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Completed

NCT Number: NCT00536263

PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegylated interferon alpha-2b

Drug

1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks

Primary outcomes

  1. Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss

    Time frame: 24 weeks after end of treatment (EOT)

    HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)

Secondary outcomes

  1. Number of Participants With HBeAg Loss

    Time frame: Up to Treatment Week 48

    HBeAg Loss was tested by assay of Abbott MEIA

  2. HBe Seroconversion

    Time frame: End of treatment (EOT) and 24 weeks after EOT

    HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA.

  3. Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL

    Time frame: End of treatment (EOT) and 24 weeks after EOT

    HBV-DNA was tested by assay of Roche Cobas Taqman (the test

    lowest limit is 6 IU/mL)

  4. Number of Participants With HBV-DNA < 200 IU/mL

    Time frame: End of treatment (EOT) and 24 weeks after EOT

    HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)

  5. Number of Participants With HBV-DNA Undetectable

    Time frame: End of treatment (EOT) and 24 weeks after EOT

    Undetectable HBV-DNA was defined as having a level <6 IU/mL by polymerase chain reaction (PCR).

  6. Number of Participants With Biochemical Response

    Time frame: End of treatment (EOT) and 24 weeks after EOT

    Biochemical response was defined as alanine aminotransferase (ALT) normalization.

  7. Number of Participants With Combined Response

    Time frame: End of treatment (EOT) and 24 weeks after EOT

    Combined response was defined as HBV DNA <20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization

  8. Hepatitis B Surface Antigen (HBsAg) Loss

    Time frame: End of treatment (EOT) and 24 weeks after EOT

    HBsAg Loss was tested by assay of Abbott MEIA

  9. Hepatitis B Surface Antigen (HBs) Seroconversion

    Time frame: End of treatment (EOT) and 24 weeks after EOT

    HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive

  10. Change From Baseline in Liver Biopsy Score

    Time frame: Baseline to 24 weeks after end of treatment

    Method for biopsy scoring was Knodell Scoring System (Histology Activity Index-HAI Score System):

    Score I (periportal +/- bridging necrosis): 0 (none) to 10 (multilobular necrosis).

    Score II (Intralobular degeneration and focal necrosis): 0 (none) to 4 (Marked [involvement of >2/3 of lobules or nodules]).

    Score III (portal inflammation): 0 (none) to 4 (Marked [dense packing of

    inflammatory cells in >2/3 of portal tracts]).

    Score IV (fibrosis): 0 (none) to 4 (cirrhosis).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-label, Randomized Study of PegIntron in the Treatment of HBeAg Positive Chronic Hepatitis B Patients

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 27, 2007
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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