Trial Outcomes & Findings for 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 (NCT NCT01706575)

NCT ID: NCT01706575

Last Updated: 2017-02-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 76 participants
• Primary outcome timeframe: Baseline up to Week 48
• Results posted on: 2017-02-20

Participant Flow

A total of 76 participants started the study and were included in lead-in period. Out of 76 participants, 70 received study drug.

Participant milestones

Measure	Pegylated Interferon (Peginterferon) Alfa-2a 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 Study STARTED	76
Overall Study Treated	70
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	Pegylated Interferon (Peginterferon) Alfa-2a 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 Study Participant Withdrew Consent	4
Overall Study Lost to Follow-up	2
Overall Study Started but not Treated	6

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Pegylated Interferon (Peginterferon) Alfa-2a n=76 Participants 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.
Age, Continuous	49.82 years STANDARD_DEVIATION 8.46 • n=5 Participants
Gender Female	13 Participants n=5 Participants
Gender Male	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 48

Population: Per-Protocol Population (PP) included all participants without severe protocol violations, including major inclusion or exclusion criteria violations.

Outcome measures

Measure	Pegylated Interferon (Peginterferon) Alfa-2a n=43 Participants 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.
Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48)	59.13 percent change Standard Deviation 32.14

PRIMARY outcome

Timeframe: Baseline and Week 48

Population: PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations and who were undergoing the Week 48 visit.

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.

Outcome measures

Measure	Pegylated Interferon (Peginterferon) Alfa-2a n=43 Participants 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.
Efficacy: Percentage of Participants With Serum Hepatitis B Surface Antigen (HBsAg) Decrease >/= 50% From Baseline at End of the Combination Treatment (Week 48)	67.44 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24, 72 and 96

Population: 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.

Change is calculated by HBsAg titer at baseline - HBsAg titer at week of assessments.

Outcome measures

Measure	Pegylated Interferon (Peginterferon) Alfa-2a n=56 Participants 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.
Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96 Baseline (n= 56)	0 international units per millilitre Standard Deviation 0
Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96 Change at Week 24 (n= 56)	-546.32 international units per millilitre Standard Deviation 1215.20
Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96 Change at Week 72 (n= 55)	-815.69 international units per millilitre Standard Deviation 1394.89
Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96 Change at Week 96 (n= 55)	-728.16 international units per millilitre Standard Deviation 1418.60

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations and who were undergoing the Week 48 visit.

Outcome measures

Measure	Pegylated Interferon (Peginterferon) Alfa-2a n=43 Participants 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.
Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48	13.95 percentage of participants

SECONDARY outcome

Timeframe: Week 12 up to Week 96

Population: PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations.

HBsAg loss is defined as HBsAg less than or equal to (</=) 0.05 IU/ml.

Outcome measures

Measure	Pegylated Interferon (Peginterferon) Alfa-2a n=56 Participants 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.
Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96	1 participants

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: Data were not collected, and the outcome measure was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: Data were not collected, and the outcome measure was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Week 48

Population: Safety population included all participants who received least one dose of the study drug and had at least one post-dose safety assessment.

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.

Outcome measures

Measure	Pegylated Interferon (Peginterferon) Alfa-2a n=69 Participants 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.
Safety: Percentage of Participants With Adverse Events (AE)	92.75 percentage of participants

Adverse Events

Pegylated Interferon (Peginterferon) Alfa-2a

Serious events: 5 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pegylated Interferon (Peginterferon) Alfa-2a n=69 participants at risk 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.
Endocrine disorders Papillary thyroid cancer	1.4% 1/69 • Baseline up to Week 48 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.
General disorders Pyrexia	1.4% 1/69 • Baseline up to Week 48 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.
Injury, poisoning and procedural complications Rib fracture	1.4% 1/69 • Baseline up to Week 48 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.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.4% 1/69 • Baseline up to Week 48 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	1.4% 1/69 • Baseline up to Week 48 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.
Respiratory, thoracic and mediastinal disorders Hemoptysis	1.4% 1/69 • Baseline up to Week 48 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.

Other adverse events

Measure	Pegylated Interferon (Peginterferon) Alfa-2a n=69 participants at risk 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.
Blood and lymphatic system disorders Thrombocytopenia	11.6% 8/69 • Baseline up to Week 48 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.
Gastrointestinal disorders Diarrhoea	7.2% 5/69 • Baseline up to Week 48 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.
General disorders Asthenia	39.1% 27/69 • Baseline up to Week 48 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.
General disorders Fatigue	5.8% 4/69 • Baseline up to Week 48 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.
General disorders Pyrexia	26.1% 18/69 • Baseline up to Week 48 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.
Metabolism and nutrition disorders Decreased appetite	8.7% 6/69 • Baseline up to Week 48 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.
Musculoskeletal and connective tissue disorders Arthralgia	8.7% 6/69 • Baseline up to Week 48 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.
Musculoskeletal and connective tissue disorders Back pain	8.7% 6/69 • Baseline up to Week 48 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.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	15.9% 11/69 • Baseline up to Week 48 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.
Nervous system disorders Headache	27.5% 19/69 • Baseline up to Week 48 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.
Psychiatric disorders Insomnia	10.1% 7/69 • Baseline up to Week 48 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.
Respiratory, thoracic and mediastinal disorders Cough	7.2% 5/69 • Baseline up to Week 48 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.
Skin and subcutaneous tissue disorders Pruritus	5.8% 4/69 • Baseline up to Week 48 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.
Musculoskeletal and connective tissue disorders Myalgia	21.7% 15/69 • Baseline up to Week 48 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.
Psychiatric disorders Irritability	8.7% 6/69 • Baseline up to Week 48 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.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER