A Phase 4 interventional study of entecavir and entecavir in Hepatitis B, Chronic, sponsored by Hoffmann-La Roche. Completed at 7 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-03-25.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
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.
954 studies on the registry are indexed under Hepatitis B, Chronic; 147 are open to participants now.
This study's enrollment of 200 is above the median of 100 across 692 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.
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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.
Drug: entecavir · Drug: peginterferon alfa-2a [Pegasys]
Participants received entecavir 0.5 mg orally once daily for 48 weeks.
Drug: entecavir
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).
Time frame: At Week 48
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.
Time frame: At Week 48
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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 48
A total of 332 participants were enrolled in this study conducted from 28 April 2009 to 23 December 2011 at seven centers in China.
| Milestone | Peginterferon Alfa-2a + Entecavir | Entecavir |
|---|---|---|
| Started | 97 | 100 |
| Completed | 82 | 93 |
| Not completed | 15 | 7 |
| Withdrew: Hbeab positive at baseline | 3 | 2 |
| Withdrew: Lost to follow-up | 2 | 3 |
| Withdrew: Adverse event | 8 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Others | 1 | 1 |
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).
| Percentage of participants | Peginterferon Alfa-2a + Entecavir | Entecavir |
|---|---|---|
| Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48 | 14.89 (8.39 to 23.72) | 6.12 (2.28 to 12.85) |
Loss of Hepatitis B Envelope Antigen (HBeAg) is defined as the absence of HBeAg.
| Percentage of participants | Peginterferon Alfa-2a + Entecavir | Entecavir |
|---|---|---|
| Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48 | 62.77 (52.18 to 72.52) | 60.20 (49.82 to 69.96) |
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.
| Percentage of participants | Peginterferon Alfa-2a + Entecavir | Entecavir |
|---|---|---|
| Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48 | 62.77 (52.18 to 72.52) | 91.84 (84.55 to 96.41) |
Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.
| Percentage of participants | Peginterferon Alfa-2a + Entecavir | Entecavir |
|---|---|---|
| Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48 | 8.51 (3.75 to 16.08) | 0 (0 to 3.69) |
Hepatitis B Surface Antigen (HBsAg) seroconversion was defined as loss of HBsAg and presence of anti-HBs .(antibody to Hepatitis B surface antigen)
| Percentage of participants | Peginterferon Alfa-2a + Entecavir | Entecavir |
|---|---|---|
| Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48 | 4.26 (1.17 to 10.54) | 0 (0 to 3.69) |
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.
| Percentage of participants | Peginterferon Alfa-2a + Entecavir | Entecavir |
|---|---|---|
| Percentage of Participants With Normalized Alanine Aminotransferase at Week 48 | 51.06 (40.54 to 61.52) | 85.71 (77.19 to 91.96) |
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.
| PEIU/ml) | Peginterferon Alfa-2a + Entecavir | Entecavir |
|---|---|---|
| At Week 0; n= 93, 95 | 8.33 ± 18.76 | 5.66 ± 10.33 |
| At Week 8; n= 93, 97 | 4.76 ± 11.63 | 5.85 ± 12.55 |
| At Week 12; n= 94, 97 | 3.83 ± 10.57 | 5.00 ± 10.56 |
| At Week 24; n= 91, 97 | 2.28 ± 5.81 | 4.76 ± 11.40 |
| At Week 36; n= 88, 94 | 3.58 ± 16.66 | 4.52 ± 10.10 |
| At Week 48; n= 85, 92 | 13.23 ± 93.02 | 4.07 ± 9.15 |
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.
| IU/ml | Peginterferon Alfa-2a + Entecavir | Entecavir |
|---|---|---|
| At Week 0; n= 93, 95 | 3737.84 ± 4617.19 | 3241.06 ± 3592.60 |
| At Week 8; n= 93, 97 | 3603.56 ± 4553.66 | 3050.79 ± 3313.12 |
| At Week 12; n= 94, 97 | 3041.86 ± 3782.70 | 3037.82 ± 3498.73 |
| At Week 24; n= 91, 97 | 2280.60 ± 3429.61 | 2895.25 ± 3336.91 |
| At Week 36; n= 88, 94 | 2097.89 ± 3458.84 | 2699.18 ± 2964.25 |
| At Week 48; n= 85, 92 | 1886.02 ± 2627.33 | 2672.71 ± 3065.97 |
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.
| Participants | Peginterferon Alfa-2a + Entecavir | Entecavir |
|---|---|---|
| Non serious AE | 65 | 5 |
| Serious AE | 6 | 0 |
| AE | 67 | 5 |
Participants with clinically significant laboratory abnormalities which were captured as an AE (at the \>=5% threshold) were presented.
| Participants | Peginterferon Alfa-2a + Entecavir | Entecavir |
|---|---|---|
| Haemoglobin decreased | 6 | 0 |
| Aspartate aminotransferase increased | 8 | 0 |
| Alanine aminotransferase increased | 9 | 0 |
| Platelet count decreased | 42 | 0 |
| Neutrophil count decreased | 53 | 0 |
| White blood cell count decreased | 59 | 0 |
Collected over Up to Week 48. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Peginterferon Alfa-2a + Entecavir | — | 6/97 (6.2%) | 65/97 (67%) |
| Entecavir | — | 0/100 (0%) | 5/100 (5%) |
| Event | Peginterferon Alfa-2a + Entecavir | Entecavir |
|---|---|---|
| HyperthyroidismEndocrine disorders | 2/97 | 0/100 |
| HypothyroidismEndocrine disorders | 1/97 | 0/100 |
| Viral myocarditisInfections and infestations | 1/97 | 0/100 |
| Lung infectionInfections and infestations | 1/97 | 0/100 |
| Myocardial ischaemiaCardiac disorders | 1/97 | 0/100 |
| HaemorrhoidsGastrointestinal disorders | 1/97 | 0/100 |
| Event | Peginterferon Alfa-2a + Entecavir | Entecavir |
|---|---|---|
| White blood cell count decreasedInvestigations | 59/97 | 0/100 |
| Neutrophil count decreasedInvestigations | 53/97 | 0/100 |
| Platelet count decreasedInvestigations | 42/97 | 0/100 |
| PyrexiaGeneral disorders | 15/97 | 0/100 |
| Alanine aminotransferase increasedInvestigations | 9/97 | 0/100 |
| Aspartate aminotransferase increasedInvestigations | 8/97 | 0/100 |
| Haemoglobin decreasedInvestigations | 6/97 | 0/100 |
| AlopeciaSkin and subcutaneous tissue disorders | 5/97 | 0/100 |
| ErythropeniaBlood and lymphatic system disorders | 5/97 | 0/100 |
| HyperlipidaemiaMetabolism and nutrition disorders | 4/97 | 1/100 |
Full analysis set (FAS) included all randomized subjects who had baseline evaluations and at least one efficacy evaluation.
| Age, Continuous(years) | Peginterferon Alfa-2a + Entecavir | Entecavir | Total |
|---|---|---|---|
| Mean | 33.38 ± 8.25 | 33.28 ± 8.95 | 33.3 ± 8.6 |
| Sex: Female, Male(Participants) | Peginterferon Alfa-2a + Entecavir | Entecavir | Total |
|---|---|---|---|
| Female | 19 | 13 | 32 |
| Male | 75 | 85 | 160 |
The record gives a start of Apr 2009, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2016, 4 years 2 months after primary completion.
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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Peginterferon alfa-2a