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Pegylated Interferon to Treat Chronic Hepatitis D

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ClinicalTrials.gov Identifier: NCT00023322
Recruitment Status : Completed
First Posted : September 3, 2001
Results First Posted : July 10, 2013
Last Update Posted : July 10, 2013
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hepatitis D
Intervention: Drug: Peginterferon Alpha-2a

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between October 2002 and June 2006, 13 patients were recruited into the study. The location is NIH clinical center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Peginterferon Alpha-2a
STARTED   13 
COMPLETED   12 
NOT COMPLETED   1 
Lost to Follow-up                1 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
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 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Years]
Median (Full Range)
 42 
 (18 to 58) 
Gender 
[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)
 25 
 (7 to 35) 
[1] Estimated duration of the HDV infection
ALT [1] 
[Units: IU/L]
Median (Full Range)
 141 
 (31 to 506) 
[1] alanine aminotransferase
Infection source 
[Units: Participants]
 
IV Drug Abuse   6 
Sexual   2 
Transfusion   2 
Endemic Region   5 
HDV-RNA [1] 
[Units: Log10 Genome Equivalent/ml]
Mean (Standard Deviation)
 6.7  (1.2) 
[1] hepatitis D virus RNA
HBsAg 
[Units: Log10 IU/ml]
Mean (Standard Deviation)
 3.7  (0.6) 
HBV-DNA [1] 
[Units: Log10 IU/ml]
Median (Full Range)
 2.9 
 (2 to 49) 
[1] hepatitis B virus DNA
Fibrosis (Ishak score) [1] 
[Units: Scores on a scale]
Median (Full Range)
 3 
 (3 to 6) 
[1] Possible range of Ishak score is 0 to 6. Higher values indicate worse outcome.


  Outcome Measures

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

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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  More Information