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Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603AM3)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00686790
First received: May 27, 2008
Last updated: March 24, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis D, Chronic
Hepatitis B, Chronic
 Biological: Peginterferon alfa-2b (PegIntron, SCH 54031)
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Uncontrolled, Study to Assess the Response of Peg-Intron in naïve Patients With Chronic Hepatitis B and D Co-infection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With a Biochemical Response [ Time Frame: 52 weeks (EOT), 104 weeks (EOF) ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With a Combined Response [ Time Frame: 52 weeks (EOT), 104 weeks (EOF) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response) [ Time Frame: 52 week (EOT) ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With a Liver Histology Response [ Time Frame: Baseline and 52 week (EOT) ] [ Designated as safety issue: No ]

    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.



Enrollment: 68
Study Start Date: December 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PegIntron
All participants received PegIntron (Peginterferon alfa-2b) weekly based on their body weight.
 Biological: Peginterferon alfa-2b (PegIntron, SCH 54031)
Peginterferon alfa-2b 1.5 mcg/kg/wk subcutaneously (SC) for 52 weeks.
Other Name: SCH 54031, PegIntron

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00686790     History of Changes
Other Study ID Numbers: P04603
Study First Received: May 27, 2008
Results First Received: December 21, 2010
Last Updated: March 24, 2011
Health Authority: Romania: National Medicines Agency

Keywords provided by Schering-Plough:
Hepatitis D
Hepatitis B

Additional relevant MeSH terms:
Hepatitis D
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis D, Chronic
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Liver Diseases
Digestive System Diseases
 Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013