograms sc/week for 48 weeks |
|
Blood was collected for Hepatitis B Virus - Deoxyribonucleic Acid (HBV -DNA) and was analysed at the central laboratories using the Roche approved polymerase chain reaction (PCR) methodology at Week 48. Percentage of participants with HBV-DNA < 1000 copies/mL was reported. |
| At Week 48 |
| Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48 | Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative. | At Week 48 |
| Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48 | Hepatitis B Surface Antigen (HBsAg) seroconversion was defined as loss of HBsAg and presence of anti-HBs .(antibody to Hepatitis B surface antigen) | At Week 48 |
| Percentage of Participants With Normalized Alanine Aminotransferase at Week 48 | Normalized Alanine Aminotransferase (ALT) is defined as having a baseline ALT value > upper limit of normal (ULN), and a decrease in ALT value to ≤ ULN at the given time point. | At Week 48 |
| Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time | Quantitative hepatitis B envelope antigen (HBeAg) results were analyzed in central lab. Values that were less than lower limit of quantification (LLOQ) had been replaced by LLOQ when analyzed, e.g. <1000 was replaced by 1000 and <0.2 was replaced by 0.2. Quantitative HBeAg value unit was calculated using 'Paul Ehrlich Institute units per millilitre' (PEIU/ml). Change in HBeAg was analysed at Weeks 0, 8, 12, 24, 36, and 48. | Up to Week 48 |
| Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time | Quantitative Hepatitis B Surface Antigen (HBsAg) results were analyzed in central lab. Values that were less than LLOQ had been replaced by LLOQ when analyzed, e.g. <1000 was replaced by 1000 and <0.2 was replaced by 0.2. Quantitative HBsAg calculated using 'International Units Per Millilitre' (IU/mL). Change in HBsAg was analysed at Weeks 0, 8, 12, 24, 36, and 48. | Up to Week 48 |
| Number of Participants With Incidence of Adverse Events and Serious Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. | Up to Week 48 |
| Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event | Participants with clinically significant laboratory abnormalities which were captured as an AE (at the >=5% threshold) were presented. | Up to Week 48 |
| Chengdu |
| 610041 |
| China |
| Fuzhou | 350005 | China |
| Guangzhou | 510515 | China |
| Hangzhou | 310003 | China |
| Wuhan | 430030 | China |
| Xi'an | 710038 | China |
| Ning Q, Han M, Sun Y, Jiang J, Tan D, Hou J, Tang H, Sheng J, Zhao M. Switching from entecavir to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: a randomised open-label trial (OSST trial). J Hepatol. 2014 Oct;61(4):777-84. doi: 10.1016/j.jhep.2014.05.044. Epub 2014 Jun 7. |
Participants received entecavir 0.5 mg orally once daily for 48 weeks. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Full analysis set (FAS) included all randomized subjects who had baseline evaluations and at least one efficacy evaluation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon Alfa-2a + Entecavir | Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks. |
| BG001 | Entecavir | Participants received entecavir 0.5 mg orally once daily for 48 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48 | Hepatitis B envelope Antigen (HBeAg) seroconversion was defined as the absence of HBeAg and the presence of antibody to Hepatitis B envelope antigen (anti-HBe). | Full analysis set included all patients who were randomized and received at least one dose of the study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 48 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48 | Loss of Hepatitis B Envelope Antigen (HBeAg) is defined as the absence of HBeAg. | Full analysis set included all patients who were randomized and received at least one dose of the study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 48 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48 | Blood was collected for Hepatitis B Virus - Deoxyribonucleic Acid (HBV -DNA) and was analysed at the central laboratories using the Roche approved polymerase chain reaction (PCR) methodology at Week 48. Percentage of participants with HBV-DNA < 1000 copies/mL was reported. | Full analysis set included all patients who were randomized and received at least one dose of the study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 48 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48 | Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative. | Full analysis set included all patients who were randomized and received at least one dose of the study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 48 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48 | Hepatitis B Surface Antigen (HBsAg) seroconversion was defined as loss of HBsAg and presence of anti-HBs .(antibody to Hepatitis B surface antigen) | Full analysis set included all patients who were randomized and received at least one dose of the study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 48 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Normalized Alanine Aminotransferase at Week 48 | Normalized Alanine Aminotransferase (ALT) is defined as having a baseline ALT value > upper limit of normal (ULN), and a decrease in ALT value to ≤ ULN at the given time point. | Full analysis set included all patients who were randomized and received at least one dose of the study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 48 |
