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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
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.

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
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
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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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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.

Other Adverse Events
    Peginterferon Alpha-2a
Total, other (not including serious) adverse events   
# participants affected / at risk   3/12 (25.00%) 
Blood and lymphatic system disorders   
subarachnoid hemorrhage [1]   
# participants affected / at risk   1/12 (8.33%) 
# events   1 
Infections and infestations   
autoinflammatory syndrome   
# participants affected / at risk   1/12 (8.33%) 
# events   1 
Skin and subcutaneous tissue disorders   
soft tissue infection   
# participants affected / at risk   1/12 (8.33%) 
# events   1 
[1] subarachnoid hemorrhage from an arteriovenous malformation



  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
No text entered.


  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 )
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