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Trial record 23 of 25 for:    "Liver Cirrhosis" | "Peginterferon alfa-2a"

Pegylated Interferon to Treat Chronic Hepatitis D

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.
 
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):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

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
Enrollment 13
Recruitment Details Between October 2002 and June 2006, 13 patients were recruited into the study. The location is NIH clinical center.
Pre-assignment Details  
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 13
Completed 12
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
42
(18 to 58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
2
  15.4%
Male
11
  84.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
2
  15.4%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
11
  84.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
Estimated duration of the disease   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
25
(7 to 35)
[1]
Measure Description: Estimated duration of the HDV infection
ALT   [1] 
Median (Full Range)
Unit of measure:  IU/L
Number Analyzed 13 participants
141
(31 to 506)
[1]
Measure Description: alanine aminotransferase
Infection source  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants
IV Drug Abuse 6
Sexual 2
Transfusion 2
Endemic Region 5
HDV-RNA   [1] 
Mean (Standard Deviation)
Unit of measure:  Log10 Genome Equivalent/ml
Number Analyzed 13 participants
6.7  (1.2)
[1]
Measure Description: hepatitis D virus RNA
HBsAg  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/ml
Number Analyzed 13 participants
3.7  (0.6)
HBV-DNA   [1] 
Median (Full Range)
Unit of measure:  Log10 IU/ml
Number Analyzed 13 participants
2.9
(2 to 49)
[1]
Measure Description: hepatitis B virus DNA
Fibrosis (Ishak score)   [1] 
Median (Full Range)
Unit of measure:  Scores on a scale
Number Analyzed 13 participants
3
(3 to 6)
[1]
Measure Description: Possible range of Ishak score is 0 to 6. Higher values indicate worse outcome.
1.Primary Outcome
Title Histological Response at 3 Years
Hide Description Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
6
2.Secondary Outcome
Title Histological Response at 5 Years
Hide Description Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description 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.
All-Cause Mortality
Peginterferon Alpha-2a
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Peginterferon Alpha-2a
Affected / at Risk (%) # Events
Total   1/12 (8.33%)    
Hepatobiliary disorders   
Death  [1]  1/12 (8.33%)  1
Death  [2]  1/12 (8.33%)  1
Indicates events were collected by systematic assessment
[1]
hepatocellular carcinoma
[2]
hepatic decompensation secondary to herpes colitis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Peginterferon Alpha-2a
Affected / at Risk (%) # Events
Total   3/12 (25.00%)    
Blood and lymphatic system disorders   
subarachnoid hemorrhage [1]  1/12 (8.33%)  1
Infections and infestations   
autoinflammatory syndrome  1/12 (8.33%)  1
Skin and subcutaneous tissue disorders   
soft tissue infection  1/12 (8.33%)  1
[1]
subarachnoid hemorrhage from an arteriovenous malformation
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Theo Heller, M.D.
Organization: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (301) 402-7147
EMail: Theoh@mail.nih.gov
Layout table for additonal information
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