|
| |||||||||||||||||||||||||||||
| Secondary | Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time | Quantitative hepatitis B envelope antigen (HBeAg) results were analyzed in central lab. Values that were less than lower limit of quantification (LLOQ) had been replaced by LLOQ when analyzed, e.g. <1000 was replaced by 1000 and <0.2 was replaced by 0.2. Quantitative HBeAg value unit was calculated using 'Paul Ehrlich Institute units per millilitre' (PEIU/ml). Change in HBeAg was analysed at Weeks 0, 8, 12, 24, 36, and 48. | Full analysis set included all patients who were randomized and received at least one dose of the study drug. Maximum participants available at particular time point were analysed. | Posted | Mean | Standard Deviation | PEIU/ml) | Up to Week 48 |
|
| |||||||||||||||||||||||||||||
| Secondary | Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time | Quantitative Hepatitis B Surface Antigen (HBsAg) results were analyzed in central lab. Values that were less than LLOQ had been replaced by LLOQ when analyzed, e.g. <1000 was replaced by 1000 and <0.2 was replaced by 0.2. Quantitative HBsAg calculated using 'International Units Per Millilitre' (IU/mL). Change in HBsAg was analysed at Weeks 0, 8, 12, 24, 36, and 48. | Full analysis set included all patients who were randomized and received at least one dose of the study drug. Maximum participants available at particular time point were analysed. | Posted | Mean | Standard Deviation | IU/ml | Up to Week 48 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Incidence of Adverse Events and Serious Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. | Safety set (SS) included all the participants who received at least 1 dose of study drug and who had at least undergone safety assessment once, regardless of whether the patients withdrew from the study or not. | Posted | Number | Participants | Up to Week 48 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event | Participants with clinically significant laboratory abnormalities which were captured as an AE (at the >=5% threshold) were presented. | Safety set (SS) included all the participants who received at least 1 dose of study drug and who had at least undergone safety assessment once, regardless of whether the patients withdrew from the study or not. | Posted | Number | Participants | Up to Week 48 |
|
|
Up to Week 48
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
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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 | Peginterferon Alfa-2a + Entecavir | Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks. | 6 | 97 | 65 | 97 | ||
| EG001 | Entecavir | Participants received entecavir 0.5 mg orally once daily for 48 weeks. | 0 | 100 | 5 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | 14.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 14.1 | Systematic Assessment |
| |
| Viral myocarditis | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | 14.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemoglobin decreased | Investigations | 14.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 14.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 14.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 14.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 14.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 14.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
| |
| Erythropenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
| |
| Red blood cells urine positive | Investigations | 14.1 | Systematic Assessment |
| |
| Ultrasound liver abnormal | Investigations | 14.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | 14.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | 14.1 | Systematic Assessment |
| |
| Protein urine present | Investigations | 14.1 | Systematic Assessment |
| |
| Thyroxine increased | Investigations | 14.1 | Systematic Assessment |
| |
| Tri-iodothyronine increased | Investigations | 14.1 | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | 14.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 14.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 14.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 14.1 | Systematic Assessment |
| |
| Chest pain | General disorders | 14.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 14.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | 14.1 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | 14.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | 14.1 | Systematic Assessment |
| |
| Marasmus | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 14.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
|
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 | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.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 |
|---|---|
| C413685 | entecavir |
| C100416 | peginterferon alfa-2a |
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| Male |
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| Units |
|---|
| Counts |
|---|
| Participants |
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