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Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B (HBRN)

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ClinicalTrials.gov Identifier: NCT01369199
Recruitment Status : Terminated
First Posted : June 8, 2011
Results First Posted : July 3, 2018
Last Update Posted : September 21, 2018
Sponsor:
Collaborators:
University of Pittsburgh
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
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 B
Intervention: Drug: Entecavir and peginterferon

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty-eight (28) adults were enrolled at 11 clinical sites in the United States and Canada between 12/18/12 and 04/29/15.

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 and Entecavir Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up for 48 weeks.

Participant Flow:   Overall Study
    Peginterferon and Entecavir
STARTED   28 
End of Treatment (EOT)   26 [1] 
COMPLETED [2]   25 
NOT COMPLETED   3 
Withdrawal by Subject                1 
Lost to Follow-up                2 
[1] 1 withdrew consent before treatment,1 missed end of treatment (EOT) visit but completed follow-up.
[2] End of follow-up



  Baseline Characteristics

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 and Entecavir Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Baseline Measures
   Peginterferon and Entecavir 
Overall Participants Analyzed 
[Units: Participants]
 28 
Age 
[Units: Years]
Median (Full Range)
 37.2 
 (22.2 to 61.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  46.4% 
Male      15  53.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Asian   27 
Black/African American   1 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
Canada   9 
United States   19 
Hepatitis B Virus (HBV) DNA 
[Units: Log10 IU/mL]
Median (Full Range)
 8.2 
 (7.2 to 8.8) 


  Outcome Measures

1.  Primary:   Proportion of Participants With HBeAg Loss (Lack of Detectable HBeAg) AND HBV DNA ≤1,000 IU/mL   [ Time Frame: End of follow-up (up to 96 weeks) ]

2.  Primary:   Incidence of Adverse Events (AEs) Per Person-Year of Observation   [ Time Frame: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks) ]

3.  Primary:   Incidence of Serious Adverse Events (SAEs) Per Person-Year   [ Time Frame: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks) ]

4.  Secondary:   Proportion of Participants With HBeAg Loss   [ Time Frame: End of treatment (up to 48 weeks) ]

5.  Secondary:   Proportion of Participants With HBeAg Loss   [ Time Frame: End of follow-up (up to 96 weeks) ]

6.  Secondary:   Proportion of Participants With HBeAg Seroconversion   [ Time Frame: End of treatment (up to 48 weeks) ]

7.  Secondary:   Proportion of Participants With HBeAg Seroconversion   [ Time Frame: End of follow-up (up to 96 weeks) ]

8.  Secondary:   Proportion of Participants With HBsAg Loss   [ Time Frame: End of treatment (up to 48 weeks) ]

9.  Secondary:   Proportion of Participants With HBsAg Loss   [ Time Frame: End of follow-up (up to 96 weeks) ]

10.  Secondary:   Proportion of Participants With HBsAg Seroconversion   [ Time Frame: End of treatment (up to 48 weeks) ]

11.  Secondary:   Proportion of Participants With HBsAg Seroconversion   [ Time Frame: End of follow-up (up to 96 weeks) ]

12.  Secondary:   Proportion of Participants With Alanine Aminotransferase (ALT) <45 U/L for Men, <30 U/L for Women   [ Time Frame: End of treatment (up to 48 weeks) ]

13.  Secondary:   Proportion of Participants With ALT <45 U/L for Men, <30 U/L for Women   [ Time Frame: End of follow-up (up to 96 weeks) ]

14.  Secondary:   Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)   [ Time Frame: End of treatment (up to 48 weeks) ]

15.  Secondary:   Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)   [ Time Frame: End of follow-up (up to 96 weeks) ]

16.  Secondary:   Proportion of Participants With HBV DNA ≤1000 IU/mL   [ Time Frame: End of treatment (up to 48 weeks) ]

17.  Secondary:   Proportion of Participants With HBV DNA ≤1000 IU/mL   [ Time Frame: End of follow-up (up to 96 weeks) ]

18.  Secondary:   Proportion of Participants With HBV DNA <20 IU/mL   [ Time Frame: End of treatment (up to 48 weeks) ]

19.  Secondary:   Proportion of Participants With HBV DNA <20 IU/mL   [ Time Frame: End of follow-up (up to 96 weeks) ]

20.  Secondary:   Absence of Detectable Antiviral Drug-resistance HBV Mutations   [ Time Frame: End of treatment (up to 48 weeks) ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  


  Serious Adverse Events


  Other Adverse Events


  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

Early termination of recruitment per Data and Safety Monitoring Board.

1 case with multiple central and local lab discrepancies was not considered to have HBeAg loss since central lab was always negative.



  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Steven Belle
Organization: University of Pittsburgh
phone: 412-624-5419
e-mail: belle@edc.pitt.edu



Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT01369199     History of Changes
Obsolete Identifiers: NCT01534611
Other Study ID Numbers: DK082864 HBRN IT Adult Trial
U01DK082916 ( U.S. NIH Grant/Contract )
U01DK082843 ( U.S. NIH Grant/Contract )
U01DK082863 ( U.S. NIH Grant/Contract )
U01DK082864 ( U.S. NIH Grant/Contract )
U01DK082866 ( U.S. NIH Grant/Contract )
U01DK082867 ( U.S. NIH Grant/Contract )
U01DK082871 ( U.S. NIH Grant/Contract )
U01DK082872 ( U.S. NIH Grant/Contract )
U01DK082874 ( U.S. NIH Grant/Contract )
U01DK082919 ( U.S. NIH Grant/Contract )
U01DK082923 ( U.S. NIH Grant/Contract )
U01DK082927 ( U.S. NIH Grant/Contract )
U01DK082943 ( U.S. NIH Grant/Contract )
U01DK082944 ( U.S. NIH Grant/Contract )
P30DK050306 ( U.S. NIH Grant/Contract )
A-DK-3002-001 ( Other Grant/Funding Number: Interagency agreement with NIDDK )
M01RR000040 ( U.S. NIH Grant/Contract )
UL1TR000058 ( U.S. NIH Grant/Contract )
UL1TR000004 ( U.S. NIH Grant/Contract )
UL1TR001111 ( U.S. NIH Grant/Contract )
UL1RR024986 ( U.S. NIH Grant/Contract )
First Submitted: June 6, 2011
First Posted: June 8, 2011
Results First Submitted: March 7, 2018
Results First Posted: July 3, 2018
Last Update Posted: September 21, 2018