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Trial record 62 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression

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ClinicalTrials.gov Identifier: NCT01706575
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : August 5, 2016
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis B, Chronic
Interventions Drug: Pegylated Interferon (Peginterferon) Alfa-2a
Drug: Nucleos(t)ide Analogues (NA)
Enrollment 76
Recruitment Details  
Pre-assignment Details A total of 76 participants started the study and were included in lead-in period. Out of 76 participants, 70 received study drug.
Arm/Group Title Pegylated Interferon (Peginterferon) Alfa-2a
Hide Arm/Group Description Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
Period Title: Overall Study
Started 76
Treated 70
Completed 64
Not Completed 12
Reason Not Completed
Participant Withdrew Consent             4
Lost to Follow-up             2
Started but not Treated             6
Arm/Group Title Pegylated Interferon (Peginterferon) Alfa-2a
Hide Arm/Group Description Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
Overall Number of Baseline Participants 76
Hide Baseline Analysis Population Description
Lead-in participants included all participants enrolled in lead-in period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants
49.82  (8.46)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants
Female
13
  17.1%
Male
63
  82.9%
1.Primary Outcome
Title Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48)
Hide Description [Not Specified]
Time Frame Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population (PP) included all participants without severe protocol violations, including major inclusion or exclusion criteria violations.
Arm/Group Title Pegylated Interferon (Peginterferon) Alfa-2a
Hide Arm/Group Description:
Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: percent change
59.13  (32.14)
2.Primary Outcome
Title Efficacy: Percentage of Participants With Serum Hepatitis B Surface Antigen (HBsAg) Decrease >/= 50% From Baseline at End of the Combination Treatment (Week 48)
Hide Description Participants who stopped pegylated interferon (PEG-IFN) treatment during the add-on phase due to serum HBsAg loss and HBsAg seroconversion were considered as responders.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations and who were undergoing the Week 48 visit.
Arm/Group Title Pegylated Interferon (Peginterferon) Alfa-2a
Hide Arm/Group Description:
Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
67.44
3.Secondary Outcome
Title Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96
Hide Description Change is calculated by HBsAg titer at baseline - HBsAg titer at week of assessments.
Time Frame Baseline, Week 24, 72 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations. Here, number of participants analyzed signifies those participants who were evaluable for the outcome measure and n signifies the number of participants who were evaluated at specified time points.
Arm/Group Title Pegylated Interferon (Peginterferon) Alfa-2a
Hide Arm/Group Description:
Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: international units per millilitre
Baseline (n= 56) 0  (0)
Change at Week 24 (n= 56) -546.32  (1215.20)
Change at Week 72 (n= 55) -815.69  (1394.89)
Change at Week 96 (n= 55) -728.16  (1418.60)
4.Secondary Outcome
Title Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48
Hide Description [Not Specified]
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations and who were undergoing the Week 48 visit.
Arm/Group Title Pegylated Interferon (Peginterferon) Alfa-2a
Hide Arm/Group Description:
Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
13.95
5.Secondary Outcome
Title Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96
Hide Description HBsAg loss is defined as HBsAg less than or equal to (</=) 0.05 IU/ml.
Time Frame Week 12 up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations.
Arm/Group Title Pegylated Interferon (Peginterferon) Alfa-2a
Hide Arm/Group Description:
Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: participants
1
6.Secondary Outcome
Title Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes
Hide Description [Not Specified]
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected, and the outcome measure was not analyzed.
Arm/Group Title Pegylated Interferon (Peginterferon) Alfa-2a
Hide Arm/Group Description:
Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels
Hide Description [Not Specified]
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected, and the outcome measure was not analyzed.
Arm/Group Title Pegylated Interferon (Peginterferon) Alfa-2a
Hide Arm/Group Description:
Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Safety: Percentage of Participants With Adverse Events (AE)
Hide Description An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received least one dose of the study drug and had at least one post-dose safety assessment.
Arm/Group Title Pegylated Interferon (Peginterferon) Alfa-2a
Hide Arm/Group Description:
Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: percentage of participants
92.75
Time Frame Baseline up to Week 48
Adverse Event Reporting Description Safety Population: Safety population included all participants who received least one dose of the study drug and had at least one post-dose safety assessment.
 
Arm/Group Title Pegylated Interferon (Peginterferon) Alfa-2a
Hide Arm/Group Description Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
All-Cause Mortality
Pegylated Interferon (Peginterferon) Alfa-2a
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pegylated Interferon (Peginterferon) Alfa-2a
Affected / at Risk (%)
Total   5/69 (7.25%) 
Endocrine disorders   
Papillary thyroid cancer  1  1/69 (1.45%) 
General disorders   
Pyrexia  1  1/69 (1.45%) 
Injury, poisoning and procedural complications   
Rib fracture  1  1/69 (1.45%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion  1  1/69 (1.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Squamous cell carcinoma of skin  1  1/69 (1.45%) 
Respiratory, thoracic and mediastinal disorders   
Hemoptysis  1  1/69 (1.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pegylated Interferon (Peginterferon) Alfa-2a
Affected / at Risk (%)
Total   56/69 (81.16%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1  8/69 (11.59%) 
Gastrointestinal disorders   
Diarrhoea  1  5/69 (7.25%) 
General disorders   
Asthenia  1  27/69 (39.13%) 
Fatigue  1  4/69 (5.80%) 
Pyrexia  1  18/69 (26.09%) 
Metabolism and nutrition disorders   
Decreased appetite  1  6/69 (8.70%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  6/69 (8.70%) 
Back pain  1  6/69 (8.70%) 
Musculoskeletal pain  1  11/69 (15.94%) 
Myalgia  1  15/69 (21.74%) 
Nervous system disorders   
Headache  1  19/69 (27.54%) 
Psychiatric disorders   
Insomnia  1  7/69 (10.14%) 
Irritability  1  6/69 (8.70%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/69 (7.25%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  4/69 (5.80%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
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-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01706575     History of Changes
Other Study ID Numbers: ML28262
2012-000080-25 ( EudraCT Number )
First Submitted: October 10, 2012
First Posted: October 15, 2012
Results First Submitted: June 24, 2016
Results First Posted: August 5, 2016
Last Update Posted: February 20, 2017