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Pegylated Interferon to Treat Chronic Hepatitis D

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00023322
First Posted: September 3, 2001
Last Update Posted: July 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
Results First Submitted: April 15, 2013  
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


  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.
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
  Show All 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
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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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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Theo Heller, M.D.
Organization: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
phone: (301) 402-7147
e-mail: Theoh@mail.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT00023322     History of Changes
Other Study ID Numbers: 010247
01-DK-0247 ( Other Identifier: National Institutes of Health )
First Submitted: September 3, 2001
First Posted: September 3, 2001
Results First Submitted: April 15, 2013
Results First Posted: July 10, 2013
Last Update Posted: July 10, 2013