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Trial record 52 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program

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ClinicalTrials.gov Identifier: NCT02791269
Recruitment Status : Completed
First Posted : June 6, 2016
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis B, Chronic
Intervention Drug: Peginterferon alfa-2a
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HBeAg Negative Participants HBeAg Positive Participants
Hide Arm/Group Description Hepatitis B e antigen (HBeAg) negative participants received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period. HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
Period Title: Overall Study
Started 4 20
Completed 4 19
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title HBeAg Negative Participants HBeAg Positive Participants Total
Hide Arm/Group Description HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period. HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period. Total of all reporting groups
Overall Number of Baseline Participants 4 20 24
Hide Baseline Analysis Population Description
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 20 participants 24 participants
43.25  (5.75) 31.57  (9.43) 33.52  (9.88)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 20 participants 24 participants
Female
0
   0.0%
7
  35.0%
7
  29.2%
Male
4
 100.0%
13
  65.0%
17
  70.8%
1.Primary Outcome
Title Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL)
Hide Description HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests.
Time Frame End of 24-weeks follow-up (Week 72)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had one subsequent post baseline assessment. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome.
Arm/Group Title HBeAg Positive Participants
Hide Arm/Group Description:
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
7
2.Primary Outcome
Title Number of Participants With HBV-DNA <20,000 Copies/mL
Hide Description HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
Time Frame End of 24-weeks follow-up (Week 72)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome.
Arm/Group Title HBeAg Negative Participants HBeAg Positive Participants
Hide Arm/Group Description:
HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
Overall Number of Participants Analyzed 3 17
Measure Type: Number
Unit of Measure: participants
0 3
3.Secondary Outcome
Title Number of Participants With HBV-DNA <400 Copies/mL
Hide Description HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
Time Frame Week 48 (end of treatment) and Week 72 (end of follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.
Arm/Group Title HBeAg Negative Participants HBeAg Positive Participants
Hide Arm/Group Description:
HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
Overall Number of Participants Analyzed 4 18
Measure Type: Number
Unit of Measure: participants
Week 48 (n=4,18) 3 6
Week 72 (n=3,17) 0 2
4.Secondary Outcome
Title Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion
Hide Description HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Both HBeAg positive and negative participants were HBsAg positive at baseline and absence of HBsAg (seroconversion) was analyzed.
Time Frame Week 48 (end of treatment) and Week 72 (end of follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.
Arm/Group Title HBeAg Negative Participants HBeAg Positive Participants
Hide Arm/Group Description:
HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
Overall Number of Participants Analyzed 4 15
Measure Type: Number
Unit of Measure: participants
Week 48 (n=4,15) 0 0
Week 72 (n=4,13) 0 0
5.Secondary Outcome
Title Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level
Hide Description ALT is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT level increases. Normal ALT level = less than upper limit of normal (40 units per liter).
Time Frame Week 48 (end of treatment) and Week 72 (end of follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.
Arm/Group Title HBeAg Negative Participants HBeAg Positive Participants
Hide Arm/Group Description:
HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
Overall Number of Participants Analyzed 4 19
Measure Type: Number
Unit of Measure: participants
Week 48 (n=4,19) 2 4
Week 72 (n=4,17) 4 7
6.Secondary Outcome
Title Number of Participants With HBeAg Seroconversion
Hide Description HBeAg seroconversion for HBeAg positive participants was defined as the loss of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe).
Time Frame Week 48 (end of treatment) and Week 72 (end of follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only HBeAg positive participants was planned to be reported. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.
Arm/Group Title HBeAg Positive Participants
Hide Arm/Group Description:
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: participants
Week 48 (n=19) 6
Week 72 (n=17) 6
Time Frame Baseline up to end of follow-up period (Approximately 72 weeks)
Adverse Event Reporting Description Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
 
Arm/Group Title HBeAg Negative Participants HBeAg Positive Participants
Hide Arm/Group Description HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period. HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
All-Cause Mortality
HBeAg Negative Participants HBeAg Positive Participants
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HBeAg Negative Participants HBeAg Positive Participants
Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)   0/20 (0.00%) 
Cardiac disorders     
chest pain * 1  1/4 (25.00%)  0/20 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HBeAg Negative Participants HBeAg Positive Participants
Affected / at Risk (%) Affected / at Risk (%)
Total   3/4 (75.00%)   7/20 (35.00%) 
Endocrine disorders     
Hypothyroidism * 1  0/4 (0.00%)  1/20 (5.00%) 
Eye disorders     
Glaucoma * 1  0/4 (0.00%)  1/20 (5.00%) 
Eye infection * 1  0/4 (0.00%)  1/20 (5.00%) 
General disorders     
Tiredness * 1  1/4 (25.00%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders     
Muscle spasm * 1  0/4 (0.00%)  1/20 (5.00%) 
Nervous system disorders     
Depression * 1  2/4 (50.00%)  1/20 (5.00%) 
Mood disturbance * 1  1/4 (25.00%)  1/20 (5.00%) 
Psychiatric disorders     
Insomnia * 1  1/4 (25.00%)  0/20 (0.00%) 
Renal and urinary disorders     
Urinary frequency * 1  1/4 (25.00%)  0/20 (0.00%) 
Reproductive system and breast disorders     
Blood in semen * 1  0/4 (0.00%)  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders     
Non-productive cough * 1  1/4 (25.00%)  0/20 (0.00%) 
Sore throat * 1  0/4 (0.00%)  1/20 (5.00%) 
Skin and subcutaneous tissue disorders     
Rash * 1  1/4 (25.00%)  0/20 (0.00%) 
Itchy skin * 1  0/4 (0.00%)  1/20 (5.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02791269     History of Changes
Other Study ID Numbers: ML19295
First Submitted: May 31, 2016
First Posted: June 6, 2016
Results First Submitted: August 26, 2016
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017