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Pegylated Interferon to Treat Chronic Hepatitis D

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier:
NCT00023322
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
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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
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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  
Number of Participants  
[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 )  
ALT [2]
[units: IU/L]
Median ( Full Range )
  141  
  ( 31 to 506 )  
Infection source  
[units: participants]
 
IV Drug Abuse     6  
Sexual     2  
Transfusion     2  
Endemic Region     5  
HDV-RNA [3]
[units: Log10 Genome Equivalent/ml]
Mean ± Standard Deviation
  6.7  ± 1.2  
HBsAg  
[units: Log10 IU/ml]
Mean ± Standard Deviation
  3.7  ± 0.6  
HBV-DNA [4]
[units: Log10 IU/ml]
Median ( Full Range )
  2.9  
  ( 2 to 49 )  
Fibrosis (Ishak score) [5]
[units: Scores on a scale]
Median ( Full Range )
  3  
  ( 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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  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
Study First Received: September 3, 2001
Results First Received: April 15, 2013
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration