Clinical Trials List
Protocol NumberNV25361
NCT Number(ClinicalTrials.gov Identfier)NCT02263079
2014-12-01 - 2020-12-31
Phase III
Terminated2
ICD-10B18.9
Chronic viral hepatitis, unspecified
Phase IIIB, Randomized, Open-Label Study of Pegylated Interferon Alfa-2A in Combination with Lamivudine Compared with Untreated Control Patients in Children with HBEAG-Positive Chronic Hepatitis B in the Immune-Tolerant Phase
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Trial Applicant
-
Sponsor
Hoffmann-La Roche
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 吳嘉峰 Division of Pediatrics
- Huey-Ling Chen Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Chronic Hepatitis B
Objectives
EFFICACY OBJECTIVES
The primary efficacy objective for this study is as follows:
• To evaluate the efficacy of Pegasys® + lamivudine compared with an untreated
control in children with CHB, as measured by loss of HBsAg 24 weeks post-end of
treatment/end of untreated observation
The secondary efficacy objectives for this study are as follows:
• To evaluate efficacy of Pegasys® + lamivudine compared with an untreated control in
children with CHB, as measured by seroconversion to anti-HBs, seroconversion to
anti-HBe, loss of HBeAg, and HBV DNA levels, at 24 weeks post-end of
treatment/end of untreated observation
• To evaluate efficacy of Pegasys® + lamivudine in children with CHB, as measured by
seroconversion to anti-HBs, seroconversion to anti-HBe, loss of HBsAg, loss of
HBeAg, HBV DNA levels, and at 1, 2, 3, 4, and 5 years post-end of treatment
SAFETY OBJECTIVES
The safety objectives for this study are as follows:
• To evaluate the safety of the Pegasys® + lamivudine group compared with untreated
control group in children with CHB, by assessment of adverse events (including
neurological and psychiatric events), laboratory test results (including thyroid
function), vital signs and growth, up to 24 weeks post-end of treatment/end of
untreated observation
• To evaluate the longer-term safety of Pegasys® + lamivudine in children with CHB,
by assessment of adverse events, thyroid function and growth during a further
4.5−year long-term follow-up
Test Drug
Pegasys®/Lamivudine/ENTECAVIR
Active Ingredient
ENTECAVIR
Lamivudine
Peginterferon alfa-2a
Lamivudine
Peginterferon alfa-2a
Dosage Form
Tablet
oral solution
Tablet
Solution for injection
oral solution
Tablet
Solution for injection
Dosage
0.5
0.05
100
180
0.05
100
180
Endpoints
Primary Outcome Measures :
1. Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) at 24 Weeks Post-End of Treatment/End of Untreated Observation [ Time Frame: 24 weeks post-treatment/at the end of untreated observation (Week 80) ]
This endpoint is defined as loss of HBsAg at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80). The percentage of responders (response rate) and 95% CI (using the Clopper-Pearson method) for the response rate are presented for each group.
1. Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) at 24 Weeks Post-End of Treatment/End of Untreated Observation [ Time Frame: 24 weeks post-treatment/at the end of untreated observation (Week 80) ]
This endpoint is defined as loss of HBsAg at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80). The percentage of responders (response rate) and 95% CI (using the Clopper-Pearson method) for the response rate are presented for each group.
Inclution Criteria
Inclusion Criteria:
• Positive for HBsAg and HBeAg for more than 6 months prior to baseline
• Detectable HBV-DNA (>20,000 IU/mL) as measured by polymerization chain reaction (PCR) or hybridization on at least 2 occasions at least one month apart with the latest determination obtained less than or equal to ( • Compensated liver disease (Child-Pugh Class A clinical classification)
• Either Liver biopsy performed within 2 years prior to baseline showing no or minimal fibrosis (Liver Biopsy Scores and stable normal ALT levels (less than or equal to upper limit of normal [ULN]) during the 6 months leading up to baseline (including two separate occasions at least 1 month apart over the 6 months prior to baseline). Screening ALT levels must be normal (
• Positive for HBsAg and HBeAg for more than 6 months prior to baseline
• Detectable HBV-DNA (>20,000 IU/mL) as measured by polymerization chain reaction (PCR) or hybridization on at least 2 occasions at least one month apart with the latest determination obtained less than or equal to ( • Compensated liver disease (Child-Pugh Class A clinical classification)
• Either Liver biopsy performed within 2 years prior to baseline showing no or minimal fibrosis (Liver Biopsy Scores and stable normal ALT levels (less than or equal to upper limit of normal [ULN]) during the 6 months leading up to baseline (including two separate occasions at least 1 month apart over the 6 months prior to baseline). Screening ALT levels must be normal (
Exclusion Criteria
Exclusion Criteria:
• Participants who have received investigational drugs or licensed treatments with anti HBV activity (Exception: Participants who have had a limited [ • Participants who have participated in any other clinical trial or who have received any investigational drug within 6 months prior to baseline
• Known hypersensitivity to interferon (IFN), pegylated interferon-alfa-2a or lamivudine or entecavir
• Positive test results at screening for hepatitis A virus Immunoglobulin M (IgM) antibody (Ab), anti-hepatitis C virus (HCV) Ab, anti- hepatitis D (HDV) Ab or anti-human immunodeficiency virus (HIV) Ab
• Decompensated liver disease (e.g., Child-Pugh Class B or C clinical classification or clinical evidence such as ascites or varices)
• Advanced fibrosis or cirrhosis
• Suspicion of HCC on liver abdominal ultrasound (all patients to have liver abdominal ultrasound within 6 months prior to baseline)
• History or other evidence of a medical condition associated with chronic liver disease other than CHB including metabolic liver diseases such as hemochromatosis, Wilson's disease or alpha-1 anti-trypsin deficiency
• Active substance abuse within 6 months prior to screening
• Sexually active females of childbearing potential and sexually active males who are not willing to utilize reliable contraception during treatment and for 90 days following the end of treatment
• Females who are pregnant or who are breastfeeding (females of childbearing potential who have a positive urine or serum pregnancy test result within 24 hours of baseline are excluded)
• Participants who have received investigational drugs or licensed treatments with anti HBV activity (Exception: Participants who have had a limited [ • Participants who have participated in any other clinical trial or who have received any investigational drug within 6 months prior to baseline
• Known hypersensitivity to interferon (IFN), pegylated interferon-alfa-2a or lamivudine or entecavir
• Positive test results at screening for hepatitis A virus Immunoglobulin M (IgM) antibody (Ab), anti-hepatitis C virus (HCV) Ab, anti- hepatitis D (HDV) Ab or anti-human immunodeficiency virus (HIV) Ab
• Decompensated liver disease (e.g., Child-Pugh Class B or C clinical classification or clinical evidence such as ascites or varices)
• Advanced fibrosis or cirrhosis
• Suspicion of HCC on liver abdominal ultrasound (all patients to have liver abdominal ultrasound within 6 months prior to baseline)
• History or other evidence of a medical condition associated with chronic liver disease other than CHB including metabolic liver diseases such as hemochromatosis, Wilson's disease or alpha-1 anti-trypsin deficiency
• Active substance abuse within 6 months prior to screening
• Sexually active females of childbearing potential and sexually active males who are not willing to utilize reliable contraception during treatment and for 90 days following the end of treatment
• Females who are pregnant or who are breastfeeding (females of childbearing potential who have a positive urine or serum pregnancy test result within 24 hours of baseline are excluded)
The Estimated Number of Participants
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Taiwan
2 participants
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Global
114 participants
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