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
  Hide 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
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


  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
  Hide 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
No text entered.


  More Information
  Hide More Information

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