Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pegylated Interferon to Treat Chronic Hepatitis D

This study has been completed.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ) Identifier:
First received: September 3, 2001
Last updated: July 9, 2013
Last verified: July 2013
Results First Received: April 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis D
Intervention: Drug: Peginterferon Alpha-2a

  Participant Flow

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Peginterferon Alpha-2a Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.

Baseline Measures
    Peginterferon Alpha-2a  
Number of Participants  
[units: participants]
[units: years]
Median (Full Range)
  (18 to 58)  
[units: participants]
Female     2  
Male     11  
Race (NIH/OMB)  
[units: participants]
American Indian or Alaska Native     2  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     11  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
United States     13  
Estimated duration of the disease [1]
[units: years]
Median (Full Range)
  (7 to 35)  
ALT [2]
[units: IU/L]
Median (Full Range)
  (31 to 506)  
Infection source  
[units: participants]
IV Drug Abuse     6  
Sexual     2  
Transfusion     2  
Endemic Region     5  
[units: Log10 Genome Equivalent/ml]
Mean (Standard Deviation)
  6.7  (1.2)  
[units: Log10 IU/ml]
Mean (Standard Deviation)
  3.7  (0.6)  
[units: Log10 IU/ml]
Median (Full Range)
  (2 to 49)  
Fibrosis (Ishak score) [5]
[units: Scores on a scale]
Median (Full Range)
  (3 to 6)  
[1] Estimated duration of the HDV infection
[2] alanine aminotransferase
[3] hepatitis D virus RNA
[4] hepatitis B virus DNA
[5] Possible range of Ishak score is 0 to 6. Higher values indicate worse outcome.

  Outcome Measures
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1.  Primary:   Histological Response at 3 Years   [ Time Frame: 3 years ]

2.  Secondary:   Histological Response at 5 Years   [ Time Frame: 5 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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