A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B

Hepatitis B, Chronic Clinical Trial

Official title:

A Study on Optimizing HBeAg Seroconversion in HBeAg Positive CHB Patients With Combination or Sequential Treatment of Pegylated Interferon Alpha-2a and Entecavir

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940485
• Other study ID #: ML22265
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2009
• Last updated: January 24, 2016
• Start date: April 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients, >=18 and </= 65 years of age

• HBeAg positive chronic hepatitis B

• Pre-treatment with entecavir for 9-36 months

Exclusion Criteria:

• Antiviral, antineoplastic or immunomodulatory treatment

• Co-infection with active hepatitis A, C or D, or HIV

• Evidence of decompensated liver disease

• History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• entecavir
0.5mg po daily for 8 weeks
• entecavir
0.5mg po daily for 48 weeks
• peginterferon alfa-2a [Pegasys]
180 micrograms sc/week for 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion	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).	Week 48	No
Secondary	Percentage of Participants With Loss of Hepatitis B Envelope Antigen	Loss of Hepatitis B Envelope Antigen (HBeAg) is defined as the absence of HBeAg.	Week 48	No
Secondary	Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre	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.	Week 48	No
Secondary	Percentage of Participants With Hepatitis B Surface Antigen Loss	Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.	Week 48	No
Secondary	Percentage of Participants With Hepatitis B Surface Antigen Seroconversion	Hepatitis B Surface Antigen (HBsAg) seroconversion was defined as loss of HBsAg and presence of anti-HBs .(antibody to Hepatitis B surface antigen)	Week 48	No
Secondary	Percentage of Participants With Normalized Alanine Aminotransferase	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.	Week 48	No
Secondary	Quantitative Hepatitis B Envelope Antigen Reduction	Quantitative 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).	Up to Week 48	No
Secondary	Quantitative Hepatitis B Surface Antigen Reduction	Quantitative 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)	Up to Week 48	No
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.	Up to Week 48	No
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.	Up to Week 48	No