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Completed

NCT Number: NCT00686790

Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)

The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic, biochemical, and histological response will be evaluated.

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Key information

Conditions

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

  • Participants must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
  • Age 18-65 years old.
  • HBsAg positive >6 months.
  • ALT >= 2 ULN >6 months.
  • HDV RNA positive serology.
  • Serum antibody to hepatitis delta antigen of IgG and IgM class.
  • Knodell score HAI >= 6 and F >= 0; positive test for intrahepatic Delta antigen in liver biopsy.
  • Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
  • Participants must be free of any clinically significant disease (other than chronic hepatitis B and D), that would interfere with study evaluations.
  • Participants must understand and be able to adhere to the dosing and visit schedules, and agree to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.

Exclusion criteria

  • Age <18 and >65.
  • Concomitant HCV and/or HIV infection.
  • Actual liver failure (total serum bilirubin >2.5 x normal, prolonged prothrombin time >3 sec, serum albumin <3 g/dl, history of ascites, variceal bleeding, or hepatic encephalopathy).
  • Toxic or autoimmune hepatitis (ANA titers > 1:160), metabolic liver diseases (Wilson disease, hemochromatosis, α-1 antitrypsin deficiency)
  • Women who are pregnant or nursing.
  • Leukopenia (<2500/mm^3), neutropenia (<1000/mm^3), hemoglobin <10 g/dl, presence of other severe diseases (myocardiopathy, diabetes mellitus, arterial hypertension, neoplasia, neurologic diseases, malnutrition).
  • Antiviral, immunomodulatory, corticosteroid, or chemotherapeutical treatment within 6 months of the participation in the study.
  • Depression and/or psychiatric disorders.

Treatment and study plan

Peginterferon alfa-2b (PegIntron, SCH 54031)

Biological

Peginterferon alfa-2b 1.5 mcg/kg/wk subcutaneously (SC) for 52 weeks.

Other names: SCH 54031, PegIntron

Primary outcomes

  1. Number of Participants With a Virological Response

    Time frame: 52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation

    For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT).

  2. Number of Participants With a Biochemical Response

    Time frame: 52 weeks (EOT), 104 weeks (EOF)

    A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L.

  3. Number of Participants With a Combined Response

    Time frame: 52 weeks (EOT), 104 weeks (EOF)

    The combined response was defined as an ALT level below the upper

    reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L.

Secondary outcomes

  1. Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response)

    Time frame: 52 week (EOT)

    Serum samples collected from the participants were tested by PCR to detect HBV-DNA. HBV response was defined as the absence of HBV-deoxyribonucleic acid (HBV-DNA) in serum.

  2. Number of Participants With a Liver Histology Response

    Time frame: Baseline and 52 week (EOT)

    The liver histology response was defined as at least a 2 point decrease in the necrosis inflammation score (a sum of periportal necrosis [0-10], lobular inflammation [0-4], portal inflammation [0-4], with the total score of 18 representing the worst outcome) and no increase or regression of fibrosis (scored [0-4]) in the pre- and post-treatment liver biopsies.

    The efficacy of treatment based on histological response was assessed by the investigator as complete response, partial response, minimal response, progressive disease, and not assessable at EOT.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open Label, Uncontrolled, Study to Assess the Response of Peg-Intron in naïve Patients With Chronic Hepatitis B and D Co-infection

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
May 30, 2008
Registry last updated
Apr 6, 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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