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SOFIA-LTT Study: A Study of Intermittent Long Term Treatment With PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Negative Chronic Hepatitis B (CHB).

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ClinicalTrials.gov Identifier: NCT00442572
Recruitment Status : Completed
First Posted : March 2, 2007
Results First Posted : April 11, 2016
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hepatitis B, Chronic
Intervention: Drug: PEGASYS [peginterferon alfa-2a]

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All participants in this study were enrolled at one centre in Bulgaria from 03 July 2006 to 23 April 2012. Of the 21 participants enrolled, 17 participants were randomized to PEGASYS arm and 4 participants were randomized to no intervention arm.

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
PEGASYS Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a (PEGASYS®). Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms (µg) in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously (SC) and followed by 12 weeks period without treatment.
No Intervention Participants were on non- specific anti-viral treatment.

Participant Flow:   Overall Study
    PEGASYS   No Intervention
STARTED   17   4 
COMPLETED   9   1 
NOT COMPLETED   8   3 
Relapse                8                1 
Lost to Follow-up                0                1 
Withdrawal by Subject                0                1 



  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.
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.

Reporting Groups
  Description
PEGASYS Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
No Intervention Participants were on non- specific anti-viral treatment.
Total Total of all reporting groups

Baseline Measures
   PEGASYS   No Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   4   21 
Age 
[Units: Years]
Median (Full Range)
 44 
 (23 to 61) 
 38.5 
 (22 to 50) 
 42 
 (22 to 61) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  41.2%      0   0.0%      7  33.3% 
Male      10  58.8%      4 100.0%      14  66.7% 


  Outcome Measures

1.  Primary:   Percentage of Participants With Stable Virological Response   [ Time Frame: Up to Week 108 ]

2.  Secondary:   Percentage of Participants With Stable Virological and Biochemical Response   [ Time Frame: Up to Week 108 ]

3.  Secondary:   Percentage of Participants With Loss of Hepatitis B Surface Antigen   [ Time Frame: Up to Week 108 ]

4.  Secondary:   Percentage of Participants With HBsAg Seroconversion   [ Time Frame: Up to Week 108 ]

5.  Secondary:   Percentage of Participants With HBV DNA Levels Under the Lower Limit (Serum HBV DNA Level < 300 Copies/ml) For a Significant Quantity   [ Time Frame: Up to Week 108 ]

6.  Secondary:   Fibrosis-4 and Aspartate Aminotransferase to Platelet Ratio Index Scores For Change in Liver Fibrosis   [ Time Frame: Up to Week 108 ]

7.  Secondary:   Mean Change From Baseline in HBsAg Levels   [ Time Frame: Up to Week 108 ]

8.  Secondary:   Mean Change From Baseline in Hemoglobin   [ Time Frame: Up to Week 108 ]

9.  Secondary:   Mean Change From Baseline in Hematology   [ Time Frame: Up to Week 108 ]

10.  Secondary:   Mean Change From Baseline in Clinical Chemistry   [ Time Frame: Up to Week 108 ]

11.  Secondary:   Mean Change From Baseline in Protein and Indirect Albumin   [ Time Frame: Up to Week 108 ]

12.  Secondary:   Mean Change From Baseline in Bilirubin Indirect and Bilirubin Direct   [ Time Frame: Up to Week 108 ]

13.  Secondary:   Mean Change From Baseline in Blood Urea   [ Time Frame: Up to Week 108 ]

14.  Secondary:   Mean Change From Baseline in Creatinine and Uric Acid   [ Time Frame: Up to Week 108 ]

15.  Secondary:   Mean Change From Baseline in Blood Glucose   [ Time Frame: Up to Week 108 ]

16.  Secondary:   Mean Change From Baseline in Thyroid Stimulating Hormone (TSH)   [ Time Frame: Up to Week 108 ]

17.  Secondary:   Mean Change From Baseline in Triiodothyronine and Thyroxine   [ Time Frame: Up to Week 108 ]


  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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 61 6878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00442572     History of Changes
Other Study ID Numbers: ML20020
First Submitted: February 15, 2007
First Posted: March 2, 2007
Results First Submitted: December 8, 2015
Results First Posted: April 11, 2016
Last Update Posted: April 6, 2017