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A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays

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ClinicalTrials.gov Identifier: NCT01098006
Recruitment Status : Completed
First Posted : April 2, 2010
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Immunologic Tests
Intervention: Other: Blood withdrawal

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Group 1 Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
Group 2 HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
Group 3 Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
Group 4 HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.

Participant Flow:   Overall Study
    Group 1   Group 2   Group 3   Group 4
STARTED   7   11   60   21 
COMPLETED   7   11   60   21 
NOT COMPLETED   0   0   0   0 



  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
Group 1 Immune tolerant patients aged between and including 18 and 65 years of age at study start, having high levels of hepatitis B virus (HBV) replication characterized by elevated HBV DNA levels and presence of hepatitis B envelope antigen (HBeAg), but normal alanine aminotransferase (ALT) levels with normal or mild histology findings.
Group 2 HBeAg positive chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having elevated or fluctuating ALT levels, presence of HBeAg and variable HBV DNA on a high level, histology mainly with active inflammation and varying degrees of liver fibrosis.
Group 3 Inactive carriers aged between and including 18 and 65 years of age at study start, having normal ALT levels, undetectable or low levels of serum HBV DNA; absence of HBeAg and presence of anti-HBe antibodies, histology with little or no inflammation and varying degrees of liver fibrosis.
Group 4 HBeAg negative chronic Hepatitis B patients aged between and including 18 and 65 years of age at study start, having absence of HBeAg, presence of anti-HBe, elevated ALT and HBV DNA levels, histology with significant inflammatory changes, liver fibrosis and cirrhosis.
Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Group 3   Group 4   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   11   60   21   99 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.4  (6.0)   34.0  (14.2)   36.9  (8.7)   39.7  (15.1)   36.43  (11.19) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      3  42.9%      4  36.4%      25  41.7%      5  23.8%      37  37.4% 
Male      4  57.1%      7  63.6%      35  58.3%      16  76.2%      62  62.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
         
Geographic Ancestry           
African heritage/African American      5  71.4%      2  18.2%      31  51.7%      9  42.9%      47  47.5% 
Asian-Central/South Asian heritage      0   0.0%      2  18.2%      1   1.7%      0   0.0%      3   3.0% 
Asian-East Asian heritage      1  14.3%      2  18.2%      2   3.3%      0   0.0%      5   5.1% 
White-Arabic/North African heritage      0   0.0%      0   0.0%      11  18.3%      7  33.3%      18  18.2% 
White-Caucasian/European heritage      0   0.0%      5  45.5%      15  25.0%      4  19.0%      24  24.2% 
Other: Kazakstan      1  14.3%      0   0.0%      0   0.0%      0   0.0%      1   1.0% 
Other: Latino      0   0.0%      0   0.0%      0   0.0%      1   4.8%      1   1.0% 


  Outcome Measures

1.  Primary:   Frequency of Cluster of Differentiation 4 (CD4) + Foxhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1.   [ Time Frame: At Day 0 ]

2.  Primary:   Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1.   [ Time Frame: At Day 0 ]

3.  Primary:   Frequency of CD4+Foxp3+ Expressing CD45RA and/or GITR and/or Ki67.   [ Time Frame: At Day 0 ]

4.  Primary:   Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67.   [ Time Frame: At Day 0 ]

5.  Primary:   Frequency of CD4+Foxp3+ Expressing CD45RA and/or CCR7 and/or CD62L.   [ Time Frame: At Day 0 ]

6.  Primary:   Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L.   [ Time Frame: At Day 0 ]

7.  Primary:   Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or TNFR2.   [ Time Frame: At Day 0 ]

8.  Primary:   Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2.   [ Time Frame: At Day 0 ]

9.  Primary:   Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40.   [ Time Frame: At Day 0 ]

10.  Primary:   Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40.   [ Time Frame: At Day 0 ]

11.  Primary:   Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples.   [ Time Frame: At Day 0 ]

12.  Primary:   Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples.   [ Time Frame: At Day 0 ]

13.  Primary:   Frequency of HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Frozen Samples.   [ Time Frame: At Day 0 ]

14.  Secondary:   Frequency of CD4+ Expressing CD40-L and/or IFNg and/or Interleukin Receptor 2 (IL-2) and/or IL-17 in Fresh Samples.   [ Time Frame: At Day 0 ]

15.  Secondary:   Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples.   [ Time Frame: At Day 0 ]

16.  Secondary:   Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples.   [ Time Frame: At Day 0 ]

17.  Secondary:   Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples.   [ Time Frame: At Day 0 ]


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01098006     History of Changes
Other Study ID Numbers: 113854
First Submitted: April 1, 2010
First Posted: April 2, 2010
Results First Submitted: May 24, 2017
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017