Clinical trial NCT00536263: PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
Official title: An Open-label, Randomized Study of PegIntron in the Treatment of HBeAg Positive Chronic Hepatitis B Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-27
Enrollment: 671
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks. This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks after their treatment ends.


Eligibility criteria: Inclusion Criteria:

* Adults with chronic hepatitis B:

  * Serum hepatitis B surface antigen positive for at least 6 months
  * Serum hepatitis B e antigen positive
  * Serum negative for hepatitis B surface and e antibodies
  * Plasma hepatitis B virus deoxyribonucleic acid (DNA) level greater than 20,000 IU/mL
  * Alanine aminotransferase (ALT) 2- to 10-times the upper limit of normal
* Compensated liver disease with certain minimum hematological and serum biochemical criteria

Exclusion Criteria:

* Significant hepatic disease from an etiology other than hepatitis B virus
* Antiviral treatment for hepatitis within previous 6 months
* History of severe psychiatric disease, especially depression
* Unstable or significant cardiovascular disease
* Prolonged exposure to known hepatotoxins such as alcohol or drugs
* Any condition that could interfere with the subject participating in and completing the study

Primary outcomes:
measure: Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss
timeFrame: 24 weeks after end of treatment (EOT)
Secondary outcomes:
measure: Number of Participants With HBeAg Loss
timeFrame: Up to Treatment Week 48
measure: HBe Seroconversion
timeFrame: End of treatment (EOT) and 24 weeks after EOT
measure: Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL
timeFrame: End of treatment (EOT) and 24 weeks after EOT
measure: Number of Participants With HBV-DNA < 200 IU/mL
timeFrame: End of treatment (EOT) and 24 weeks after EOT
measure: Number of Participants With HBV-DNA Undetectable
timeFrame: End of treatment (EOT) and 24 weeks after EOT
measure: Number of Participants With Biochemical Response
timeFrame: End of treatment (EOT) and 24 weeks after EOT
measure: Number of Participants With Combined Response
timeFrame: End of treatment (EOT) and 24 weeks after EOT
measure: Hepatitis B Surface Antigen (HBsAg) Loss
timeFrame: End of treatment (EOT) and 24 weeks after EOT
measure: Hepatitis B Surface Antigen (HBs) Seroconversion
timeFrame: End of treatment (EOT) and 24 weeks after EOT
measure: Change From Baseline in Liver Biopsy Score
timeFrame: Baseline to 24 weeks after end of treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Cheng J, Wang Y, Hou J, Luo D, Xie Q, Ning Q, Ren H, Ding H, Sheng J, Wei L, Chen S, Fan X, Huang W, Pan C, Gao Z, Zhang J, Zhou B, Chen G, Wan M, Tang H, Wang G, Yang Y, Mohamed R, Guan R, Lee TH, Chang WH, Zhenfei H, Ye Z, Xu D. Peginterferon alfa-2b in the treatment of Chinese patients with HBeAg-positive chronic hepatitis B: a randomized trial. J Clin Virol. 2014 Dec;61(4):509-16. doi: 10.1016/j.jcv.2014.08.008. Epub 2014 Aug 18.