Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D co-Infection (Study P04603AM3)
This study is ongoing, but not recruiting participants.
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00686790
  Purpose

The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 ug/kg/wk administered for 52 weeks in previously untreated subjects 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 (SCH 54031)
Phase III

MedlinePlus related topics: Hepatitis Hepatitis B
Drug Information available for: Hepatitis B Vaccines Interferon alfa-2b Peginterferon Alfa-2b
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Proportion of subjects with negative HDV-RNA. Normalization of ALT. [ Time Frame: These outcomes will be measured at the end of 52-week treatment and 52-week follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absence of HBV replication (negative serum HBV-DNA, Hbe Ag seroconversion) and at least 2 point decrease in the necrosis inflammation score and no increase or regression of fibrosis in the pre- and post-treatment liver biopsies. [ Time Frame: These outcomes will be measured at the end of the 52-week treatment. ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: December 2005
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental Biological: Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b 1.5 ug/kg/wk SC for 52 weeks

  Eligibility

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

Inclusion Criteria:

  • Subjects 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).
  • Subjects must be free of any clinically significant disease (other than chronic hepatitis B and D), that would interfere with study evaluations.
  • Subjects 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

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P04603
Study First Received: May 27, 2008
Last Updated: December 13, 2008
ClinicalTrials.gov Identifier: NCT00686790  
Health Authority: Romania: National Medicines Agency

Keywords provided by Schering-Plough:
Hepatitis D
Hepatitis B

Study placed in the following topic categories:
Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Hepatitis D, Chronic
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis B, Chronic
Hepatitis B
Peginterferon alfa-2b
Hepatitis D
DNA Virus Infections
Interferon Alfa-2a
Interferon Alfa-2b

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009